The report on the Cryonics Technology market provides a birds eye view of the current proceeding within the Cryonics Technology market. Further, the report also takes into account the impact of the novel COVID-19 pandemic on the Cryonics Technology market and offers a clear assessment of the projected market fluctuations during the forecast period. The different factors that are likely to impact the overall dynamics of the Cryonics Technology market over the forecast period (2019-2029) including the current trends, growth opportunities, restraining factors, and more are discussed in detail in the market study.

The recent published research report sheds light on critical aspects of the global Cryonics Technology market such as vendor landscape, competitive strategies, market drivers and challenges along with the regional analysis. The report helps the readers to draw a suitable conclusion and clearly understand the current and future scenario and trends of global Cryonics Technology market. The research study comes out as a compilation of useful guidelines for players to understand and define their strategies more efficiently in order to keep themselves ahead of their competitors. The report profiles leading companies of the global Cryonics Technology market along with the emerging new ventures who are creating an impact on the global market with their latest innovations and technologies.

Get Free Sample PDF (including COVID19 Impact Analysis, full TOC, Tables and Figures) of Market Report @ https://www.marketresearchhub.com/enquiry.php?type=S&repid=2637235&source=atm

The recent published study includes information on key segmentation of the global Cryonics Technology market on the basis of type/product, application and geography (country/region). Each of the segments included in the report is studies in relations to different factors such as market size, market share, value, growth rate and other quantitate information.

The competitive analysis included in the global Cryonics Technology market study allows their readers to understand the difference between players and how they are operating amounts themselves on global scale. The research study gives a deep insight on the current and future trends of the market along with the opportunities for the new players who are in process of entering global Cryonics Technology market. Market dynamic analysis such as market drivers, market restraints are explained thoroughly in the most detailed and easiest possible manner. The companies can also find several recommendations improve their business on the global scale.

The readers of the Cryonics Technology Market report can also extract several key insights such as market size of varies products and application along with their market share and growth rate. The report also includes information for next five years as forested data and past five years as historical data and the market share of the several key information.

Do You Have Any Query Or Specific Requirement? Ask to Our Industry [emailprotected] https://www.marketresearchhub.com/enquiry.php?type=E&repid=2637235&source=atm

Global Cryonics Technology Market by Companies:

The company profile section of the report offers great insights such as market revenue and market share of global Cryonics Technology market. Key companies listed in the report are:

The key players covered in this studyPraxairCellulisCryologicsCryothermKrioRusVWRThermo Fisher ScientificCustom Biogenic SystemsOregon CryonicsAlcor Life Extension FoundationOsiris CryonicsSigma-AldrichSouthern Cryonics

Market segment by Type, the product can be split intoSlow freezingVitrificationUltra-rapidMarket segment by Application, split intoAnimal husbandryFishery scienceMedical sciencePreservation of microbiology cultureConserving plant biodiversity

Market segment by Regions/Countries, this report coversNorth AmericaEuropeChinaJapanSoutheast AsiaIndiaCentral & South America

The study objectives of this report are:To analyze global Cryonics Technology status, future forecast, growth opportunity, key market and key players.To present the Cryonics Technology development in North America, Europe, China, Japan, Southeast Asia, India and Central & South America.To strategically profile the key players and comprehensively analyze their development plan and strategies.To define, describe and forecast the market by type, market and key regions.

In this study, the years considered to estimate the market size of Cryonics Technology are as follows:History Year: 2015-2019Base Year: 2019Estimated Year: 2020Forecast Year 2020 to 2026For the data information by region, company, type and application, 2019 is considered as the base year. Whenever data information was unavailable for the base year, the prior year has been considered.

Global Cryonics Technology Market by Geography:

You can Buy This Report from Here @ https://www.marketresearchhub.com/checkout?rep_id=2637235&licType=S&source=atm

Some of the Major Highlights of TOC covers in Cryonics Technology Market Report:

Chapter 1: Methodology & Scope of Cryonics Technology Market

Chapter 2: Executive Summary of Cryonics Technology Market

Chapter 3: Cryonics Technology Industry Insights

Chapter 4: Cryonics Technology Market, By Region

Chapter 5: Company Profile

And Continue

See original here:
Global trade impact of the Coronavirus Cryonics Technology Market Augmented Expansion to Be Registered by 2019-2049 - Latest Herald

Recommendation and review posted by Bethany Smith

CALGARY May 2, 2020 (Thomson StreetEvents) -- Edited Transcript of TC Energy Corp earnings conference call or presentation Friday, May 1, 2020 at 7:00:00pm GMT

* Donald R. Marchand

* Paul E. Miller

* Russell K. Girling

TransCanada PipeLines Limited - Executive VP, President of U.S. Natural Gas Pipelines & Diversity Officer

* Tracy A. Robinson

TC Energy Corporation - Executive VP & President of Canadian Natural Gas Pipelines

* Andrew M. Kuske

Crdit Suisse AG, Research Division - MD, Head of Canadian Equity Research, and Global Co-ordinator for Infrastructure Research

Tudor, Pickering, Holt & Co. Securities, Inc., Research Division - Director of Midstream Research

CIBC Capital Markets, Research Division - Executive Director of Institutional Equity Research

* Shneur Z. Gershuni

UBS Investment Bank, Research Division - Executive Director in the Energy Group and Analyst

Good afternoon, ladies and gentlemen. Welcome to the TC Energy 2020 First Quarter Results Conference Call.

I would now like to turn the meeting over to Mr. David Moneta, Vice President, Investor Relations. Please go ahead, Mr. Moneta.

Thank you, and thanks very much, and good afternoon, everyone. I'd like to welcome you to TC Energy's 2020 First Quarter Conference Call.

Joining me today are Russ Girling, President and Chief Executive Officer; Don Marchand, Executive Vice President, Strategy and Corporate Development and Chief Financial Officer; Franois Poirier, Chief Operating Officer and President, Power and Storage and Mexico; Tracy Robinson, President, Canadian Natural Gas Pipelines; Stan Chapman, President, U.S. Natural gas pipelines; Paul Miller, President, Liquids Pipelines; Bevin Wirzba, Senior Vice President, Liquids Pipelines; and Glenn Menuz, Vice President and Controller. Russ and Don will begin today with some opening comments on our financial results and certain other company developments.

A copy of the slide presentation that will accompany their remarks is available on our website. It can be found in the Investors section under the heading Events and Presentations.

Following their prepared remarks, we will take questions from the investment community. If you are a member of the media, please contact Jaimie Harding following this call and should be happy to address your questions.

In order to provide everyone from the investment community with an equal opportunity to participate, we ask that you limit yourself to 2 questions. If you have additional questions, please reenter the queue.

Also, we ask that you focus your questions on our industry, our corporate strategy, recent developments and key elements of our financial performance.

If you have detailed questions relating to some of our smaller operations, for your detailed financial models, Hunter and I would be pleased to discuss them with you following the call.

Before Russ begins, I'd like to remind you that our remarks today will include forward-looking statements that are subject to important risks and uncertainties. For more information on these risks and uncertainties, please see the reports filed by TC Energy with Canadian securities regulators and with the U.S. Securities and Exchange Commission.

And finally, during this presentation, we'll refer to measures such as comparable earnings per share, comparable earnings before interest, taxes, depreciation and amortization or comparable EBITDA and comparable funds generated from operations.

These and certain other comparable measures are considered to be non-GAAP measures. As a result, they may not be comparable to similar measures presented by other entities.

They are used to provide you with additional information on TC Energy's operating performance, liquidity and its ability to generate funds to finance its operations.

With that, I'll now turn the call over to Russ.

--------------------------------------------------------------------------------

Russell K. Girling, TC Energy Corporation - President, CEO & Director [3]

--------------------------------------------------------------------------------

Thank you, David, and good afternoon, everyone, and thank you all very much for joining us today.

Clearly, we're living in an unprecedented times with COVID-19, the pandemic having a significant impact on millions of people around the world. So on behalf of TC Energy, I'd like to start by expressing my sincere thanks to the frontline health care and other essential service workers who are risking their personal safety to ensure the well-being of others. Your selfless acts during this difficult time are truly courageous.

At TC Energy, as always, we too are focused on health and safety of our employees, our contractors and the communities in which we operate. When the World's Health Organization declared COVID-19 a global pandemic in early March, our business continuity plans were put in place across the organization, allowing us to continue to effectively operate our assets and execute on our capital programs.

The services we provide are broadly considered essential are critical in Canada, the United States and Mexico, given the important role our infrastructure plays in delivering energy to people across the continent. And at the responsibility we take very seriously, like many others, thousands of our employees are now working remotely, while those that must be physically at our work sites are following rigorous health, hygiene and distancing protocols.

I want to acknowledge and thank our employees and their families for their ongoing efforts to ensure the energy that is vital to the daily lives of so many continues to be delivered seamlessly across North America, and your efforts are truly making a difference.

Turning now to our first quarter financial results and certain other recent developments across our 3 core businesses, with approximately 95% of our comparable EBITDA coming from regulated or long-term contracted assets. We are largely insulated from the volatility associated with volume throughput and the commodity prices that are being experienced by many others.

Aside from the impact of normal maintenance activities and seasonal factors to date, we have not seen any meaningful change in the utilization of our assets, which further reinforces their critical nature to North America. As a result, as highlighted in our first quarter report, our $100 billion portfolio, high-quality, long life energy infrastructure assets continue to produce strong financial results.

And we continue to capitalize or we continue to realize the growth expected from our industry-leading capital program. Today, that program that we're advancing, it's $43 billion of secured capital projects, and it now includes Keystone XL.

In addition, we continue to advance more than $10 billion of projects under development, including the refurbishment of another 5 reactors at Bruce Power as part of their long-term life extension program. Over the last 4 months, we took significant steps to fund our 2020 capital expenditure program and to maintain our strong financial position despite challenging capital market conditions.

More specifically, we enhanced our liquidity by more than $9 billion through the issuance of long-term debt in both Canada and the United States at very attractive rates, the establishment of incremental committed credit facilities and the sale of 3 Ontario natural gas-fired power plants.

When combined with our predictable and growing cash flow from operations and the sale of a 65% interest in the Coastal GasLink project, which is scheduled to close in the second quarter, we believe that we're very well positioned to continue to fund our capital program and other obligations through a prolonged period of disruption in capital markets if that was to occur.

Looking forward, we expect our solid operating and financial performance to continue with 2020 comparable earnings per share is still anticipated to be similar to the recorded -- or the record results that we produced in 2019. While we're proud of our financial performance and the significant returns we've generated for our shareholders, we know that our ongoing success depends on our ability to balance profitability with safety and environmental and social responsibility.

We have a 65-year track record of safe and reliable operations, but we recognize that we can always improve. To keep you better informed, we have published several investor-focused ESG documents over the past year. They described some of the work we're doing to ensure our business remains resilient in an ever-evolving energy landscape. All of this can be found on our website at tcenergy.com.

With that as an overview, I'll explain some of the recent developments beginning with a brief review of our first quarter financial results. Don will provide more detail of our results and liquidity in just a few minutes.

Excluding certain specific items, comparable earnings were $1.1 billion or $1.18 per common share for the 3 months ended March 31 compared to $1 billion or $1.07 per share in 2019, which was an increase of 10% on a per share basis. Comparable EBITDA of $2.5 billion was 6% higher and the amount reported for the same period last year, while comparable funds generated from operations was $2.1 billion, which was 17% higher than the comparable period.

Each of these amounts reflects the strong performance of our legacy assets as well as contributions from another $1.6 billion of new long-term contracted and rate-regulated assets placed into service in early 2020.

Next, I'll make a few comments on our 3 core businesses, starting with our natural gas pipeline business. Customer demand for our services remained strong despite the COVID-19 impacts on the broader North American economy. Evidence of this can be seen in the volumes transported across our systems with the NGTL System field receipts averaging about 12.2 Bcf a day. The Canadian Mainline Western receipts averaging 3.2 Bcf a day. Our broader U.S. pipeline network moving approximately 26 Bcf a day, and our Mexican pipelines moving approximately 1.5 Bcf a day. Each of these amounts are similar to or greater than the volumes moved over the same period last year. At the same time, we continue to advance more than $27 billion of capital projects associated with our natural gas pipeline businesses.

The program includes significant expansion of our NGTL System, capacity additions of our -- to our U.S. network, the Villa de Reyes pipeline, the Tula project and our Coastal GasLink pipeline project in British Columbia, which will play an important role in delivering Canadian natural gas to Asian markets.

While it's too early to determine whether the COVID-19 pandemic will have any long-term impacts on our capital programs, what I would say is directionally, we would expect some slowdown of our construction activities in capital expenditure in 2020 because of the global health crisis and the impact, the COVID-related safety protocols will have on our construction productivity.

Finally, in natural gas pipelines, last week, we are pleased to announce a 5-year revenue requirement settlement with our customers on the NGTL System. The settlement, which runs from January 2020 through December 2024, sets a base equity return of 10.1% on 40% deemed common equity and includes incentive mechanisms for certain operating costs where variances from projected amounts would be shared between TC Energy and our customers.

The settlement was a result of a collaborative process between us and our customers and is responsive to their needs during this challenging time while providing us with a stable return as we invest billions of dollars in pipeline infrastructure to enhance their connectivity of natural gas supply to premium markets.

Turning now to our liquids pipeline business, which generated solid results during the first quarter, despite extraordinary volatility in global crude oil markets. While the volatility did have an impact on our market link and liquids marketing bigger businesses, Keystone continued to produce solid results as it serves an important market in the U.S. Midwest and Gulf Coast and is underpinned by long-term take-or-pay contracts with strong counterparties.

Also in Liquids Pipelines, we recently announced that we would commence construction of Keystone pipeline or the Keystone XL pipeline. Keystone XL is the fourth phase of the Keystone system and continues to be a very important project for both Canada and the United States. It will create thousands of jobs, advanced energy security for both nations in an environmentally and sustainable way. The project is underpinned by a new 20-year take-or-pay contracts that are expected to generate approximately USD 1.3 billion of incremental EBITDA on an annual basis once the pipeline is placed into service.

Keystone XL will require an additional investment of approximately USD 8 billion and is expected to enter service in 2023. To advance the project, we have entered into a partnership with the government of Alberta, who will invest approximately $1.1 billion of equity into the project and fully guarantee a USD 4.2 billion project level credit facility. Once the project is completed and placed into service, we expect to acquire the Alberta government's equity investment and refinance the credit facility.

We appreciate the ongoing backing of landowners, customers, indigenous groups and numerous other partners in the U.S. and Canada, who have helped us secure project support and key regulatory approvals for this very important energy infrastructure project.

In addition, I'd like to thank the many government officials across North America for their support without which this project could not have advanced.

Moving forward, we will continue to carefully manage various legal and regulatory matters as we construct this pipeline, which will have the capacity to move about 830,000 barrels a day of responsibly produced energy from the Canadian oil sands to the continent's largest refining market in the U.S. Gulf Coast.

Turning now to Power and Storage, where Bruce Power continued to produce solid results through the first 3 months of this year. After years of preparation, in January, Bruce Power commenced work on the Unit 6 Major Component Replacement, or MCR outage, when they took it off-line here in January. We expect to invest approximately $2.4 billion in that program as well as the ongoing asset management program through 2023 when the Unit 6 refurbishment is targeted to be done.

Unfortunately, because of COVID-19 on March 25, 2020, Bruce Power declared force majeure under its contract with the independent electric system operator. This force majeure notice covers the Unit 6 MCR and certain asset management work. At the time, the force majeure was declared, the Unit 6 MCR program was ahead of schedule.

Despite the force majeure, Bruce Power has been able to continue limited work on critical path activities as well as training for the MCR contractors. In late April, remobilization of the MCR workforce began with strict COVID-19 measures in place with respect to worker safety. The measures include shift adjustments to reduce headcount, increased personal protective equipment, physical distancing and a reduction in noncritical work.

Operations and planned outages on all other units are expected to continue as normal. Finally, in power, earlier this week, we completed the sale of 3 natural gas-fired power plants in Ontario, Napanee, Halton Hills and our interest in the Portlands Energy Center. Net proceeds of approximately $2.8 billion will be used to help fund our industry-leading capital program.

So in summary, today, we are advancing $43 billion secured growth projects that are expected to enter service by 2023. We have invested approximately $12 billion into this program to date with approximately $6 billion of these projects expected to be completed by the end of 2020. Notably, they are all underpinned by cost of service regulation or long-term contracts, giving us visibility to earnings and cash flow they will generate as they enter service.

Based on the strength of our recent financial performance and our promising outlook for the future, in February, TC Energy's Board of Directors declared a first quarter 2020 dividend of $0.81 per common share, which is equivalent to $3.24 on an annual basis. This represents an 8% increase over the amount declared for the same period in 2019 and is the 20th consecutive year that our Board of Directors has raised the dividend.

Over that same time frame, we have maintained consistently strong coverage ratios with our dividend, on average, representing a payout of approximately 80% of comparable earnings and 40% of comparable funds generated from operations leaving us with significantly internally-generated cash flow to invest in our businesses.

Based on the continued strong performance of our base business, the organic growth and the organic growth we expect to realize as we advance our $43 billion secured capital program, we expect our dividend to grow at an annual average rate of 8% to 10% through 2021 and 5% to 7% thereafter.

So in summary, I'd leave you with the following key messages. Today, we are a leading North American energy infrastructure company with a strong track record of delivering long-term shareholder value. Our assets provide an essential service to the functioning of the North American society and its economy and the demand for our services remain strong.

Looking forward, we have 5 significant platforms for growth: Canadian, U.S. and Mexican Natural Gas Pipelines, Liquids Pipelines and Power and Storage. As we advance our $43 billion secured capital program, we expect to build on our long track record of growing earnings, cash flow and dividends per share.

We have also more than $10 billion of projects in the advanced stages of development and expect numerous other in corridor organic growth opportunities to emanate from our extensive critical asset footprints.

Looking forward, (technical difficulty) working in accordance with our values and responding quickly to market signals and sign posts to ensure we remain industry-leading and resilient as we continue to grow shareholder value.

I'll now turn the call over to Don, who will provide more details on our first quarter results and our financial position. Don, over to you.

--------------------------------------------------------------------------------

Donald R. Marchand, TC Energy Corporation - Executive VP of Strategy & Corporate Development and CFO [4]

--------------------------------------------------------------------------------

Thanks, Russ. Good afternoon, everyone. As outlined in our results issued earlier today, net income attributable to common shares was $1.15 billion or $1.22 per share in the first quarter of 2020 compared to $1 billion or $1.09 per share for the same period in 2019.

First quarter results included a positive $281 million income tax valuation allowance release following our reassessment of deferred tax assets that are deemed more likely than not to be realized as a result of our decision to proceed with Keystone XL. This was partially offset by an incremental after-tax loss of $77 million related to the Ontario natural gas-fired power plants held for sale. First quarter 2019 also included certain specific items outlined on the slide and discussed further in our first quarter 2020 report to shareholders.

These specific items as well as unrealized gains and losses from changes in risk management activities are excluded from comparable earnings.

Comparable earnings in the first quarter rose by $122 million to $1.1 billion or $1.18 per share compared to $987 million or $1.07 per share in 2019, representing a 10% increase on a per share basis.

Turning to our business segment results on Slide 14. In the first quarter, comparable EBITDA from our 5 operating segments was $2.5 billion, a $152 million increase compared to 2019. Canadian Natural Gas Pipelines comparable EBITDA of $597 million was $41 million higher than the same period last year, primarily on account of increased rate base earnings as well as flow through depreciation and financial charges on the NGTL System from additional facilities placed in service. This was partially offset by lower flow through income taxes on both the NGTL System and the Canadian Mainline as a result of accelerated tax depreciation measures enacted by the Canadian federal government in June 2019.

NGTL System net income increased $22 million compared to first quarter 2019 as a result of a higher average investment base and continued system expansions and reflects an ROE of 10.1% on 40% deemed equity. Net income for the Canadian Mainline decreased $5 million year-over-year, largely due to lower incentive earnings.

U.S. natural gas pipelines comparable EBITDA of USD 766 million or CAD 1.032 billion in the quarter rose by USD 36 million or CAD 60 million compared to the same period in 2019. The increase was mainly due to contributions from Columbia Gas and Columbia Gulf growth projects placed in service, partially offset by the sale of certain Columbia midstream assets in August 2019.

Mexico Natural Gas pipelines comparable EBITDA of USD 198 million or CAD 269 million was USD 88 million or CAD 123 million above first quarter 2019. The increase was primarily due to higher earnings in Sur de Texas, including USD 55 million associated with onetime fees realized as a result of the successful completion of the project compared to contract targets as well as fees received from operating the pipeline.

Liquids Pipelines comparable EBITDA declined by $118 million to $445 million in first quarter 2020, driven by lower uncontracted volumes on the Keystone pipeline system, a decreased contribution from liquids marketing activities due to lower margins and reduced earnings as a result of the partial monetization of Northern Courier in July 2019.

Power and Storage comparable EBITDA rose by $43 million year-over-year to $194 million due to higher Bruce Power results, which were augmented by an increased realized power price and higher production resulting from fewer outage days, partially offset by losses on funds invested for post-retirement benefits.

The higher contribution from Bruce Power was modestly offset by lower Canadian power results, largely due to an outage at our Mackay River cogeneration facility, which began late fourth quarter 2019 and the sale of the Coolidge generating station in May 2019. For all our businesses with U.S. dollar-denominated income, including U.S. natural gas pipelines, Mexico Natural Gas Pipelines and parts of Liquids Pipelines, EBITDA was translated into Canadian dollars using an average exchange rate of CAD 1.34 in first quarter 2020 compared similar to the rate used for the same period in 2019.

As a reminder of our approach to managing foreign exchange exposure, our U.S. dollar-denominated revenue streams are partially hedged by interest on U.S. dollar-denominated debt. We then actively managed the residual exposure on a rolling 1-year forward basis with realized gains and losses on this program reflected in comparable interest income and other.

Now turning to the other income statement items on Slide 15. Depreciation and amortization of $630 million increased $22 million versus first quarter 2019, largely due to new projects placed in service in Canadian Natural Gas Pipelines and U.S. Natural Gas Pipelines. Depreciation of Canadian Natural Gas Pipelines is recoverable in tolls on a flow-through basis.

Interest expense of $578 million for first quarter 2020 was $8 million lower year-over-year, primarily due to the net effect of higher capitalized interest related to Coastal GasLink and Keystone XL, lower interest rates on higher levels of short-term borrowings and long-term debt issuances net of maturities.

AFUDC decreased $57 million for the 3 months ended March 31, 2020, compared to the same period in 2019, largely due to Columbia Gas growth projects placed in service during 2019 and the suspension of recording AFUDC effective January 1, 2020, on Tula due to continuing construction delays.

Comparable interest income and other increased by $19 million in the first quarter versus 2019, primarily due to unrealized foreign exchange gains on peso-denominated deferred income tax liabilities, reflecting the weakening of the Mexican peso in first quarter 2020.

Income tax expense included in comparable earnings was $211 million in first quarter 2020 compared to $228 million for the same period last year. The $17 million decrease was mainly due to lower flow-through income taxes on Canadian rate-regulated pipelines, inclusive of a lower Alberta corporate income tax rate, partially offset by lower foreign tax rate differentials and increased pretax earnings.

Excluding Canadian rate-regulated pipelines, where income taxes are a flow-through item and thus quite variable, along with equity AFUDC income in U.S. and Mexico Natural Gas Pipelines, we expect our 2020 full year effective tax rate to be in the mid- to high teens after normalizing for these items.

Comparable net income attributable to noncontrolling interest of $96 million in the first quarter decreased by $5 million related to the same period last year, primarily due to lower earnings in TC PipeLines, LP. And finally, preferred share dividends were comparable to first quarter 2019.

Now turning to Slide 16. During the first quarter, we invested approximately $2.3 billion in our capital program, which reflects 100% of Coastal GasLink spending pending close of the equity sale of the KKR and AIMCo expected in the second quarter. Capital expenditures were largely funded with comparable funds generated from operations of $2.1 billion, along with cash on hand and notes payable.

As everyone is acutely aware, capital market conditions have been significantly impacted by COVID-19, resulting in periods of dramatically heightened volatility and reduced liquidity. In response to this, we secured approximately $6.6 billion of additional financial capacity in early April through long-term debt issuances in Canada and the U.S. on compelling terms, along with the establishment of USD 2 billion of incremental committed credit facilities.

Our solid financial position was bolstered earlier this week with the completion of the disposition of our 3 Ontario natural gas-fired power plants for $2.8 billion.

The sale will result in a final estimated after-tax loss of $370 million, of which $271 million was realized at March 31, 2020. The remaining amount will be recorded on close and reflected in second quarter 2020 results.

These transactions have collectively added over $9 billion in incremental liquidity over the past months, enhancing our financial flexibility and demonstrating our continued access to capital markets under stressed market conditions.

Looking forward, our financial strength will improve further upon completing the partial monetization of and establishing project level financing for Coastal GasLink. In late April, we executed a credit agreement with the syndicate of banks extending nonrecourse project level financing to fund the majority of the project's construction costs.

The credit facilities will be available to be drawn once conditions precedent have been met, including the closing of the equity purchase agreement with KKR and AIMCo, which is expected to occur in the second quarter.

As was highlighted, we have also secured government of Alberta support for Keystone XL in the form of a USD 1.1 billion equity contribution and USD 4.2 billion loan guarantee.

Read this article:
Edited Transcript of TRP.TO earnings conference call or presentation 1-May-20 7:00pm GMT - Yahoo Finance

Recommendation and review posted by Bethany Smith

Updated: May 25, 2018:

JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.

This Privacy Policy describes how JD Supra, LLC ("JD Supra" or "we," "us," or "our") collects, uses and shares personal data collected from visitors to our website (located at http://www.jdsupra.com) (our "Website") who view only publicly-available content as well as subscribers to our services (such as our email digests or author tools)(our "Services"). By using our Website and registering for one of our Services, you are agreeing to the terms of this Privacy Policy.

Please note that if you subscribe to one of our Services, you can make choices about how we collect, use and share your information through our Privacy Center under the "My Account" dashboard (available if you are logged into your JD Supra account).

Registration Information. When you register with JD Supra for our Website and Services, either as an author or as a subscriber, you will be asked to provide identifying information to create your JD Supra account ("Registration Data"), such as your:

Other Information: We also collect other information you may voluntarily provide. This may include content you provide for publication. We may also receive your communications with others through our Website and Services (such as contacting an author through our Website) or communications directly with us (such as through email, feedback or other forms or social media). If you are a subscribed user, we will also collect your user preferences, such as the types of articles you would like to read.

Information from third parties (such as, from your employer or LinkedIn): We may also receive information about you from third party sources. For example, your employer may provide your information to us, such as in connection with an article submitted by your employer for publication. If you choose to use LinkedIn to subscribe to our Website and Services, we also collect information related to your LinkedIn account and profile.

Your interactions with our Website and Services: As is true of most websites, we gather certain information automatically. This information includes IP addresses, browser type, Internet service provider (ISP), referring/exit pages, operating system, date/time stamp and clickstream data. We use this information to analyze trends, to administer the Website and our Services, to improve the content and performance of our Website and Services, and to track users' movements around the site. We may also link this automatically-collected data to personal information, for example, to inform authors about who has read their articles. Some of this data is collected through information sent by your web browser. We also use cookies and other tracking technologies to collect this information. To learn more about cookies and other tracking technologies that JD Supra may use on our Website and Services please see our "Cookies Guide" page.

We use the information and data we collect principally in order to provide our Website and Services. More specifically, we may use your personal information to:

JD Supra takes reasonable and appropriate precautions to insure that user information is protected from loss, misuse and unauthorized access, disclosure, alteration and destruction. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. You should keep in mind that no Internet transmission is ever 100% secure or error-free. Where you use log-in credentials (usernames, passwords) on our Website, please remember that it is your responsibility to safeguard them. If you believe that your log-in credentials have been compromised, please contact us at privacy@jdsupra.com.

Our Website and Services are not directed at children under the age of 16 and we do not knowingly collect personal information from children under the age of 16 through our Website and/or Services. If you have reason to believe that a child under the age of 16 has provided personal information to us, please contact us, and we will endeavor to delete that information from our databases.

Our Website and Services may contain links to other websites. The operators of such other websites may collect information about you, including through cookies or other technologies. If you are using our Website or Services and click a link to another site, you will leave our Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We are not responsible for the data collection and use practices of such other sites. This Policy applies solely to the information collected in connection with your use of our Website and Services and does not apply to any practices conducted offline or in connection with any other websites.

JD Supra's principal place of business is in the United States. By subscribing to our website, you expressly consent to your information being processed in the United States.

You can make a request to exercise any of these rights by emailing us at privacy@jdsupra.com or by writing to us at:

You can also manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard.

We will make all practical efforts to respect your wishes. There may be times, however, where we are not able to fulfill your request, for example, if applicable law prohibits our compliance. Please note that JD Supra does not use "automatic decision making" or "profiling" as those terms are defined in the GDPR.

Pursuant to Section 1798.83 of the California Civil Code, our customers who are California residents have the right to request certain information regarding our disclosure of personal information to third parties for their direct marketing purposes.

You can make a request for this information by emailing us at privacy@jdsupra.com or by writing to us at:

Some browsers have incorporated a Do Not Track (DNT) feature. These features, when turned on, send a signal that you prefer that the website you are visiting not collect and use data regarding your online searching and browsing activities. As there is not yet a common understanding on how to interpret the DNT signal, we currently do not respond to DNT signals on our site.

For non-EU/Swiss residents, if you would like to know what personal information we have about you, you can send an e-mail to privacy@jdsupra.com. We will be in contact with you (by mail or otherwise) to verify your identity and provide you the information you request. We will respond within 30 days to your request for access to your personal information. In some cases, we may not be able to remove your personal information, in which case we will let you know if we are unable to do so and why. If you would like to correct or update your personal information, you can manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard. If you would like to delete your account or remove your information from our Website and Services, send an e-mail to privacy@jdsupra.com.

We reserve the right to change this Privacy Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our Privacy Policy will become effective upon posting of the revised policy on the Website. By continuing to use our Website and Services following such changes, you will be deemed to have agreed to such changes.

If you have any questions about this Privacy Policy, the practices of this site, your dealings with our Website or Services, or if you would like to change any of the information you have provided to us, please contact us at: privacy@jdsupra.com.

As with many websites, JD Supra's website (located at http://www.jdsupra.com) (our "Website") and our services (such as our email article digests)(our "Services") use a standard technology called a "cookie" and other similar technologies (such as, pixels and web beacons), which are small data files that are transferred to your computer when you use our Website and Services. These technologies automatically identify your browser whenever you interact with our Website and Services.

We use cookies and other tracking technologies to:

There are different types of cookies and other technologies used our Website, notably:

JD Supra Cookies. We place our own cookies on your computer to track certain information about you while you are using our Website and Services. For example, we place a session cookie on your computer each time you visit our Website. We use these cookies to allow you to log-in to your subscriber account. In addition, through these cookies we are able to collect information about how you use the Website, including what browser you may be using, your IP address, and the URL address you came from upon visiting our Website and the URL you next visit (even if those URLs are not on our Website). We also utilize email web beacons to monitor whether our emails are being delivered and read. We also use these tools to help deliver reader analytics to our authors to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

Analytics/Performance Cookies. JD Supra also uses the following analytic tools to help us analyze the performance of our Website and Services as well as how visitors use our Website and Services:

Facebook, Twitter and other Social Network Cookies. Our content pages allow you to share content appearing on our Website and Services to your social media accounts through the "Like," "Tweet," or similar buttons displayed on such pages. To accomplish this Service, we embed code that such third party social networks provide and that we do not control. These buttons know that you are logged in to your social network account and therefore such social networks could also know that you are viewing the JD Supra Website.

If you would like to change how a browser uses cookies, including blocking or deleting cookies from the JD Supra Website and Services you can do so by changing the settings in your web browser. To control cookies, most browsers allow you to either accept or reject all cookies, only accept certain types of cookies, or prompt you every time a site wishes to save a cookie. It's also easy to delete cookies that are already saved on your device by a browser.

The processes for controlling and deleting cookies vary depending on which browser you use. To find out how to do so with a particular browser, you can use your browser's "Help" function or alternatively, you can visit http://www.aboutcookies.org which explains, step-by-step, how to control and delete cookies in most browsers.

We may update this cookie policy and our Privacy Policy from time-to-time, particularly as technology changes. You can always check this page for the latest version. We may also notify you of changes to our privacy policy by email.

If you have any questions about how we use cookies and other tracking technologies, please contact us at: privacy@jdsupra.com.

View post:
Biopharma Develops Antibody and Stem Cell Therapies in the Fight Against COVID-19 - JD Supra

Recommendation and review posted by Bethany Smith

Home Topics Lung Infection

Mesoblast announced data from a phase 2/3 trial evaluating remestemcel-L, an allogeneic mesenchymal stem cell product candidate, in ventilator-dependent COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS).

Remestemcel-L consists of culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. It is believed to work by down-regulating the production of proinflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.

The randomized, placebo-controlled trial is being conducted at Mount Sinai hospital in New York City. Patients were treated with a variety of experimental agents prior to receiving remestemcel-L. Findings from the study showed 83% survival in ventilator-dependent COVID-19 patients with moderate/severe ARDS (n=10/12) following 2 intravenous infusions of remestemcel-L within the first 5 days; 75% of patients (n=9/12) were able to successfully come off ventilator support at a median of 10 days. There have been 7 patients discharged from the hospital as of now.

Mesoblast Chief Executive Dr. Silviu Itescu stated: The remarkable clinical outcomes in these critically ill patients continue to underscore the potential benefits of remestemcel-L as an anti-inflammatory agent in cytokine release syndromes associated with high mortality, including acute graft versus host disease and COVID-19 ARDS. We intend to rapidly complete the randomized, placebo-controlled phase 2/3 trial in COVID-19 ARDS patients to rigorously confirm that remestemcel-L improves survival in these critically ill patients.

Additionally, the Food and Drug Administration recently accepted for Priority Review the Biologics License Application of remestemcel-L for the treatment of steroid-refractory acute graft vs host disease. The Company expects to launch remestemcel-L in 2020 if approved.

For more information mesoblast.com.

This article originally appeared on MPR

Please login or register first to view this content.

LoginRegister

Next post in Lung InfectionClose

Continue reading here:
Remestemcel-L Looks Promising for COVID-19 With Moderate to Severe ARDS - Pulmonology Advisor

Recommendation and review posted by Bethany Smith

In an unfortunate development, actor Rishi Kapoor lost his long battle with Leukemia. As we all know, the actor had travelled to the US for his treatment earlier and came back looking younger and healed. But he has had his share of health issues ever since. The family had been referring to the treatment as marrow and today the family confirmed that the actor was struggling with leukemia. Let us first understand what leukemia is - Leukemia is cancer of the body's blood-forming tissues, which includes the bone marrow as well as the lymphatic system. There are several types of leukemia, and some even affect the children, however, mostly leukemia occurs in adults. According to Cancer.org, most often, AML develops from cells that would turn into white blood cells (other than lymphocytes), but sometimes AML develops in other types of blood-forming cells. . To understand the course of treatment that the actor may have undergone, we spoke exclusively to subject matter expert Dr Rahul Bhargava, Director, Haematology, Haemato - Oncology and Bone Marrow Transplant, Fortis Memorial Research Institute, Gurugram. The doctor says the way it appears, the star must have suffered from Acute myeloid leukemia (AML) which is a cancer that starts in the bone marrow, which is the soft inner part of certain bones, where the body makes new blood cells. This often quickly moves into the blood, as well. Talking about the treatment for this particular illness, Dr Bhargava said, There is a possibility that he underwent a MUD (Match unrelated donor) transplant with reduced intensity conditioning (RIC), which basically means that he was given a lower intensity treatment, considering his age. How does MUD work?In MUD, stem cells from outside are injected in the body, and mature stem cells are targeted and removed. A person has to be in the hospital for close to 21-25 days for this procedure and then we wait and see how the body responds to the treatment. The doctor adds that clearly the treatment couldnt control his disease and he succumbed to it.

See more here:
Rishi Kapoor succumbs to Leukemia: Here is all we know about the condition and treatment - Times of India

Recommendation and review posted by Bethany Smith

Aging is an inevitable process. We cannot escape or prevent getting older but what if theres a fascinating field of medicine that can manage the aging process and prolong our health and vitality and longevity as we age?

Aging is an inevitable process. We cannot escape or prevent getting older but what if theres a fascinating field of medicine that can manage the aging process and prolong our health and vitality and longevity as we age?

Keeping in mind that there may never be an approach to totally stop or reverse aging, there have been some surprising disclosures to how Regenerative Medicine can naturally heal our body without the use of any surgical procedure.

Rejuvenating Old Cells to Healthy ones

The paces, stresses, and complexities in life drive us to age prematurely thereby breaking down our cells. Cell breakdown may lead to several health conditions like cancer, heart disease, Alzheimers and others.

Driving our bodies to age quickly, cell-breakdown is host to many age-related diseases, causing more than 100,000 deaths per day.

Dr David C Karli is an Ivy-trained physician, specialized in treating athletic injuries by inducing regenerative medicine and stem cell therapy in treatments.

He accepts the fact that patients can increase an additional 30 years of life by using Regenerative Medicine. One such innovation uses stem cells, however, there are issues with these cells.

They may not replace the original, diseased cells rapidly enough, or they may start to replicate uncontrollably, bringing about malignant growth.

Yet, Regenerative Medicine definitely guarantees the complete curing of a wide range of diseases, and ideally, slowing down the aging process too.

Stem Cell Therapy Programs with Promising Results

With solid funding and rapid advancements, one stem cell therapy that promises great outcomes is transfusions. In this therapy, stem cells are extracted from the patient and grown in cell culture to increase the number of cells. Following this, those cells are injected back into the patients body.

Dr. Karlis keen interest in Transfusions led him to create biologic products that can cause an age-related decline in a persons strength, endurance, and various other physical abilities.

At his biotech firm, Greyledge Technologies, biologic products are prepared by processing materials (blood or bone marrow) and implanting them into the human body to replicate the diseased tissues.

With an FDA-registered laboratory environment, the outcomes are promising and are an anti-aging protocol.

Telomeres may be the next-gen solution for Anti Aging

Telomeres are essential parts of our DNA that are connected to the premature aging cells. Situated at the end caps of our DNA strands, the information within Telomeres is lost while DNA replicates to the extent that they stop replicating.

If DNA replicates without losing information, scientists believe that Telomeres can significantly help to slow down the aging process.

Similar is the case with Metformin, a pharmaceutical reagent that improves wound healing. Proven to counteract aging, Metformin is now being tested for its unique ability to mimic calorie restriction.

Anti-Aging Through Regeneration

Utilizing induced tissue regeneration, this technology is a new approach to anti-aging treatment. Combining telomerase therapy and induced tissue regeneration, anti-aging through regeneration includes the study of the impact on age-related diseases like diabetes, metabolic disorders, cardiovascular disease, and others.

This technique focuses on the cells that are generated in our body during youth. As we age, these cells are lost and lead to a metabolic imbalance.

Scientists and Researchers are trying to find a way in which these cells can be restored to reverse the signs of aging and create a balance.

Humans have the ability to regenerate damaged and diseased tissues. However, this only happens during the first few weeks of development. With the help of Artificial Intelligence, scientists are trying to unlock this potential ability in humans.

The Future of Anti-Aging

With several breakthroughs on the horizon, cure-all promises and best outcomes, these anti-aging protocols have a long way to go.

While the introduction of regenerative medicine and stem cell therapies to redefine orthopedic treatment sounds like a miracle, there are still unexplored paths that need to be taken.

With all the benefits regenerative medicine has to offer, there will always be an eye on the never-ending search for the fountain of youth.

CLICK HERE FOR BREVARD COUNTY NEWS

Continued here:
Dr. David C. Karli's Opinion on Regenerative Medicine and Age Prevention | - SpaceCoastDaily.com

Recommendation and review posted by Bethany Smith

BACKGROUND:

Osteoporosisis a metabolic bone disease characterized by low bone density resulting in increased fracture susceptibility. This research was constructed to uncover the potential therapeutic application of osteoblasts transplantation, generated upon culturing male rat bone marrow-derived mesenchymal stem cells (BM-MSCs) in osteogenic medium (OM), OM containing gold (Au-NPs) or gold/hydroxyapatite (Au/HA-NPs) nanoparticles, in ovariectomized rats to counteractosteoporosis.

Forty rats were randomized into: (1) negative control, (2) osteoporotic rats, whereas groups (3), (4) and (5) constituted osteoporotic rats treated with osteoblasts yielded from culturing BM-MSCs in OM, OM plus Au-NPs or Au/HA-NPs, respectively. After 3months, osterix (OSX), bone alkaline phosphatase (BALP), sclerostin (SOST) and bone sialoprotein (BSP) serum levels were assessed. In addition, gene expression levels of cathepsin K, receptor activator of nuclear factor-b ligand (RANKL), osteoprotegerin (OPG) and RANKL/OPG ratio were evaluated using real-time PCR. Moreover, histological investigation of femur bone tissues in different groups was performed. The homing of implanted osteoblasts to the osteoporotic femur bone of rats was documented by Sex determining region Y gene detection in bone tissue.

Our results indicated that osteoblasts infusion significantly blunted serum BALP, BSP and SOST levels, while significantly elevated OSX level. Also, they brought about significant down-regulation in gene expression levels of cathepsin K, RANKL and RANKL/OPG ratio versus untreated osteoporotic rats. Additionally, osteoblasts nidation could restore bone histoarchitecture.

These findings offer scientific evidence that transplanting osteoblasts in osteoporotic rats regains the homeostasis of the bone remodeling cycle, thus providing a promising treatment strategy for primaryosteoporosis.

Link:
Osteoblast-Based Therapy-A New Approach for Bone Repair in Osteoporosis: Pre-Clinical Setting - DocWire News

Recommendation and review posted by Bethany Smith

DetailsCategory: AntibodiesPublished on Saturday, 02 May 2020 12:42Hits: 143

- Innovative, fixed-dose formulation significantly reduces treatment time from hours to minutes and demonstrates consistent efficacy with a reduction in administration-related reactions compared to DARZALEX (daratumumab) for approved indications

- DARZALEX FASPRO is the only subcutaneous CD38-directed antibody approved in the treatment of multiple myeloma

HORSHAM, PA, USA I May 1, 2020 I The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approved DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a new subcutaneous formulation of daratumumab. DARZALEX FASPRO is approved in four regimens across five indications in multiple myeloma patients, including newly diagnosed, transplant-ineligible patients as well as relapsed or refractory patients.As a fixed-dose formulation, DARZALEX FASPRO can be administered over approximately three to five minutes, significantly less time than DARZALEX,which is given intravenously over hours. In the Phase 3 COLUMBA study supporting the approval, DARZALEX FASPRO demonstrated a consistent overall response rate (ORR) and pharmacokinetics and a similar safety profile compared with intravenous DARZALEX in patients with relapsed or refractory multiple myeloma. In addition, there was a nearly two-thirds reduction in systemic administration-related reactions (ARRs) for DARZALEX FASPRO compared to intravenous DARZALEX (13 percent vs. 34 percent, respectively).

"This approval exemplifies Janssen's mission and commitment to bringing together passion, science and ingenuity to advance novel solutions for patients," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, LLC. "We are excited about the potential of this meaningful innovation in transforming the treatment experience for patients with multiple myeloma where DARZALEX FASPRO can be administered in approximately three to five minutes, significantly less time than intravenous DARZALEX, which is given over hours. Based on its favorable profile, we are accelerating the development of DARZALEX FASPRO and evaluating its potential in multiple ongoing studies."

Click to Tweet: #NEWS: #FDA approves subcutaneous CD38-directed antibody for the treatment of multiple #myeloma. See here for more details: https://bit.ly/2VozhzY

The approval is based on data from the Phase 3 COLUMBA (MMY3012)and Phase 2 PLEIADES (MMY2040) studies.1,2 In the COLUMBA study, the ORR was non-inferior for patients taking DARZALEX FASPROas monotherapycompared to those taking intravenous DARZALEXas monotherapy (41 percent vs. 37 percent, respectively). In addition, there were fewer systemic ARRs with DARZALEX FASPRO versus intravenous DARZALEX (13 percent vs. 34 percent, respectively). In a pooled safety population of 490 patients who received DARZALEXFASPRO as monotherapy or in combination, the ARR rate wFas 11 percent. The safety profiles of intravenous DARZALEX and DARZALEX FASPRO were otherwise similar.1 Additionally, in the Phase 2 PLEIADES study evaluating the efficacy and safety of DARZALEX FASPRO in combination therapies, objective responses were demonstrated in combination with bortezomib, melphalan and prednisone (D-VMP) in newly diagnosed transplant ineligible patients. In addition, objective responses were demonstrated in combination with lenalidomide and dexamethasone (D-Rd) in relapsed or refractory patients who received one prior line of therapy.2

"The Multiple Myeloma Research Foundation shares a common goal with Janssen in advancing treatments for multiple myeloma and addressing the unmet needs of this patient community," said Paul Giusti, President and CEO of the Multiple Myeloma Research Foundation (MMRF). "The approval of DARZALEXFASPRO marks an important milestone which will help make a positive difference in the lives of patients who depend on this effective therapy."

Click to Tweet: .@theMMRF talks about advancing treatments for multiple #myeloma and addressing patient needs with latest #FDA approval. Read more here: https://bit.ly/2VozhzY

"Since the approval of daratumumab, a robust body of evidence has established its use as a treatment for multiple myeloma in both the frontline and relapsed and refractory settings," said Saad Z. Usmani, M.D., Division Chief of Plasma Cell Disorders, Levine Cancer Institute. "With DARZALEX FASPRO there may be fewer administration-related reactions compared to intravenous DARZALEX, providing an additional treatment option that may help patients, oncologists and nursing staff."

DARZALEX FASPROis co-formulated with recombinant human hyaluronidase PH20 (rHuPH20) [Halozyme'sENHANZEdrug delivery technology].DARZALEX FASPRO will be available to patients and physicians as soon as the week of May 11, 2020. The intravenous DARZALEX formulation will also remain available as an option for patients and their physicians.

DARZALEX FASPROis approved in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant, in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy, in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy, as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.

The U.S. FDA approval of DARZALEX FASPRO marks the first approval for this innovative subcutaneous formulation globally, and Janssen continues to work with health authorities around the world in an effort to bring this new treatment option to patients living with multiple myeloma.

Access to DARZALEX FASPRO (daratumumab and hyaluronidase-fihj)Janssen offers comprehensive access and support information, resources and services to assist U.S. patients in gaining access to DARZALEX FASPROthrough the Janssen CarePath Program. Through the program, eligible commercial patients pay no more than $5 per injection, regardless of individual income level. Information on the enrollment process is available online atwww.CarePathSavingsProgram.com/DARZALEX.

For more information, healthcare providers or patients can contact: 1-844-55DARZA (1-844-553-2792). Information will also be available atwww.DARZALEX.com. Dedicated case coordinators are available to work with both healthcare providers and patients.

About the COLUMBA Study 1The randomized, open-label, multicenter Phase 3 COLUMBA study (MMY3012) included 522 patients (median age of 67 years) with multiple myeloma who had received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or whose disease was refractory to both a PI and an IMiD. In the arm that received DARZALEX FASPRO(n=263), patients received a fixed dose of DARZALEX FASPRO1,800 milligrams (mg), co-formulated with recombinant human hyaluronidase PH20 (rHuPH20) 2,000 Units per milliliter (U/mL), subcutaneously weekly for Cycles 1 2, every two weeks for Cycles 3 6 and every four weeks for Cycle 7 and thereafter. In the intravenous DARZALEXarm (n=259), patients received DARZALEXfor intravenous infusion 16 milligrams per kilogram (mg/kg) weekly for Cycles 1 2, every two weeks for Cycles 3 6 and every four weeks for Cycle 7 and thereafter. Each cycle was 28 days. In the arm that received DARZALEX FASPRO, itwas given in a fixed volume of 15 mL over three to five minutes; the median injection time was five minutes. In the arm that received theintravenous administration, the median durations of the first, second and subsequent intravenous DARZALEXinfusions were 7.0, 4.3 and 3.4 hours, respectively.Patients in both arms continued treatment until disease progression or unacceptable toxicity.

About the PLEIADES Study 2The non-randomized, open-label, parallel assignment Phase 2 PLEIADES study (MMY2040) included more than 240 adults with multiple myeloma, including 67 patients with newly diagnosed multiple myeloma who were treated with 1,800 mg of DARZALEX FASPROin combination with bortezomib, melphalan, and prednisone (D-VMP) and 65 patients with relapsed or refractory disease who were treated with 1,800 mg of DARZALEX FASPROplus lenalidomide and dexamethasone (D-Rd). The primary endpoint for the D-VMP and D-Rd cohorts was overall response rate.

About DARZALEXand DARZALEX FASPROJanssen is committed to exploring the potential of DARZALEX (daratumumab) for patients with multiple myeloma across the spectrum of the disease. DARZALEX has been approved in seven indications, three of which are in the frontline setting, including newly diagnosed patients who are transplant eligible and ineligible.

DARZALEX has become a backbone therapy in the treatment of multiple myeloma, having been used in the treatment of more than 58,000 patients in the U.S. alone since its U.S. FDA approval in 2015. DARZALEX is the first CD38-directed antibody approved globally to treat multiple myeloma and in 2020, DARZALEX FASPRO(daratumumab and hyaluronidase human-fihj) follows as the only subcutaneous CD38-directed antibody approved to treat patients with multiple myeloma.2

CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease.4 DARZALEX binds to CD38 and inhibits tumor cell growth causing myeloma cell death.5 DARZALEX may also have an effect on normal cells.3 Data across seven Phase 3 clinical trials, in both the frontline and relapsed settings, have shown that DARZALEX-based regimens resulted in significant improvement in progression-free survival and/or overall survival. 4,5,6,7,8,9,10,11 Additional studies are underway to assess the efficacy and safety of DARZALEXFASPRO in the treatment of other malignant and pre-malignant hematologic diseases in which CD38 is expressed, including smoldering myeloma and in amyloidosis.12,13

Key DARZALEX Milestones:

Please see full Prescribing Information at http://www.DARZALEX.com.

About Multiple MyelomaMultiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.21,22When damaged, these plasma cells rapidly spread and replace normal cells with tumors in the bone marrow. In 2020, it is estimated that 32,270 people will be diagnosed and 12,830 will die from the disease in the U.S.24 While some patients with multiple myeloma have no symptoms, most patients are diagnosed due to symptoms, which can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems or infections.23

Please see full Prescribing Information at http://www.DARZALEX.com.

About the Janssen Pharmaceutical Companies of Johnson & Johnson At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Learn more at http://www.janssen.com. Follow us at http://www.twitter.com/JanssenGlobal. Janssen Research & Development, LLC and Janssen Biotech, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

ENHANZEis a registered trademark of Halozyme.

1Mateos M-V et al. Efficacy and Safety of the Randomized, Open-Label, Non-inferiority, Phase 3 Study of Subcutaneous (SC) Versus Intravenous (IV) Daratumumab (DARA) Administration in Patients (pts) With Relapsed or Refractory Multiple Myeloma (RRMM): COLUMBA. 2019 American Society of Clinical Oncology Annual Meeting. June 2019.

2Janssen Research & Development, LLC. A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000 [cited July 5, 2019]. Available at: https://clinicaltrials.gov/ct2/show/NCT03412565. Identifier: NCT03412565.

32020Fedele G et al. CD38 Ligation in Peripheral Blood Mononuclear Cells of Myeloma Patients Induces Release of Protumorigenic IL-6 and Impaired Secretion of IFN Cytokines and Proliferation. Mediators Inflamm. 2013;564687.

4Janssen Research & Development, LLC. A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02076009?term=mmy3003&rank=1 Identifier: NCT02136134 .

5Janssen Research & Development, LLC. Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02136134?term=mmy3004&rank=1 Identifier: NCT02076009.

6Janssen Research & Development, LLC. A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma (Cassiopeia). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02541383?term=mmy3006 Identifier: NCT02541383.

7Janssen Research & Development, LLC. A Study of Combination of Daratumumab and Velcade (Bortezomib) Melphalan-Prednisone (DVMP) Compared to Velcade Melphalan-Prednisone (VMP) in Participants With Previously Untreated Multiple Myeloma In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02195479?term=mmy3007&rank=1 Identifier: NCT02195479.

8Janssen Research & Development, LLC. Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02252172?term=mmy3008&rank=1 Identifier: NCT02252172.

9Janssen Research & Development, LLC. A Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Participants With Previously Untreated Multiple Myeloma Who Are Ineligible for High-Dose Therapy (Asia Pacific Region). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT03217812?term=MMY3011&rank=1 Identifier: NCT03217812.

10European Myeloma Network. Compare Progression Free Survival Btw Daratumumab/Pomalidomide/Dexamethasone vs Pomalidomide/Dexamethasone (EMN14). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24] Available at: https://clinicaltrials.gov/ct2/show/NCT03180736?term=MMY3013&rank=2 Identifier: NCT03180736

11Amgen. Study of Carfilzomib, Daratumumab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma. (CANDOR). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24] Available at: https://clinicaltrials.gov/ct2/show/NCT03158688?term=NCT03158688&rank=1 Identifier: NCT03158688.

12Janssen Research & Development, LLC. A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants With Smoldering Multiple Myeloma In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 March 19]. Available at: https://clinicaltrials.gov/ct2/show/NCT02316106?term=smm2001&rank=1 Identifier: NCT02316106.

13Janssen Research & Development, LLC. An Efficacy and Safety Proof of Concept Study of Daratumumab in Relapsed/Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 March 19]. Available at: https://clinicaltrials.gov/ct2/show/NCT02413489?term=lym2001&rank=1 Identifier: NCT02413489

14Janssen Biotech, Inc. "Janssen Biotech Announces Global License and Development Agreement for Investigational Anti-Cancer Agent Daratumumab." Issued August 30, 2012.

15Janssen Biotech, Inc. "DARZALEX (daratumumab) Approved by U.S. FDA: First Human Anti-CD38 Monoclonal Antibody Available for the Treatment of Multiple Myeloma." Issued November 16, 2015.

16Janssen Biotech, Inc. "DARZALEX (daratumumab) Approved by U.S. FDA in Combination with Two Standard of Care Regimens for the Treatment of Patients with Multiple Myeloma Who Have Received At Least One Prior Therapy." Issued November 21, 2016.

17Janssen Biotech, Inc. "DARZALEX (daratumumab) Approved by the U.S. FDA in Combination with Pomalidomide and Dexamethasone for Patients with Multiple Myeloma Who Have Received At Least Two Prior Therapies." Issued June 16, 2017.

18Janssen Biotech, Inc. "Janssen Announces DARZALEX (daratumumab) U.S. FDA Approval for Newly Diagnosed Patients with Multiple Myeloma who are Transplant Ineligible." Issued May 7, 2018.

19Janssen Biotech, Inc. "Janssen Announces U.S. FDA Approval of DARZALEX (daratumumab) in Combination with Lenalidomide and Dexamethasone for Newly Diagnosed Patients with Multiple Myeloma Who Are Transplant Ineligible." Issued June 27, 2019.

20Janssen Biotech, Inc. "Janssen Announces U.S. FDA Approval of DARZALEX (daratumumab) Combination Regimen for Newly Diagnosed, Transplant-Eligible Patients with Multiple Myeloma." Issued September 26, 2019.

21Kumar, SK et al. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012 Jan; 26(1):149-57.

22American Cancer Society. "What Is Multiple Myeloma?" Available at: http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what-is-multiple-myeloma. Accessed June 2019.

23American Cancer Society. "Key Statistics About Multiple Myeloma." Available at: https://www.cancer.org/cancer/multiple-myeloma/about/key-statistics.html. Accessed January 2020.

SOURCE: Janssen

Link:
US Food and Drug Administration Approves DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a New Subcutaneous Formulation of Daratumumab in the...

Recommendation and review posted by Bethany Smith

Stem Cell Therapy market describes in-depth assessments and professional studies of the current and future status of the market worldwide, including valuable facts and figures. Stem Cell Therapy markets enhance this growth trend by providing information on new opportunities and market drivers, trends and future technologies. This report defines scope, coverage, production and CAGR (%) according to type, share, revenue status and outlook, capacity, consumption, market drivers, production status and outlook and opportunities, exports, imports, emerging market / national growth rates. This report provides a 360-degree overview of the industrys competitive environment. The Stem Cell Therapy market report evaluates key regions (countries) with a large market share during the forecast period.

Get sample copy of Stem Cell Therapy Market report @ https://www.adroitmarketresearch.com/contacts/request-sample/691

The research in its endeavor to present an unbiased presentation of the Stem Cell Therapy market, complete with multi-faceted documentation of various market forces that collectively lend enormous growth impetus to the Stem Cell Therapy market. This report further reinforces vital statistical data on technological marvels that under prevailing circumstances direct growth in the Stem Cell Therapy market. A holistic understanding on PESTEL and SWOT analysis are also tagged in the report to unearth peculiarities of the Stem Cell Therapy market.

Full Browse the report description and TOC: https://www.adroitmarketresearch.com/industry-reports/stem-cell-therapy-market

Furthermore, Report provides the deep analysis about the impact of domestic and global players on market, trade regulation, value chain optimization, and opportunities analysis for new present as well as new players, recent developments, strategic market growth analysis, area marketplace expanding, product launches, technological innovations and many more. The study report of global Stem Cell Therapy market can be split on the basis of key segments such as product type, application, key companies and key regions. Also the growth of the global Stem Cell Therapy market can be projected on the basis of segments and calculation for sales by application and type of the product in terms of volume and value.

Global Stem Cell Therapy market is segmented based by type, application and region.

Based on cell source, the market has been segmented into,

Adipose Tissue-Derived Mesenchymal SCsBone Marrow-Derived Mesenchymal SCsEmbryonic SCsOther Sources

Based on therapeutic application, the market has been segmented into,

Musculoskeletal DisordersWounds & InjuriesCardiovascular DiseasesGastrointestinal DiseasesImmune System DiseasesOther Applications

This market ready research offering on Stem Cell Therapy market is a go-to synopsis that highlights on all the core developments simultaneously dominant across all regional hubs in the Stem Cell Therapy market and their subsequent implications on holistic growth trajectory of Stem Cell Therapy market globally. The report is aimed at answering all the relevant queries pertaining to the target market based on which successful business decisions could be rapidly applied, favoring uncompromised growth in the Stem Cell Therapy market.

The report also lends light on competition spectrum, highlighting core market participants who are identified as frontline players in Stem Cell Therapy market as highlighted by this research. In its bid to equip players with real time understanding of the various operational factors dominant across regions, the research elaborating on Stem Cell Therapy market also houses crucial data on various geographical hubs identified in Stem Cell Therapys market as presented.

Do You Have Any Query Or Specific Requirement? Ask to Our Industry Expert @ https://www.adroitmarketresearch.com/contacts/enquiry-before-buying/691

About Us :

Adroit Market Research is an India-based business analytics and consulting company incorporated in 2018. Our target audience is a wide range of corporations, manufacturing companies, product/technology development institutions and industry associations that require understanding of a markets size, key trends, participants and future outlook of an industry. We intend to become our clients knowledge partner and provide them with valuable market insights to help create opportunities that increase their revenues. We follow a code- Explore, Learn and Transform. At our core, we are curious people who love to identify and understand industry patterns, create an insightful study around our findings and churn out money-making roadmaps.

Contact Us :

Ryan JohnsonAccount Manager Global3131 McKinney Ave Ste 600, Dallas,TX 75204, U.S.APhone No.: USA: +1 972-362 -8199 / +91 9665341414

Read more:
Global Stem Cell Therapy Market 2020: Growth, Demand, Service, Types, Applications, Key Players and Industry Forecast till 2025 - Latest Herald

Recommendation and review posted by Bethany Smith

Thursday, May 7, 2020, 8:30 a.m. EDT

NEW YORK, April 29, 2020 (GLOBE NEWSWIRE) -- BrainStorm-Cell Therapeutics Inc.(NASDAQ: BCLI), a leader in developing innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, announced today, that the Company will hold a conference call to update shareholders on financial results for the first quarter endedMarch 31, 2020, and provide a corporate update, at 8:30 a.m, Eastern Daylight Time, onThursday, May 7, 2020.

BrainStorms CEO,Chaim Lebovits, will present a corporate update, after which, participant questions will be answered. Joining Mr. Lebovits to answer investment community questions will beRalph Kern, MD, MHSc, President and Chief Medical Officer, David Setboun, PhD, MBA, Executive Vice President and Chief Operating Officer andPreetam Shah, PhD, MBA, Executive Vice President and Chief Financial Officer.

Participants are encouraged to submit their questions prior to the call by sending them to:q@brainstorm-cell.com. Questions should be submitted by5:00 p.m. EDT, Tuesday, May 5, 2020.

Teleconference Details BRAINSTORM CELL THERAPEUTICS 1Q 2020

The investment community may participate in the conference call by dialing the following numbers:

Those interested in listening to the conference call live via the internet may do so by visiting the "Investors & Media" page of BrainStorm's website at http://www.ir.brainstorm-cell.com and clicking on the conference call link.

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available for 14 days.

ABOUT NUROWNNurOwn (autologous MSC-NTF cells) represent a promising investigational approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. NurOwn is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS.

ABOUT BRAINSTORM CELL THERAPEUTICS INC.:BrainStorm Cell Therapeutics Inc.is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwnCellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. Autologous MSC-NTF cells have received Orphan Drug status designation from theU.S. Food and Drug Administration(U.S.FDA) and theEuropean Medicines Agency(EMA) in ALS. BrainStorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in theU.S., supported by a grant from theCalifornia Institute for Regenerative Medicine(CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S.FDAapproval of autologous MSC-NTF cells in ALS. BrainStorm received U.S.FDAclearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) inDecember 2018and has been enrolling clinical trial participants sinceMarch 2019. For more information, visit the company'swebsite.

SAFE HARBOR STATEMENT:Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could causeBrainStorm Cell Therapeutics Inc.'sactual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorms need to raise additional capital, BrainStorms ability to continue as a going concern, regulatory approval of BrainStorms NurOwn treatment candidate, the success of BrainStorms product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorms NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorms ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorms ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available athttp://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Story continues

More:
BrainStorm-Cell Therapeutics to Announce First Quarter Financial Results and Provide a Corporate Update - Yahoo Finance

Recommendation and review posted by Bethany Smith

MILAN, Italy--(BUSINESS WIRE)--Genespire, a biotechnology company focused on the development of transformative gene therapies for patients affected by genetic diseases, announced today the successful close of a 16M Series A financing from Sofinnova Partners, a leading European life sciences venture capital firm based in Paris, London and Milan. The company also announced the appointment of Julia Berretta, Ph.D., as Chief Executive Officer and member of the Board of Directors. Graziano Seghezzi, Managing Partner at Sofinnova Partners, and Lucia Faccio, Ph.D., Partner at Sofinnova Partners, will also join the Board.

Genespire was founded in March 2020 as a spin-off of the San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget), one of the worlds leading cell and gene therapy research institutes spearheaded by gene therapy pioneer Prof. Luigi Naldini. The Company was co-founded by Fondazione Telethon and the San Raffaele Hospital, along with Prof. Naldini and Dr. Alessio Cantore.

The funds will be used to advance Genespires leading-edge platform technologies towards the development of novel gene therapies in two main areas: primary immunodeficiencies and metabolic genetic diseases.

Our mission has always been to develop breakthrough solutions for genetic diseases, said Prof. Naldini, Genespires co-founder and Director of SR-Tiget. This financing enables the company to translate our innovative science and early stage programs into clinical development. The appointment of Dr. Berretta as CEO is a major reinforcement of our team.

Sofinnova Partners Dr. Faccio added, Genespire is an exciting investment with all the key ingredients for success: Outstanding scientists that developed the first ex-vivo gene therapy to market, experienced executives brought in through Sofinnova Partners network and game changing technologies that have the potential to impact the lives of patients with genetic diseases.

I am thrilled to be joining Genespire and such exceptional scientific founders, said Dr. Berretta. Genespire was born of decades of experience in the gene therapy field, and is optimally positioned to advance transformative therapies for patients affected by severe inherited diseases.

Dr. Berretta was part of the Executive Committee of Cellectis S.A., a Nasdaq-listed clinical stage gene editing company developing CAR-T cell therapies for cancer, where she led business development as well as strategic planning. She is also an independent Board member of Treefrog Therapeutics, an innovative stem cell company.

About Genespire

Genespire is a biotechnology company focused on the development of transformative gene therapies for patients affected by genetic diseases, particularly primary immunodeficiencies and inherited metabolic diseases. Based in Milan, Italy, Genespire was founded in March 2020 by the gene therapy pioneer Prof. Luigi Naldini, Dr. Alessio Cantore, Fondazione Telethon and Ospedale San Raffaele. It is a spin-off of SR-Tiget, a world leading cell and gene therapy research institute and is backed by Sofinnova Partners. http://www.genespire.com

About Sofinnova Partners

Sofinnova Partners is a leading European venture capital firm specialized in Life Sciences. Based in Paris, France, with offices in London and Milan, the firm brings together a team of 40 professionals from all over Europe, the U.S. and Asia. The firm focuses on paradigm-shifting technologies alongside visionary entrepreneurs. Sofinnova Partners invests across the Life Sciences value chain as a lead or cornerstone investor, from very early-stage opportunities to late-stage/public companies. It has backed nearly 500 companies over more than 48 years, creating market leaders around the globe. Today, Sofinnova Partners has over 2 billion under management.

For more information, please visit: http://www.sofinnovapartners.com

About Fondazione Telethon

Fondazione Telethon is a non-profit organisation created in 1990 as a response to the appeals of a patient association group of stakeholders, who saw scientific research as the only real opportunity to effectively fight genetic diseases. Thanks to the funds raised through the television marathon, along with other initiatives and a network of partners and volunteers, Telethon finances the best scientific research on rare genetic diseases, evaluated and selected by independent internationally renowned experts, with the ultimate objective of making the treatments developed available to everyone who needs them. Throughout its 30 years of activity, Fondazione Telethon has invested more than 528 million in funding more than 2.630 projects to study more than 570 diseases, involving over 1.600 scientists. Fondazione Telethon has made a significant contribution to the worldwide advancement of knowledge regarding rare genetic diseases and of academic research and drug development with a view to developing treatments. For more information, please visit: http://www.telethon.it

About Ospedale San Raffaele

Ospedale San Raffaele (OSR) is a clinical-research-university hospital established in 1971 to provide international-level specialised care for the most complex and difficult health conditions. OSR is part of Gruppo San Donato, the leading hospital group in Italy. The hospital is a multi-specialty center with over 60 clinical specialties; it is accredited by the Italian National Health System to provide care to both public and private, national and international patients. Research at OSR focuses on integrating basic, translational and clinical activities to provide the most advanced care to our patients. The institute is recognized as a global authority in molecular medicine and gene therapy, and is at the forefront of research in many other fields. Ospedale San Raffaele is a first-class institute which treats many diseases and stands out for the deep interaction between clinical and scientific area. This makes the transfer of scientific results from the laboratories to the patients bed easier. Its mission is to improve knowledge of diseases, identify new therapies and encourage young scientists and doctor to grow professionally. For more information, please visit: http://www.hsr.it

About the San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget)

Based in Milan, Italy, the San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget) is a joint venture between the Ospedale San Raffaele and Fondazione Telethon. SR-Tiget was established in 1995 to perform research on gene transfer and cell transplantation and translate its results into clinical applications of gene and cell therapies for different genetic diseases.

See the original post:
Genespire Secures 16 Million Series A Financing from Sofinnova Partners to Advance Transformative Gene Therapies - Business Wire

Recommendation and review posted by Bethany Smith

DUBLIN, April 30, 2020 /PRNewswire/ -- The "SRP-9001 - Emerging Insight and Market Forecast - 2030" report has been added to ResearchAndMarkets.com's offering.

The report provides comprehensive insights about an investigational product for Duchene muscular dystrophy (DMD) in 7 Major Markets.

A detailed picture of the SRP-9001 in Seven Major Markets, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan, for the study period 2020-2030 is provided in this report along with a detailed description of the product.

The product details cover mechanism of action, dosage and administration, route of synthesis, and research and development activity including regulatory milestones, and other development activities. Further, it also consists of future market assessments inclusive of the market forecast, SWOT analysis, market competitors, and other emerging therapies.

Overview

SRP-9001 is being developed by Sarepta Therapeutics which is currently in Phase II clinical development for the treatment of Duchenne muscular dystrophy. It is designed to deliver the micro-dystrophin-encoding gene directly to the muscle tissue for the targeted production of the micro-dystrophin protein. Roche has acquired exclusive commercial rights outside the United States to Sarepta Therapeutics' lead gene therapy pipeline candidate SRP-9001 for Duchenne muscular dystrophy (DMD).

The report provides insights into:

Report Highlights

Key Questions Answered

Key Topics Covered

1. Drug Overview1.1. Product Detail1.2. Mechanism of Action1.3. Dosage and Administration1.4. Research and Development Activity1.4.1. Clinical Development1.4.2. Safety and Efficacy1.5. Other Development Activities

2. Market Assessment2.1. 7MM Market Analysis2.2. The United States Market2.3. Germany Market2.4. France Market2.5. Italy Market2.6. Spain Market2.7. United Kingdom Market2.8. Japan Market

3. SWOT Analysis

4. Analyst Views

5. Market Competitors

6. Other Emerging Therapies

List of TablesTable 1 SRP-9001, DescriptionTable 2 SRP-9001, Clinical Trial DescriptionTable 3 SRP-9001, 7MM Market Size from 2020 to 2030 (in Million USD)Table 4 Market CompetitorsTable 5 Other Emerging Therapies

List of FiguresFigure 1 The Development Timeline of SRP-9001 Figure 2 Patent Details, SRP-9001 Figure 3 SRP-9001, 7MM Market Size from 2020 to 2030 (in Million USD)Figure 4 SRP-9001, US Market Size from 2020 to 2030 (in Millions USD)Figure 5 SRP-9001, EU5 Market Size from 2020 to 2030 (in Millions USD)Figure 6 SRP-9001, Japan Market Size from 2020 to 2030 (in Millions USD)

For more information about this report visit https://www.researchandmarkets.com/r/5p03nc

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

Media Contact:

Research and Markets Laura Wood, Senior Manager press@researchandmarkets.com

For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716

View original content:http://www.prnewswire.com/news-releases/srp-9001-sarepta-therapeutics-emerging-insights-and-market-forecast-to-2030-301050426.html

SOURCE Research and Markets

More here:
SRP-9001 [Sarepta Therapeutics] Emerging Insights and Market Forecast to 2030 - P&T Community

Recommendation and review posted by Bethany Smith

The Gene Therapy for Ovarian Cancer report provides independent information about the Gene Therapy for Ovarian Cancer industry supported by extensive research on factors such as industry segments size & trends, inhibitors, dynamics, drivers, opportunities & challenges, environment & policy, cost overview, porters five force analysis, and key companies profiles including business overview and recent development.

Gene Therapy for Ovarian Cancer MarketLatest Research Report 2020:

Download Premium Sample Copy Of This Report: Download FREE Sample PDF!

In this report, our team offers a thorough investigation of Gene Therapy for Ovarian Cancer Market, SWOT examination of the most prominent players right now. Alongside an industrial chain, market measurements regarding revenue, sales, value, capacity, regional market examination, section insightful information, and market forecast are offered in the full investigation, and so forth.

Scope of Gene Therapy for Ovarian Cancer Market: Products in the Gene Therapy for Ovarian Cancer classification furnish clients with assets to get ready for tests, tests, and evaluations.

Major Company Profiles Covered in This Report

Takara Bio, VBL Therapeutics, CELSION, Targovax

Gene Therapy for Ovarian Cancer Market Report Covers the Following Segments:

Segment by Type:

IntravenousIntratumoralIntraperitoneal

Segment by Application:

Ovarian Cancer (unspecified)Recurrent Ovarian Epithelial CancerPlatinum-Resistant Ovarian Cancer

North America

Europe

Asia-Pacific

South America

Center East and Africa

United States, Canada and Mexico

Germany, France, UK, Russia and Italy

China, Japan, Korea, India and Southeast Asia

Brazil, Argentina, Colombia

Saudi Arabia, UAE, Egypt, Nigeria and South Africa

Market Overview:The report begins with this section where product overview and highlights of product and application segments of the global Gene Therapy for Ovarian Cancer Market are provided. Highlights of the segmentation study include price, revenue, sales, sales growth rate, and market share by product.

Competition by Company:Here, the competition in the Worldwide Gene Therapy for Ovarian Cancer Market is analyzed, By price, revenue, sales, and market share by company, market rate, competitive situations Landscape, and latest trends, merger, expansion, acquisition, and market shares of top companies.

Company Profiles and Sales Data:As the name suggests, this section gives the sales data of key players of the global Gene Therapy for Ovarian Cancer Market as well as some useful information on their business. It talks about the gross margin, price, revenue, products, and their specifications, type, applications, competitors, manufacturing base, and the main business of key players operating in the global Gene Therapy for Ovarian Cancer Market.

Market Status and Outlook by Region:In this section, the report discusses about gross margin, sales, revenue, production, market share, CAGR, and market size by region. Here, the global Gene Therapy for Ovarian Cancer Market is deeply analyzed on the basis of regions and countries such as North America, Europe, China, India, Japan, and the MEA.

Application or End User:This section of the research study shows how different end-user/application segments contribute to the global Gene Therapy for Ovarian Cancer Market.

Market Forecast:Here, the report offers a complete forecast of the global Gene Therapy for Ovarian Cancer Market by product, application, and region. It also offers global sales and revenue forecast for all years of the forecast period.

Research Findings and Conclusion:This is one of the last sections of the report where the findings of the analysts and the conclusion of the research study are provided.

About Us:

We publish market research reports & business insights produced by highly qualified and experienced industry analysts. Our research reports are available in a wide range of industry verticals including aviation, food & beverage, healthcare, ICT, Construction, Chemicals and lot more. Brand Essence Market Research report will be best fit for senior executives, business development managers, marketing managers, consultants, CEOs, CIOs, COOs, and Directors, governments, agencies, organizations and Ph.D. Students.

Top Trending Reports:

https://industrystatsreport.com/Lifesciences-and-Healthcare/Dynamic-Rsearch-on-Biotechnology-Reagents-Market/Summary

https://industrystatsreport.com/Lifesciences-and-Healthcare/Dynamic-Rsearch-on-Scoliosis-Treatment-Market/Summary

https://industrystatsreport.com/Lifesciences-and-Healthcare/Dynamic-Rsearch-on-Biotechnology-Reagents-Market/Summary

The rest is here:
Cover Corona Outbreak: Gene Therapy for Ovarian Cancer Market Size Analysis and Growth (2020-2025) - Cole of Duty

Recommendation and review posted by Bethany Smith

A cancer researcher at the University of Alberta and his team are breathing new life into a promising cancer therapy by improving how the treatment is delivered.

Hasan Uludag, a professor in chemical and materials engineering, and his team have developed a chemical compound that allows them to effectively inject genetic material into cells.

The compound, a lipopolymer, prompts the cells to begin producing a proteintumour necrosis factor-related apoptosis-inducing ligand (TRAIL)that has been proven to kill tumour cells effectively.

The TRAIL protein has been used in treatment but led to many side-effects. The addition of the compound, which uses the positive cancer-killing aspect of the TRAIL protein, eliminates the side-effects.

When you have this combination (of the protein and the compound), the cells are ready, they are primed for the action of this protein, so when they see TRAIL they display this high potency and they die much more easily, said Uludag.

With the new delivery method, Uludag, a member of the Cancer Research Institute of Northern Alberta, also addressed the issue of cell resistance in TRAIL therapy.

Though the treatment was somewhat effective with previous delivery methods, about 10 per cent of cancerous cells survived and eventually developed resistance to the treatment. With the new lipopolymer delivery method, researchers can find alternate targets within the cell and break that resistance, killing the remainder of tumour cells.

The new approach also holds possibilities for individualized therapeutics. Common therapeutics used today are not customizable, and though things like dosage can be changed as appropriate, ultimately, if the cells resist a drug or it proves ineffective, there is no option but to completely switch the drug and try another treatment. With an approach that uses genetic materials, alterations can be made to the order of materials in the DNA strand, known as the nucleotide sequence, to target different proteins.

The nature of the drug stays the same, the delivery, the application stays the same, you just change the siRNA, said Uludag. In terms of tailoring the therapy for patients, what we are proposing is much more possible to personalize compared to conventional ways for treating cancer patients.

The next steps in this co-delivery approach are to reproduce the studies on a larger scale and do a parallel set of studies to specifically examine whether the new therapeutic is safe, not just whether it works.

Different genetic material combinations could be used to target different types of breast cancer cells as well as other types of cancer.

Some of the old drugs we gave up, I think, are promising and might provide us with new ways to combat cancer, Uludag said.

Uludags spinoff company, RJH Biosciences, recently received a $100,000 grant from the Bill and Melinda Gates Foundation for a related project exploring how to better deliver therapeutics to target blood cancer by developing particular delivery systems.

The study, Breathing New Life into TRAIL for Breast Cancer Therapy: Co-Delivery of pTRAIL and Complementary siRNAs Using Lipopolymers, was published in Human Gene Therapy.

Originally posted here:
Cancer researchers find more effective way to deliver promising breast cancer treatment - Folio - University of Alberta

Recommendation and review posted by Bethany Smith

The research report on Gene Therapy Market provides comprehensive analysis on market status and development pattern, including types, applications, rising technology and region. Gene Therapy Market report covers the present and past market scenarios, market development patterns, and is likely to proceed with a continuing development over the forecast period. The report covers all information on the global and regional markets including historic and future trends for market demand, size, trading, supply, competitors, and prices as well as global predominant vendors information.

Get Sample copy: https://www.reportspedia.com/report/life-sciences/global-gene-therapy-market-research-report-2014-2026-of-major-types,-applications-and-competitive-vendors-in-top-regions-and-countries/44997 #request_sample

This market research report on the Gene Therapy Market is an all-inclusive study of the business sectors up-to-date outlines, industry enhancement drivers, and manacles. It provides market projections for the coming years. It contains an analysis of late augmentations in innovation, Porters five force model analysis and progressive profiles of hand-picked industry competitors. The report additionally formulates a survey of minor and full-scale factors charging for the new applicants in the market and the ones as of now in the market along with a systematic value chain exploration.

An outline of the manufacturers active within the Gene Therapy Market, consisting of

Sibiono GeneTech,Advantagene,Spark Therapeutics,Shanghai Sunway Biotech Co. LtdBluebird Bio,UniQure NVAvalanche Bio,Celladon,Sangamo,Dimension Therapeutics

The Gene Therapy Market Segmentation by Type:

Viral vectorNon-viral vector

The Gene Therapy Market Segmentation by Application:

Oncological DisordersRare DiseasesCardiovascular DiseasesNeurological DisordersInfectious diseaseOther Diseases

Market Segment by Regions, regional analysis covers

Get Upto 40% discount on this report Click Here @ https://www.reportspedia.com/discount_inquiry/discount/ 44997

The competitive landscape of the Gene Therapy Market is discussed in the report, including the market share and new orders market share by company. The report profiles some of the leading players in the global market for the purpose of an in-depth study of the challenges faced by the industry as well as the growth opportunities in the market. The report also discusses the strategies implemented by the key companies to maintain their hold on the industry. The business overview and financial overview of each of the companies have been analyzed.

This report provide wide-ranging analysis of the impact of these advancements on the markets future growth, wide-ranging analysis of these extensions on the markets future growth. The research report studies the market in a detailed manner by explaining the key facets of the market that are foreseeable to have a countable stimulus on its developing extrapolations over the forecast period.

Key questions answered in this research report:

Table of Contents:

Global Gene Therapy Market Research Report

Chapter 1 Gene Therapy Market Overview

Chapter 2 Global Economic Impact on Industry

Chapter 3 Global Market Competition by Manufacturers

Chapter 4 Global Production, Revenue (Value) by Region

Chapter 5 Global Supply (Production), Consumption, Export, Import by Regions

Chapter 6 Global Production, Revenue (Value), Price Trend by Type

Chapter 7 Global Market Analysis by Application

Chapter 8 Manufacturing Cost Analysis

.CONTINUED FOR TOC

Get Full Table of content @ https://www.reportspedia.com/report/life-sciences/global-gene-therapy-market-research-report-2014-2026-of-major-types,-applications-and-competitive-vendors-in-top-regions-and-countries/44997 #table_of_contents

If you have any special requirements, please let us know and we will offer you the report as you want.

More here:
Global Gene Therapy Market Size, Share, Growth, Revenue, Global Industry Analysis and Future Demand And Forecast To 2020-2026 Cole Reports - Cole of...

Recommendation and review posted by Bethany Smith

R.A. Session II, president, CEO, and founder of Taysha Gene Therapies [Background image: Olena Yepifanova via iStock]

Dallas-based biotech Taysha Gene Therapies has emerged out of stealth with a $30 million seed round and a new strategic partnership with UT Southwestern. The company aims to end severe and life-threatening diseases of the central nervous system caused by variation in a single gene, also known as monogenic CNS diseases.

Hitting the ground running, the company launches with a pipeline of 15 adeno-associated virus gene therapy programs, along with options to four others.

Taysha plans human testing this year and expects to file four Initial New Drug applications in 2021. In addition, the biotech is developing an improved treatment delivery platform that uses machine learning, DNA shuffling, and something it calls directed evolution.

The gene therapy startup closed its round of seed financing in early March just as the Dow dropped a couple of thousand points, according to a report in EndpointsNews.

If you had to ask me, was I worried? Absolutely. I think I wouldnt be human if I wasnt, RA Session II, president, CEO, and founder of Taysha, told the healthcare publication.

Session had a lot of certainty to balance out all the uncertainty of launching a new biotech during a pandemic, noted Endpoints Amber Tong.

The experience of a proven management team, including some who previously led the development and commercialization of the first FDA-approved gene therapy for CNS disease, Zolgensma, is part of the equation.

The startup intends to combine the speed, scale, and expertise of its partners UT Southwestern Gene Therapy Program with the experience of the Taysha team.

Session says the launch reunites former investors and executives from AveXis. Tayshas funding round was co-led by PBM Capital, the first institutional investor in AveXis, and Nolan Capital, the investment fund of former AveXis CEO Sean Nolan.

Tayshas Board of Directors played a key role in the formation of the company, it said. The board is comprised of Sean Nolan, Paul Manning of PBM Capital, Claire Aldridge, Ph.D., of UT Southwestern, and RA Session II, President, CEO, and Founder of Taysha.

Nolan, who serves as Chairman of the Board, sees promise in Tayshas approach for patients suffering from many devastating CNS diseases.

This is an exciting time for gene therapy, he said.

The strategic partnership with UT Southwestern could help Taysha to rapidly and efficiently translate novel AAV gene therapies from bench to bedside, the company said.

UTSW is home to some of the brightest minds in gene therapy, Sessions says. By joining forces with UT Southwestern, Taysha can advance its potential cures with both speed and scale.

The collaboration is ultimately creating an engine for new cures, said Claire Aldridge, Ph.D., a Taysha board member and associate vice president of commercialization and business development at UT Southwestern Medical Center.

Together, Taysha and UTSW will merge cutting-edge translational research, hands-on clinical care, and expertiseboth regulatory and commercial, she said.

Aldridge has already witnessed how quickly and efficiently the partners can leverage their collective expertise and resources. That means getting new gene therapies to the patients who so desperately need them, she said.

The UT Southwestern Gene Therapy Program, led by Steven Gray, Ph.D., Director of the Viral Vector Core and Assistant Professor in the Department of Pediatrics, and Berge Minassian, M.D., Division Chief of Child Neurology, has the capacity to support Tayshas wide range of preclinical and clinical development programs, the company said.

Under the partnership, UT Southwestern, which has developed a state-of-the-art viral vector manufacturing facility, will run discovery and preclinical research, as well as lead studies, provide manufacturing, and execute natural history studies.

For its part, Taysha will lead all clinical development, regulatory strategy, commercial manufacturing, and commercialization activities, according to the company.

A joint steering committee of key leadership members from Taysha and UT Southwestern will govern the collaboration.

Sign up to keep your eye on whats new and next in Dallas-Fort Worth, every day.

The free, five-day celebration of all things startup is officially underway.

Browse our curated selection of events to plan your next week and beyond.

Friday morning's Startup Week activities led off with a women's networking breakfast and a Creative Mornings event. Then, sessions have covered equity in real estate, corporate innovation, fundraising, and the future of philanthropy.

Thursday led off with a session delving into blockchain's use in health care and events giving tips in SEO, influencer marketing, and legal issues.RevTech also hosted its signature Tech Trends in Retail event.

Wednesday's panels have tackled disruptive technologies such as blockchain, the corporate-startup relationship, and more.

See original here:
Dallas Gene Therapy Startup Launches with $30M Seed Round and a UT Southwestern Partnership - dallasinnovates.com

Recommendation and review posted by Bethany Smith

Documenting the Industry Development of Gene Therapy Market concentrating on the industry that holds a massive market share 2020 both concerning volume and value With top countries data, Manufacturers, Suppliers, In-depth research on market dynamics, export research report and forecast to 2029

As per the report, the Gene Therapy Market is anticipated to gain substantial returns while registering a profitable annual growth rate during the predicted time period.The global gene therapy market research report takes a chapter-wise approach in explaining the dynamics and trends in the gene therapy industry.The report also provides the industry growth with CAGR in the forecast to 2029.

A deep analysis of microeconomic and macroeconomic factors affecting the growth of the market are also discussed in this report. The report includes information related to On-going demand and supply forecast. It gives a wide stage offering numerous open doors for different businesses, firms, associations, and start-ups and also contains authenticate estimations to grow universally by contending among themselves and giving better and agreeable administrations to the clients. In-depth future innovations of gene therapy Market with SWOT analysis on the basis Of type, application, region to understand the Strength, Weaknesses, Opportunities, and threats in front of the businesses.

Get a Sample Report for More Insightful Information(Use official eMail ID to Get Higher Priority):https://market.us/report/gene-therapy-market/request-sample/

***[Note: Our Complimentary Sample Report Accommodate a Brief Introduction To The Synopsis, TOC, List of Tables and Figures, Competitive Landscape and Geographic Segmentation, Innovation and Future Developments Based on Research Methodology are also Included]

An Evaluation of the Gene Therapy Market:

The report is a detailed competitive outlook including the Gene Therapy Market updates, future growth, business prospects, forthcoming developments and future investments by forecast to 2029. The region-wise analysis of gene therapy market is done in the report that covers revenue, volume, size, value, and such valuable data. The report mentions a brief overview of the manufacturer base of this industry, which is comprised of companies such as- Bluebird Bio, Sangamo, Spark Therapeutics, Dimension Therapeutics, Avalanche Bio, Celladon, Vical Inc, Advantagene.

Segmentation Overview:

Product Type Segmentation :

Ex vivo, In Vivo

Application Segmentation :

Cancer, Monogenic, Infectious disease, Cardiovascular disease

To know more about how the report uncovers exhaustive insights |Enquire Here: https://market.us/report/gene-therapy-market/#inquiry

Key Highlights of the Gene Therapy Market:

The fundamental details related to Gene Therapy industry like the product definition, product segmentation, price, a variety of statements, demand and supply statistics are covered in this article.

The comprehensive study of gene therapy market based on development opportunities, growth restraining factors and the probability of investment will anticipate the market growth.

The study of emerging Gene Therapy market segments and the existing market segments will help the readers in preparing the marketing strategies.

The study presents major market drivers that will augment the gene therapy market commercialization landscape.

The study performs a complete analysis of these propellers that will impact the profit matrix of this industry positively.

The study exhibits information about the pivotal challenges restraining market expansion

The market review for the global market is done in context to region, share, and size.

The important tactics of top players in the market.

Other points comprised in the Gene Therapy report are driving factors, limiting factors, new upcoming opportunities, encountered challenges, technological advancements, flourishing segments, and major trends of the market.

Check Table of Contents of This Report @https://market.us/report/gene-therapy-market//#toc

Get in Touch with Us :

Mr. Benni Johnson

Market.us (Powered By Prudour Pvt. Ltd.)

Send Email:[emailprotected]

Address:420 Lexington Avenue, Suite 300 New York City, NY 10170, United States

Tel:+1 718 618 4351

Website:https://market.us

Our Trending Blog:https://foodnbeveragesmarket.com/

Get More News From Other Reputed Sources:

Temporary Pacemaker Market Attractiveness, Competitive Landscape, Traders/Distributors, Key Buyers, Forecasts 2020-2029 | BioSpace

Thymol Market Economic Forecasting By Key Players 2029 | J & K SCIENTIFIC and Meryer (Shanghai) Chemical Technology

Continued here:
Gene Therapy Market | on(impact of COVID-19) 2020-2029 Analysis on Growth, Future Demand 2020 - Jewish Life News

Recommendation and review posted by Bethany Smith

Complete study of the global Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing market is carried out by the analysts in this report, taking into consideration key factors like drivers, challenges, recent trends, opportunities, advancements, and competitive landscape. This report offers a clear understanding of the present as well as future scenario of the global Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing industry. Research techniques like PESTLE and Porters Five Forces analysis have been deployed by the researchers. They have also provided accurate data on Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing production, capacity, price, cost, margin, and revenue to help the players gain a clear understanding into the overall existing and future market situation.

Key companies operating in the global Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing market include , BioReliance, Cobra Biologics, Oxford BioMedica, UniQure, FinVector, MolMed, MassBiologics, Richter-Helm, FUJIFILM Diosynth Biotechnologies, Lonza, Aldevron, Eurogentec, Cell and Gene Therapy Catapult, Biovian, Brammer Bio, VGXI, PlasmidFactory, bluebird bio, Novasep, Spark Therapeutics, Vigene Biosciences Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing

Get PDF Sample Copy of the Report to understand the structure of the complete report: (Including Full TOC, List of Tables & Figures, Chart) :

https://www.qyresearch.com/sample-form/form/1688742/covid-19-impact-on-global-viral-vectors-non-viral-vectors-and-gene-therapy-manufacturing-market

Segmental Analysis

The report has classified the global Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing industry into segments including product type and application. Every segment is evaluated based on growth rate and share. Besides, the analysts have studied the potential regions that may prove rewarding for the Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing manufcaturers in the coming years. The regional analysis includes reliable predictions on value and volume, thereby helping market players to gain deep insights into the overall Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing industry.

Global Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market Segment By Type:

, AAV, Adenoviral, Lentiviral, Retroviral, Plasmid DNA, Other Vectors Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing

Global Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market Segment By Application:

, Cancers, Inherited Disorders, Viral Infections, Others

Competitive Landscape

It is important for every market participant to be familiar with the competitive scenario in the global Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing industry. In order to fulfil the requirements, the industry analysts have evaluated the strategic activities of the competitors to help the key players strengthen their foothold in the market and increase their competitiveness.

Key companies operating in the global Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing market include , BioReliance, Cobra Biologics, Oxford BioMedica, UniQure, FinVector, MolMed, MassBiologics, Richter-Helm, FUJIFILM Diosynth Biotechnologies, Lonza, Aldevron, Eurogentec, Cell and Gene Therapy Catapult, Biovian, Brammer Bio, VGXI, PlasmidFactory, bluebird bio, Novasep, Spark Therapeutics, Vigene Biosciences Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing

Key questions answered in the report:

Get Full Report in your inbox within 24 hours at USD(3900)

https://www.qyresearch.com/settlement/pre/883b2a7084e9a78c35e4a8ccb9e4e87d,0,1,covid-19-impact-on-global-viral-vectors-non-viral-vectors-and-gene-therapy-manufacturing-market

TOC

1 Report Overview1.1 Study Scope1.2 Key Market Segments1.3 Players Covered: Ranking by Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Revenue1.4 Covid-19 Implications on Market by Type1.4.1 Global Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market Size Growth Rate by Type: 2020 VS 20261.4.2 AAV1.4.3 Adenoviral1.4.4 Lentiviral1.4.5 Retroviral1.4.6 Plasmid DNA1.4.7 Other Vectors1.5 Covid-19 Implications on Market by Application1.5.1 Global Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market Share by Application: 2020 VS 20261.5.2 Cancers1.5.3 Inherited Disorders1.5.4 Viral Infections1.5.5 Others1.6 Coronavirus Disease 2019 (Covid-19): Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Industry Impact1.6.1 How the Covid-19 is Affecting the Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Industry1.6.1.1 Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Business Impact Assessment Covid-191.6.1.2 Supply Chain Challenges1.6.1.3 COVID-19s Impact On Crude Oil and Refined Products1.6.2 Market Trends and Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Potential Opportunities in the COVID-19 Landscape1.6.3 Measures / Proposal against Covid-191.6.3.1 Government Measures to Combat Covid-19 Impact1.6.3.2 Proposal for Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Players to Combat Covid-19 Impact 1.7 Study Objectives 1.8 Years Considered2 Global Growth Trends by Regions2.1 Covid-19 Implications on Global Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market Perspective (2015-2026)2.2 Covid-19 Implications on Global Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Growth Trends by Regions2.2.1 Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market Size by Regions: 2015 VS 2020 VS 20262.2.2 Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Historic Market Share by Regions (2015-2020)2.2.3 Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Forecasted Market Size by Regions (2021-2026) 2.3 Industry Trends and Growth Strategy 2.3.1 Market Top Trends 2.3.2 Market Drivers2.3.3 Market Challenges2.3.4 Porters Five Forces Analysis2.3.5 Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market Growth Strategy2.3.6 Primary Interviews with Key Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Players (Opinion Leaders)3 Covid-19 Implications on Competition Landscape by Key Players3.1 Global Top Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Players by Market Size3.1.1 Global Top Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Players by Revenue (2015-2020)3.1.2 Global Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Revenue Market Share by Players (2015-2020)3.1.3 Global Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market Share by Company Type (Tier 1, Tier 2 and Tier 3)3.2 Global Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market Concentration Ratio3.2.1 Global Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market Concentration Ratio (CR5 and HHI)3.2.2 Global Top 10 and Top 5 Companies by Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Revenue in 20193.3 Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Key Players Head office and Area Served3.4 Key Players Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Product Solution and Service3.5 Date of Enter into Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market3.6 Mergers & Acquisitions, Expansion Plans4 Covid-19 Implications on Market Size by Type (2015-2026)4.1 Global Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Historic Market Size by Type (2015-2020)4.2 Global Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Forecasted Market Size by Type (2021-2026)5 Covid-19 Implications on Market Size by Application (2015-2026)5.1 Global Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market Size by Application (2015-2020)5.2 Global Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Forecasted Market Size by Application (2021-2026)6 North America6.1 North America Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market Size (2015-2020)6.2 Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Key Players in North America (2019-2020)6.3 North America Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market Size by Type (2015-2020)6.4 North America Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market Size by Application (2015-2020)7 Europe7.1 Europe Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market Size (2015-2020)7.2 Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Key Players in Europe (2019-2020)7.3 Europe Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market Size by Type (2015-2020)7.4 Europe Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market Size by Application (2015-2020)8 China8.1 China Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market Size (2015-2020)8.2 Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Key Players in China (2019-2020)8.3 China Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market Size by Type (2015-2020)8.4 China Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market Size by Application (2015-2020)9 Japan9.1 Japan Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market Size (2015-2020)9.2 Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Key Players in Japan (2019-2020)9.3 Japan Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market Size by Type (2015-2020)9.4 Japan Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market Size by Application (2015-2020)10Key Players Profiles10.1 BioReliance10.1.1 BioReliance Company Details10.1.2 BioReliance Business Overview and Its Total Revenue10.1.3 BioReliance Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Introduction10.1.4 BioReliance Revenue in Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Business (2015-2020))10.1.5 BioReliance Recent Development10.2 Cobra Biologics10.2.1 Cobra Biologics Company Details10.2.2 Cobra Biologics Business Overview and Its Total Revenue10.2.3 Cobra Biologics Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Introduction10.2.4 Cobra Biologics Revenue in Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Business (2015-2020)10.2.5 Cobra Biologics Recent Development10.3 Oxford BioMedica10.3.1 Oxford BioMedica Company Details10.3.2 Oxford BioMedica Business Overview and Its Total Revenue10.3.3 Oxford BioMedica Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Introduction10.3.4 Oxford BioMedica Revenue in Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Business (2015-2020)10.3.5 Oxford BioMedica Recent Development10.4 UniQure10.4.1 UniQure Company Details10.4.2 UniQure Business Overview and Its Total Revenue10.4.3 UniQure Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Introduction10.4.4 UniQure Revenue in Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Business (2015-2020)10.4.5 UniQure Recent Development10.5 FinVector10.5.1 FinVector Company Details10.5.2 FinVector Business Overview and Its Total Revenue10.5.3 FinVector Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Introduction10.5.4 FinVector Revenue in Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Business (2015-2020)10.5.5 FinVector Recent Development10.6 MolMed10.6.1 MolMed Company Details10.6.2 MolMed Business Overview and Its Total Revenue10.6.3 MolMed Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Introduction10.6.4 MolMed Revenue in Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Business (2015-2020)10.6.5 MolMed Recent Development10.7 MassBiologics10.7.1 MassBiologics Company Details10.7.2 MassBiologics Business Overview and Its Total Revenue10.7.3 MassBiologics Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Introduction10.7.4 MassBiologics Revenue in Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Business (2015-2020)10.7.5 MassBiologics Recent Development10.8 Richter-Helm10.8.1 Richter-Helm Company Details10.8.2 Richter-Helm Business Overview and Its Total Revenue10.8.3 Richter-Helm Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Introduction10.8.4 Richter-Helm Revenue in Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Business (2015-2020)10.8.5 Richter-Helm Recent Development10.9 FUJIFILM Diosynth Biotechnologies10.9.1 FUJIFILM Diosynth Biotechnologies Company Details10.9.2 FUJIFILM Diosynth Biotechnologies Business Overview and Its Total Revenue10.9.3 FUJIFILM Diosynth Biotechnologies Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Introduction10.9.4 FUJIFILM Diosynth Biotechnologies Revenue in Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Business (2015-2020)10.9.5 FUJIFILM Diosynth Biotechnologies Recent Development10.10 Lonza10.10.1 Lonza Company Details10.10.2 Lonza Business Overview and Its Total Revenue10.10.3 Lonza Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Introduction10.10.4 Lonza Revenue in Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Business (2015-2020)10.10.5 Lonza Recent Development10.11 Aldevron10.11.1 Aldevron Company Details10.11.2 Aldevron Business Overview and Its Total Revenue10.11.3 Aldevron Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Introduction10.11.4 Aldevron Revenue in Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Business (2015-2020)10.11.5 Aldevron Recent Development10.12 Eurogentec10.12.1 Eurogentec Company Details10.12.2 Eurogentec Business Overview and Its Total Revenue10.12.3 Eurogentec Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Introduction10.12.4 Eurogentec Revenue in Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Business (2015-2020)10.12.5 Eurogentec Recent Development10.13 Cell and Gene Therapy Catapult10.13.1 Cell and Gene Therapy Catapult Company Details10.13.2 Cell and Gene Therapy Catapult Business Overview and Its Total Revenue10.13.3 Cell and Gene Therapy Catapult Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Introduction10.13.4 Cell and Gene Therapy Catapult Revenue in Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Business (2015-2020)10.13.5 Cell and Gene Therapy Catapult Recent Development10.14 Biovian10.14.1 Biovian Company Details10.14.2 Biovian Business Overview and Its Total Revenue10.14.3 Biovian Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Introduction10.14.4 Biovian Revenue in Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Business (2015-2020)10.14.5 Biovian Recent Development10.15 Brammer Bio10.15.1 Brammer Bio Company Details10.15.2 Brammer Bio Business Overview and Its Total Revenue10.15.3 Brammer Bio Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Introduction10.15.4 Brammer Bio Revenue in Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Business (2015-2020)10.15.5 Brammer Bio Recent Development10.16 VGXI10.16.1 VGXI Company Details10.16.2 VGXI Business Overview and Its Total Revenue10.16.3 VGXI Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Introduction10.16.4 VGXI Revenue in Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Business (2015-2020)10.16.5 VGXI Recent Development10.17 PlasmidFactory10.17.1 PlasmidFactory Company Details10.17.2 PlasmidFactory Business Overview and Its Total Revenue10.17.3 PlasmidFactory Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Introduction10.17.4 PlasmidFactory Revenue in Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Business (2015-2020)10.17.5 PlasmidFactory Recent Development10.18 bluebird bio10.18.1 bluebird bio Company Details10.18.2 bluebird bio Business Overview and Its Total Revenue10.18.3 bluebird bio Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Introduction10.18.4 bluebird bio Revenue in Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Business (2015-2020)10.18.5 bluebird bio Recent Development10.19 Novasep10.19.1 Novasep Company Details10.19.2 Novasep Business Overview and Its Total Revenue10.19.3 Novasep Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Introduction10.19.4 Novasep Revenue in Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Business (2015-2020)10.19.5 Novasep Recent Development10.20 Spark Therapeutics10.20.1 Spark Therapeutics Company Details10.20.2 Spark Therapeutics Business Overview and Its Total Revenue10.20.3 Spark Therapeutics Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Introduction10.20.4 Spark Therapeutics Revenue in Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Business (2015-2020)10.20.5 Spark Therapeutics Recent Development10.21 Vigene Biosciences10.21.1 Vigene Biosciences Company Details10.21.2 Vigene Biosciences Business Overview and Its Total Revenue10.21.3 Vigene Biosciences Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Introduction10.21.4 Vigene Biosciences Revenue in Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Business (2015-2020)10.21.5 Vigene Biosciences Recent Development11Analysts Viewpoints/Conclusions12Appendix12.1 Research Methodology12.1.1 Methodology/Research Approach12.1.2 Data Source12.2 Disclaimer12.3 Author Details

About Us:

QYResearch always pursuits high product quality with the belief that quality is the soul of business. Through years of effort and supports from huge number of customer supports, QYResearch consulting group has accumulated creative design methods on many high-quality markets investigation and research team with rich experience. Today, QYResearch has become the brand of quality assurance in consulting industry.

More here:
Viral Vectors, Non-Viral Vectors and Gene Therapy Manufacturing Market 2020: Global Size, Supply-Demand, Product Type and End User Analysis To...

Recommendation and review posted by Bethany Smith

NOVATO Apr 30, 2020 (Thomson StreetEvents) -- Edited Transcript of Biomarin Pharmaceutical Inc earnings conference call or presentation Wednesday, April 29, 2020 at 8:15:00pm GMT

* Brian R. Mueller

BioMarin Pharmaceutical Inc. - Senior VP of Finance, Acting CFO & CAO

* Henry J. Fuchs

BioMarin Pharmaceutical Inc. - President of Worldwide Research & Development

BioMarin Pharmaceutical Inc. - Chairman & CEO

BioMarin Pharmaceutical Inc. - Executive VP & Chief Commercial Officer

* Robert A. Baffi

BioMarin Pharmaceutical Inc. - President of Global Manufacturing & Technical Operations

BioMarin Pharmaceutical Inc. - VP of IR

Evercore ISI Institutional Equities, Research Division - Senior MD & Equity Analyst

* Kennen B. MacKay

RBC Capital Markets, Research Division - MD & Co-Head of US Biotechnology Research

* Peter B. Kim

* Philip M. Nadeau

William Blair & Company L.L.C., Research Division - Co-Group Head of Biopharma Equity Research

Sanford C. Bernstein & Co., LLC., Research Division - VP

Welcome to the BioMarin First Quarter 2020 Financial Results Conference Call. Hosting the conference call today from BioMarin is Traci McCarty, Vice President of Investor Relations. Please go ahead, Traci.

Traci McCarty, BioMarin Pharmaceutical Inc. - VP of IR [2]

Thank you, May, and thank you, everyone, for joining us today. To remind you, this nonconfidential presentation contains forward-looking statements about the business prospects of BioMarin, including expectations regarding BioMarin's financial performance, commercial products and potential future products in different areas of therapeutic research and development.

Results may differ materially depending on the progress of BioMarin's product programs, actions of regulatory authorities, availability of capital, future actions in the pharmaceutical market and developments by competitors, and those factors detailed in BioMarin's filings with the Securities and Exchange Commission, such as 10-Q, 10-K and 8-K reports.

On the call remotely from BioMarin management today are J.J. Bienaim, Chairman and Chief Executive Officer; Jeff Ajer, Executive Vice President, Chief Commercial Officer; Robert Baffi, President, Global Manufacturing and Technical Operations; Hank Fuchs, President, Worldwide Research and Development; and Brian Mueller, acting Chief Financial Officer. We hope to keep this call to 1 hour and also give everyone the opportunity to ask a question today, so we request that you limit yourself to one during the Q&A portion of the call. Thank you for your understanding. I will now turn the call over to our Chairman and CEO, J.J. Bienaim.

--------------------------------------------------------------------------------

Jean-Jacques Bienaim, BioMarin Pharmaceutical Inc. - Chairman & CEO [3]

--------------------------------------------------------------------------------

Thank you, Traci. Good afternoon, and thank you for joining us on today's call. We hope you and your families are healthy and managing through these unusual circumstances brought about by the COVID-19 virus. So these are unprecedented times, but the essential nature of our medicines to the patients who need them has enabled BioMarin to weather the challenge of COVID-19 quite well. Equally as important, I want to underscore the extraordinary dedication of our employees who have kept operations running smoothly in order to maintain access to our therapies around the world.

Our first quarter record results of $502 million of total revenues or 25% growth over last year, the testament to the importance of our therapies and our diversified product base and commercial footprint. Due in part to the sale of Firdapse, GAAP net income in the first quarter was $81.4 million, exceeding our current full year guidance range of $20 million to $80 million.

In the first quarter, we experienced minimal interruptions due to COVID-19, but we do anticipate the potential for more meaningful business disruptions for the remainder of 2020 due to the pandemic. As a result, we have chosen to reduce our full year total revenue guidance by around 5% or a total of $100 million, while maintaining both GAAP and non-GAAP income fully estimated provided earlier this year. Despite potential near-term impacts to our commercial business on COVID-19, our next blockbusters, BMN 270, valoctocogene roxaparvovec, (inaudible) valrox for hemophilia A and vosoritide for achondroplasia continuing to advance, and Jeff will reveal our recently approved brand name for BMN 270 in a moment.

Briefly on vosoritide for achondroplasia. In the quarter, we announced that based on recent meetings, a successful meeting with health authorities in the U.S. and Europe, we plan to submit marketing applications to the FDA and EMA in the third quarter of this year. If approved, vosoritide will be the first medicine for the treatment of achondroplasia in the U.S. and Europe. So we are delighted that this potential therapy proceeds a step closer to regulatory.

In conclusion, BioMarin employees have risen to the evolving challenges of the COVID-19 pandemic, demonstrating a high level of commitment and dedication to the patients we serve. The underlying fundamentals of our business remains strong and our manufacturing and supply chain resilience. We have built a durable base business with essential medicines transition the pipeline to address larger rare indications, diversified risk and positions ourselves for substantial success in both the near term and the long term. We are confident in our ability to manage through this ongoing global health crisis, while staying grounded in our long-term strategy for success.

I'd like to say a few words about Robert Baffi, who has made tremendous contributions to the organization over the last 20 years. During this time at BioMarin, he has manufactured the most complex biological products in the world and visits the most advanced commercial scale gene therapy manufacturing capability. His leadership, technical expertise, foresight and dedication has played a key role in where we stand today, and we want to acknowledge his many contributions. Thank you, Robert. And we are pleased that he will remain with BioMarin through the review of BMN 270 valrox and the vosoritide marketing applications to ensure manufacturing continuity as the successor, Greg Guyer, begins his journey with us in May, coming from Bristol-Myers Squibb.

Thank you all for your continued support. And now I would like to turn the call over to Robert to say a few words. Robert?

--------------------------------------------------------------------------------

Robert A. Baffi, BioMarin Pharmaceutical Inc. - President of Global Manufacturing & Technical Operations [4]

--------------------------------------------------------------------------------

Thank you, J.J. Innovation has always been at the core of BioMarin's success. During my 20 years, as the Head of Technical Operations, and has instill in the company a few guiding principles to foster a culture of innovation: first, let science inform and lead decision-making; second, let compliance focus our efforts on patient safety and clinical outcomes; and third, let ingenuity create adaptivity and resiliency in our approach to drug development. These 3 tenants, infused with the talents of the most dedicated people I've ever worked with, have consistently enabled us to take research ideas rapidly through development, navigating the complexity of the regulatory approval process in a highly effective and differentiated manner to meet the needs of patients.

BioMarin's leadership team has shared and supported the vision for creating a fully integrated company with technical operations, powers clinical studies and commercial demand, and is an integral component of strategic technology development paradigms for assuring the timely delivery of an uninterrupted supply of product.

Furthermore, innovative and appropriately implemented CMC strategies linked to a faster clinical design allows for rapid development and high success rates that benefit both patients and shareholders alike. As a company, we are going through multiple transitions simultaneously, challenging in some ways, invigorating in others. Our transition to profitability this year provides the resources to develop more innovative therapies. Our transition to gene therapy product leverages our clinical manufacturing and commercial capabilities and place us squarely at the forefront of the emerging technological advancement in precision medicine. Our transition and technical operation leadership provides the opportunity to build an innovative approach to drug development to fuel our growth.

When I first saw that to Dr. Greg Guyer's CV, I could not help but be impressed with the scope of his responsibility and the experiential variety and diversity of his career. In many ways, while a different journey, it shared a lot of commonality with my own and that is not to let us vote to BioMarin. I am confident and committed that the transition in technical operations at BioMarin from me to Greg will build on the legacy of science, compliance and ingenuity, for our patients that will benefit from the products that will emerge from our efforts, for our employees and their careers, and for our shareholders as we become profitable.

In terms of licensure of our gene therapy manufacturing facility in support of BMN 270 approval, I'm pleased to share that the Health Products Regulatory Authority of Ireland conducted, on behalf of the European Medicines Agency, a pre-approval inspection in Q1. This inspection involves a detailed review of the facility, equipment, process, and analytical studies and relevant documentations generated in support of validation, production and testing. Following this inspection, a CGMP certification was granted, allowing for commercial production and distribution of BMN 270 in the EU when the product is approved.

At present, the inspection of the facility by FDA is expected to be completed during Q2, allowing full licensure in the U.S. of the facility consistent with the August 21 PDUFA action date. We have more than 400 doses of commercial BMN 270 ready for potential launch later this year, and remain very enthusiastic about the prospects for introducing the first gene therapy product for a bleeding disorder to the hemophilia community as soon as possible.

I thank you for your support throughout my time at BioMarin. And now I'd like to turn the call over to Jeff to discuss the commercial business update. Jeff?

--------------------------------------------------------------------------------

Jeffrey Robert Ajer, BioMarin Pharmaceutical Inc. - Executive VP & Chief Commercial Officer [5]

--------------------------------------------------------------------------------

Thank you, Robert. As we begin 2020, I'm very pleased with the team's performance across all brands and all regions during the quarter. As J.J. mentioned, we achieved our highest quarterly revenue on record, with total revenues of $502 million in the first quarter with net product revenues marketed by BioMarin, up 24% to $433 million. This achievement reflects the fundamental strength and growth of our business despite near-term challenges related to COVID-19, which I will address in a moment.

On to results in the quarter and starting with Palynziq. In the U.S., the trend of increasing revenue based on a steadily growing base of patients on commercial therapy, including progression from induction and titration to daily maintenance dosing, continued in Q1. In the early part of the quarter, we did experience a seasonal slowing of new patient enrollments and patient starts, somewhat mirroring our historical experience with Kuvan in the United States. We are reporting $35 million in Palynziq revenue for the first quarter, with the majority of that revenue coming from the U.S.

In Europe, in the first quarter, multiple clinics across Germany continued to actively treat patients with Palynziq and early uptake signals are encouraging. During the quarter, we made significant progress in Germany, adding clinics that now have some experience prescribing Palynziq and managing patients through the induction and titration phase to daily maintenance dosing. As the number of commercial patients in Germany steadily grows, we anticipate meaningful revenue contribution from the EU starting this year. We anticipate finalizing price and reimbursement negotiations in Germany by mid this year, an important step toward getting price and reimbursement approvals in other high priority European markets.

Kuvan contributed $122 million in revenues in the quarter or 14% growth year-over-year, with most of that growth coming from the United States. Vimizim revenues grew 9% year-over-year, contributing $137 million in the first quarter, driven by an 11% increase in patients year-over-year. This is reflective of the continued anticipated growth potential we expect for Vimizim.

Turning to Naglazyme. Revenues totaled $114 million, a 32% year-over-year growth for the well-established brand. As with Vimizim, the impact from uneven large order patterns makes the quarterly comparison difficult. The number of commercial patients on Naglazyme grew by 6% in the past year, and is indicative of the ongoing growth potential for this brand, nearly 15 years since being approved.

And finally, Brineura contributed $24 million in net product revenues, which represented 97% year-over-year growth. These revenues were essentially flat over Q4, and that was driven by a modest year-end inventory build in the EMEA region in Q4. Importantly, the growth in Brineura revenues compared to prior year reflects an underlying growth of 86% in commercial patients. We are seeing a net increase in patients benefiting from Brineura treatment due to the success of our disease awareness and patient identification programs.

Taken together, we are pleased with first quarter results and demand for our products. And while we experienced minimal financial impact in the first quarter due to COVID-19, we anticipate the potential for a higher degree of impact during the remainder of 2020 as disruptions of day-to-day operations of clinics and hospitals flow through our business.

Our global commercial teams will continue to adjust to implement innovative approaches to engage with clinics and patients to ensure continuity of access to our medicines. Where possible, we are supporting home infusion efforts to help mitigate impact. However, some COVID-19 disruption, the new patient starts as well as to ongoing infusion center visits from existing patients are expected to continue. As a result, we are reducing total revenue guidance by 5% at the midpoint to between $1,850 million to $1,950 million for the full year 2020. The vast majority of today's updated total revenue guidance reflects adjustments to in line brands, including Vimizim, Naglazyme and Palynziq. And assumes our business will return to normalized demand patterns in the second half of 2020. Although we did not give BMN 270 2020 revenue guidance in February, our 2020 total revenue guidance did assume some contribution from BMN 270 in Europe.

And now I'd like to end my remarks with an update on our hemophilia gene therapy program and introduce you to the intended brand name, ROCTAVIAN. In previous calls, you've heard references to valrox, which was an abbreviated form of our INN or international nonproprietary name, valoctocogene roxaparvovec or alternatively, our program identifier, BMN 270. Both the FDA and the EMA have accepted ROCTAVIAN as our brand name, and we look forward to adopting ROCTAVIAN as we get closer to launch. In the meantime, we will cease to use valrox, so as to not confuse it with our intended brand name.

Other key launch readiness activities have continued to progress. We have essentially built out the commercial team in the United States, and have added key individuals to support priority in markets in the EU. The majority of these new employees have substantial and diverse experience in hemophilia. Our brand campaigns also continue to develop as anticipated and teams have pivoted to virtual and digital platforms, allowing for ongoing engagement with the marketplace in lieu of face-to-face interactions. Obviously, certain activities are more amenable to virtual engagements than others, and where COVID-19 is challenging us most in the short-term is with gene therapy educational programs and site readiness.

Fortunately, with the team already on board, we anticipate being well prepared to launch if we receive regulatory approvals. In the meantime, we have recently finished some very positive pricing research, which validated payer willingness to embrace ROCTAVIAN with the current data set, and we'll look forward to providing you with updates on our pricing at launch.

Thank you for your attention, and I will now turn the call over to Hank to provide an R&D update. Hank?

--------------------------------------------------------------------------------

Henry J. Fuchs, BioMarin Pharmaceutical Inc. - President of Worldwide Research & Development [6]

--------------------------------------------------------------------------------

Thanks, Jeff. I'd also like to echo J.J.'s expression of deep and heartfelt appreciation for the time Robert has spent with us. And also to welcome Greg Guyer, to the organization where the secret sauce is bottled.

The R&D organization is delighted that our next significant product opportunities continue to progress, particularly under the circumstances brought about by COVID-19. The ability to come to work mostly virtually and focus on the advancement of our innovative products to date, ROCTAVIAN and vosoritide has been especially gratifying and a welcome distraction from the ongoing pandemic. I want to acknowledge and thank our teams for their commitment and contributions during these challenging times. I have been impressed by your flexibility and your ability to keep the story going while we are dealing with the pandemic.

Starting with ROCTAVIAN, and with a strong and memorable brand name, congratulations, Jeff, the FDA is committed to meet the August 21 PDUFA action date. In Europe, our marketing authorization application filing remains on accelerated assessment at this time. However, the review procedure is to be extended by at least 3 months due to COVID-19 delays. Further, as is the case with most filings that initially receive accelerated assessment, we believe there is a high possibility that our M&A will revert to a standard review procedure from accelerated assessment. Based on these assumptions, we expect the CHMP opinion by late '20 or early '21.

We continue to plan to share our 3 -- our 4-year update of the 16, 13 vector genome per kilo dose as well as the 3-year update on the 40, 13 vector genome per kilo dose in the middle of the year, but the form is as yet to be defined given the changing environment for medical meetings. We have a data analysis plan in place. We'll move forward with business as usual, but the venue and method for providing the update is still fluid at this point. So thanks for bearing with us.

Importantly, we do not expect COVID-19 to impact the time lines for completion of the ROCTAVIAN Phase III trial. Enrollment was completed in November of last year, and one of the benefits of being a onetime treatment is that patients do not need to receive therapy on a chronic basis. We're also confident that the integrity of the ongoing data collection for the study -- for this pivotal study is being sufficiently maintained as home health care solutions align nicely with the collection of the primary endpoint annualized bleed rate data.

Turning now to vosoritide for the treatment of achondroplasia. As J.J. mentioned, we plan to submit a global marketing applications in the third quarter of this year. Our multipronged development program, including a long-term Phase II clinical results in 5 to 18-year-old children, comprehensive natural history data, the ongoing study of newborns through 5 years and the highly statistically significant placebo-controlled Phase III trial makes for a very comprehensive data package spanning more than 5 years of treatment with children with achondroplasia. Again, we're the beneficiary of fortunate timing and that our pivotal submission data read out prior to the pandemic, and now much of the work can be concluded remotely. If approved, vosoritide would be the first and only medicine designated for the treatment of achondroplasia in the U.S. and in European Union.

We continue to look forward to publishing the full data from the Phase III study later this year, and we're pleased to let you know that our late-breaker has been accepted in an upcoming medical Congress. The presentation will include 1 year growth velocity, height Z scores, body proportionality, safety and subgroup analyses. So stay tuned for more specifics as to when and where those data will appear.

The Phase II study of vosoritide in 0 to 5 year olds, referred to as study 206, is proceeding well, and we are very pleased that safety data from children ages 6 months to 5 years participating in that study will be available as part of our registration package. We're grateful that the timing of key studies has aligned well with our pre-COVID-19 plans.

Moving to BMN 307, our investigational gene therapy for phenylketonuria. We're continuing to prepare new sites to open in order to enroll patients when it is safely do so given the COVID-19 circumstances. We're excited about the prospect of BMN 307 as it represents a third treatment for phenylketonuria in our PKU franchise and a second gene therapy development program, leveraging our learnings and capabilities from ROCTAVIAN. Currently, we expect the study to start later -- we expect to start the study later in 2020.

The R&D organization is energized by the opportunities before us in 2020, with both ROCTAVIAN for severe hemophilia A and vosoritide for children with achondroplasia advancing towards potential approvals. We are hopeful that these innovative treatments will be available in the very near future. We look forward to updating you on our progress over the coming quarters, and thank you for your continued support.

And I'll now turn the call over to Brian to review the financials.

--------------------------------------------------------------------------------

Brian R. Mueller, BioMarin Pharmaceutical Inc. - Senior VP of Finance, Acting CFO & CAO [7]

--------------------------------------------------------------------------------

Thank you, Hank. Please refer to today's press release summarizing our financial results for full details on the first quarter of 2020, and as usual, our comprehensive report on the quarter will be available in our upcoming Form 10-Q, which we are on track to file over the next couple of days.

As Jeff mentioned, we are experiencing some modest impacts from the COVID-19 pandemic and as a result, we have updated full year total revenue guidance to between $1.85 billion to $1.95 billion. As Jeff noted,our updated revenue guidance is based on the assumption that our business will return to normalized demand patterns in the second half of the year.

Importantly, while we lowered our revenue guidance due to the impact of COVID-19 on our commercial business, we were able to analyze our 2020 spending projections and make adjustment that allowed us to maintain our prior GAAP and non-GAAP income guidance despite the lower revenue.

Moving to operating expenses. R&D expense for the first quarter of 2020 was $142 million and lower compared to R&D expense for the first quarter of 2019 of $184 million, mostly due to less R&D activity for ROCTAVIAN, given its late stage of development as well as Palynziq following its approvals in the U.S. and Europe.

SG&A expense for the first quarter of '20 was $187 million, which was higher than SG&A expense for the first quarter of 2019 of $162 million. The year-over-year increase was expected with the single largest driver, being the commercial preparation for the launch of ROCTAVIAN and the continued global launch of Palynziq. We also incurred some unpredicted foreign currency exchange losses during the month of March as the COVID pandemic negatively affected some of our assets denominated and some of the more volatile global currencies.

During the bottom line results, we reported GAAP net income of $81 million in the first quarter of 2020, compared to a GAAP net loss of $56.5 million in the first quarter of 2019. The improvement in GAAP income was primarily due to higher revenue, lower R&D expenses and the gain on the sale of the deferred tax assets. With higher revenues and lower R&D expenses, non-GAAP income of $117 million in the first quarter of 2020 grew substantially as compared to Q1 2019 non-GAAP income of $25 million. Both of these first quarter 2020 bottom line results gives us a great start towards achieving our 2020 goals of GAAP net income on an annual basis for the first time in the company's history, a considerable growth in non-GAAP income.

I'd also like to touch on the potential tax benefit that we mentioned last quarter that may be recognized in the second half of this year. Our current 2020 GAAP net income guidance of between $20 million to $80 million, excludes the potential impact of intra-entity intangible asset transfers between BioMarin entities. If these intangible asset transfers occur, we estimate that the tax effect could result in a onetime noncash income tax benefit of greater than $500 million. As I mentioned previously, you may have seen similar transactions completed by some of our larger peers in recent quarters.

Speaking to total cash and investments, we ended the first quarter of 2020 with $1.15 billion compared to $1.17 billion at the end of December 2019. The modest decrease in total cash and investments during Q1 2020 was largely due to some timing of operating cash flows. However, the significant improvement over the first quarter of 2019 where total cash and investments decreased by $105 million. This valid cash position, coupled with vibrant business fundamentals, put us in good standing to manage through the continued uncertainty related to COVID-19.

In closing, the stronger performance of the business during the first quarter of 2020, plus our positive financial outlook for the rest of the year, indicate that 2020 should be a transformational year for the company. And the prospects of value to come from ROCTAVIAN and vosoritide, if they are approved commercially, give us an enthusiasm about our future.

Thank you for your support, and we will now open the call to your questions. Operator?

================================================================================

Questions and Answers

--------------------------------------------------------------------------------

Operator [1]

--------------------------------------------------------------------------------

(Operator Instructions) Our first question is from the line of Robyn Karnauskas from Suntrust.

--------------------------------------------------------------------------------

Robyn Kay Shelton Karnauskas, SunTrust Robinson Humphrey, Inc., Research Division - Research Analyst [2]

--------------------------------------------------------------------------------

And just first off, congratulations to Greg. But to Rob, it was lovely working with you. I think you brought a breath of fresh air to working with management teams in all of my buyers (inaudible). So thank you so much. I learned a lot. I guess I'm going to start-up with some questions on ROCTAVIAN, and I hope I get that correctly. So first of all, what gives you confidence that in the United States, that there won't be any more delays? People ask me this nonstop. And then when you talk about assuming normal operations go -- resume in the second half, is that in the beginning of the second half? Do you have a time line for that? If it goes into fourth quarter, could we see further delays?

And the third question is, what are you hearing as far as like people willing to have gene therapy procedures done in the COVID environment as early as fourth quarter? Are people open to it? Is it separate from the hospitals? Or what are you hearing from the ground?

--------------------------------------------------------------------------------

Jean-Jacques Bienaim, BioMarin Pharmaceutical Inc. - Chairman & CEO [3]

--------------------------------------------------------------------------------

Okay. Hi. (inaudible) do you want to answer the question on the no delays with the FDA? Hank?

--------------------------------------------------------------------------------

More:
Edited Transcript of BMRN earnings conference call or presentation 29-Apr-20 8:15pm GMT - Yahoo Finance

Recommendation and review posted by Bethany Smith

Gene Therapy Market report covers the present and past market scenarios, market development patterns, and is likely to proceed with a continuing development over the forecast period. The research report on Market provides comprehensive analysis on market status and development trend, including types, applications, rising technology and region. A number of analysis tools such as SWOT analysis and Porters five forces analysis have been employed to provide an accurate understanding of this market.

Some of the key players of Market:Adaptimmune Therapeutics Plc., Anchiano Therapeutics Ltd., Achieve Life Sciences, Inc., Adverum Biotechnologies, Inc., Abeona Therapeutics Inc., Applied Genetic Technologies Corporation, Arbutus Biopharma Corporation,, Audentes Therapeutics, Inc., AveXis, Inc., Bluebird Bio, Inc., Celgene Corporation and more

Get Sample Copy of this Report @ https://www.reportsweb.com/inquiry&RW00013228326/sample

The Global Gene Therapy Market research report offers an in-depth analysis of the global market, providing relevant information for the new market entrants or well-established players. Some of the key strategies employed by leading key players operating in the market and their impact analysis have been included in this research report.

Segmentation by product type:Antigen, Cytokine, Tumor Suppressor, Suicide, Deficiency, Growth Factors, Receptors, and Others

Segmentation by application:Oncological Disorders, Rare Diseases, Cardiovascular Diseases, Neurological Disorders, Infectious Disease, and Other Diseases

Get Discount for This Report @ https://www.reportsweb.com/inquiry&RW00013228326/discount

The report provides a detailed overview of the industry including both qualitative and quantitative information. It provides overview and forecast of the global Gene Therapy market based on product and application. It also provides market size and forecast till 2023 for overall Gene Therapy market with respect to five major regions, namely; North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA) and South America (SAM), which is later sub-segmented by respective countries and segments.

Table of content

Purchase This Report @ https://www.reportsweb.com/buy&RW00013228326/buy/5370

About ReportsWeb:ReportsWeb.com is a one stop shop of market research reports and solutions to various companies across the globe. We help our clients in their decision support system by helping them choose most relevant and cost effective research reports and solutions from various publishers. We provide best in class customer service and our customer support team is always available to help you on your research queries.

Contact Us:Call: +1-646-491-9876Email: [emailprotected]

Read more:
Gene Therapy Market: how to drive decisions and growth in a business by top key players like Audentes Therapeutics, Inc., AveXis, Inc., Bluebird...

Recommendation and review posted by Bethany Smith

Scientists from the University of Sheffield have produced the first high-resolution images of the structure of the cell wall of bacteria, in a study that could further understanding of antimicrobial resistance.The research, published in Nature, revealed a new and unexpected structure of the outer bacterial layers of the bacterium Staphylococcus aureus.

The findings set a new framework for understanding how bacteria grow and how antibiotics work, overturning previous theories about the structure of the outer bacterial layers.

The images give unprecedented insight into the composition of the bacterial cell wall and will inform new approaches to developing antibiotics in order to combat antibiotic resistance. There are no other examples of studies of the cell wall in any organism at comparable resolution, down to the molecular scale.

Laia Pasquina Lemonche, a PhD Researcher from the University of Sheffields Department of Physics and Astronomy, said: Many antibiotics work by inhibiting the bacterias production of a cell wall, a strong but permeable skin around the bacteria which is critical for its survival.

We still dont understand how antibiotics like penicillin kill bacteria, but this isnt surprising because until now we had remarkably little information about the actual organisation of the bacterial cell wall. This study provides that essential stepping stone which we hope will lead to both a better understanding of how antibiotics work and to the future development of new approaches to combat antimicrobial resistance.

The team used an advanced microscopy technique called Atomic Force Microscopy (AFM), which works by using a sharp needle to feel the shape of a surface and build an image similar to a contour map, but at the scale of individual molecules.

Professor Jamie Hobbs, Professor of Physics at the University of Sheffield, said: It is by physicists and biologists working together that we've been able to make these breakthroughs in our understanding of the bacterial cell wall.

The researchers are now using the same techniques to understand how antibiotics change the architecture of the cell wall and also how changes in the cell wall are important in antimicrobial resistance.ReferencePasquina-Lemonche et al. (2020). The architecture of the Gram-positive bacterial cell wall. Nature. DOI: https://doi.org/10.1038/s41586-020-2236-6

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

Original post:
First High-resolution Images of Bacterial Cell Wall - Technology Networks

Recommendation and review posted by Bethany Smith

Complete study of the global Gene Therapies for Cancer Treatment market is carried out by the analysts in this report, taking into consideration key factors like drivers, challenges, recent trends, opportunities, advancements, and competitive landscape. This report offers a clear understanding of the present as well as future scenario of the global Gene Therapies for Cancer Treatment industry. Research techniques like PESTLE and Porters Five Forces analysis have been deployed by the researchers. They have also provided accurate data on Gene Therapies for Cancer Treatment production, capacity, price, cost, margin, and revenue to help the players gain a clear understanding into the overall existing and future market situation.

Key companies operating in the global Gene Therapies for Cancer Treatment market include , Takara Bio, Tocagen, VBL Therapeutics, Cold Genesys, Genprex, Momotaro-Gene, MultiVir, SynerGene Therapeutics, Ziopharm Oncology, Anchiano Therapeutics, Celgene, Celsion, Bluebird Bio Gene Therapies for Cancer Treatment

Get PDF Sample Copy of the Report to understand the structure of the complete report: (Including Full TOC, List of Tables & Figures, Chart) :

https://www.qyresearch.com/sample-form/form/1685717/covid-19-impact-on-global-gene-therapies-for-cancer-treatment-market

Segmental Analysis

The report has classified the global Gene Therapies for Cancer Treatment industry into segments including product type and application. Every segment is evaluated based on growth rate and share. Besides, the analysts have studied the potential regions that may prove rewarding for the Gene Therapies for Cancer Treatment manufcaturers in the coming years. The regional analysis includes reliable predictions on value and volume, thereby helping market players to gain deep insights into the overall Gene Therapies for Cancer Treatment industry.

Global Gene Therapies for Cancer Treatment Market Segment By Type:

, Somatic Cell Gene Therapy (SCGT), Germline Gene Therapy (GGT) Gene Therapies for Cancer Treatment

Global Gene Therapies for Cancer Treatment Market Segment By Application:

, Cancer Research Centers, Diagnostic Laboratories, Cancer Hospitals, Others

Competitive Landscape

It is important for every market participant to be familiar with the competitive scenario in the global Gene Therapies for Cancer Treatment industry. In order to fulfil the requirements, the industry analysts have evaluated the strategic activities of the competitors to help the key players strengthen their foothold in the market and increase their competitiveness.

Key companies operating in the global Gene Therapies for Cancer Treatment market include , Takara Bio, Tocagen, VBL Therapeutics, Cold Genesys, Genprex, Momotaro-Gene, MultiVir, SynerGene Therapeutics, Ziopharm Oncology, Anchiano Therapeutics, Celgene, Celsion, Bluebird Bio Gene Therapies for Cancer Treatment

Key questions answered in the report:

Get Full Report in your inbox within 24 hours at USD(3900)

https://www.qyresearch.com/settlement/pre/2b635ea3aa0ae60f9ed63d481d8cfa13,0,1,covid-19-impact-on-global-gene-therapies-for-cancer-treatment-market

TOC

1 Report Overview1.1 Study Scope1.2 Key Market Segments1.3 Players Covered: Ranking by Gene Therapies for Cancer Treatment Revenue1.4 Market Analysis by Type1.4.1 Global Gene Therapies for Cancer Treatment Market Size Growth Rate by Type: 2020 VS 20261.4.2 Somatic Cell Gene Therapy (SCGT)1.4.3 Germline Gene Therapy (GGT)1.5 Market by Application1.5.1 Global Gene Therapies for Cancer Treatment Market Share by Application: 2020 VS 20261.5.2 Cancer Research Centers1.5.3 Diagnostic Laboratories1.5.4 Cancer Hospitals1.5.5 Others1.6 Coronavirus Disease 2019 (Covid-19): Gene Therapies for Cancer Treatment Industry Impact1.6.1 How the Covid-19 is Affecting the Gene Therapies for Cancer Treatment Industry1.6.1.1 Gene Therapies for Cancer Treatment Business Impact Assessment Covid-191.6.1.2 Supply Chain Challenges1.6.1.3 COVID-19s Impact On Crude Oil and Refined Products1.6.2 Market Trends and Gene Therapies for Cancer Treatment Potential Opportunities in the COVID-19 Landscape1.6.3 Measures / Proposal against Covid-191.6.3.1 Government Measures to Combat Covid-19 Impact1.6.3.2 Proposal for Gene Therapies for Cancer Treatment Players to Combat Covid-19 Impact1.7 Study Objectives1.8 Years Considered2 Global Growth Trends by Regions2.1 Gene Therapies for Cancer Treatment Market Perspective (2015-2026)2.2 Gene Therapies for Cancer Treatment Growth Trends by Regions2.2.1 Gene Therapies for Cancer Treatment Market Size by Regions: 2015 VS 2020 VS 20262.2.2 Gene Therapies for Cancer Treatment Historic Market Share by Regions (2015-2020)2.2.3 Gene Therapies for Cancer Treatment Forecasted Market Size by Regions (2021-2026)2.3 Industry Trends and Growth Strategy2.3.1 Market Top Trends2.3.2 Market Drivers2.3.3 Market Challenges2.3.4 Porters Five Forces Analysis2.3.5 Gene Therapies for Cancer Treatment Market Growth Strategy2.3.6 Primary Interviews with Key Gene Therapies for Cancer Treatment Players (Opinion Leaders)3 Competition Landscape by Key Players3.1 Global Top Gene Therapies for Cancer Treatment Players by Market Size3.1.1 Global Top Gene Therapies for Cancer Treatment Players by Revenue (2015-2020)3.1.2 Global Gene Therapies for Cancer Treatment Revenue Market Share by Players (2015-2020)3.1.3 Global Gene Therapies for Cancer Treatment Market Share by Company Type (Tier 1, Tier 2 and Tier 3)3.2 Global Gene Therapies for Cancer Treatment Market Concentration Ratio3.2.1 Global Gene Therapies for Cancer Treatment Market Concentration Ratio (CR5 and HHI)3.2.2 Global Top 10 and Top 5 Companies by Gene Therapies for Cancer Treatment Revenue in 20193.3 Gene Therapies for Cancer Treatment Key Players Head office and Area Served3.4 Key Players Gene Therapies for Cancer Treatment Product Solution and Service3.5 Date of Enter into Gene Therapies for Cancer Treatment Market3.6 Mergers & Acquisitions, Expansion Plans4 Breakdown Data by Type (2015-2026)4.1 Global Gene Therapies for Cancer Treatment Historic Market Size by Type (2015-2020)4.2 Global Gene Therapies for Cancer Treatment Forecasted Market Size by Type (2021-2026)5 Gene Therapies for Cancer Treatment Breakdown Data by Application (2015-2026)5.1 Global Gene Therapies for Cancer Treatment Market Size by Application (2015-2020)5.2 Global Gene Therapies for Cancer Treatment Forecasted Market Size by Application (2021-2026)6 North America6.1 North America Gene Therapies for Cancer Treatment Market Size (2015-2020)6.2 Gene Therapies for Cancer Treatment Key Players in North America (2019-2020)6.3 North America Gene Therapies for Cancer Treatment Market Size by Type (2015-2020)6.4 North America Gene Therapies for Cancer Treatment Market Size by Application (2015-2020)7 Europe7.1 Europe Gene Therapies for Cancer Treatment Market Size (2015-2020)7.2 Gene Therapies for Cancer Treatment Key Players in Europe (2019-2020)7.3 Europe Gene Therapies for Cancer Treatment Market Size by Type (2015-2020)7.4 Europe Gene Therapies for Cancer Treatment Market Size by Application (2015-2020)8 China8.1 China Gene Therapies for Cancer Treatment Market Size (2015-2020)8.2 Gene Therapies for Cancer Treatment Key Players in China (2019-2020)8.3 China Gene Therapies for Cancer Treatment Market Size by Type (2015-2020)8.4 China Gene Therapies for Cancer Treatment Market Size by Application (2015-2020)9 Japan9.1 Japan Gene Therapies for Cancer Treatment Market Size (2015-2020)9.2 Gene Therapies for Cancer Treatment Key Players in Japan (2019-2020)9.3 Japan Gene Therapies for Cancer Treatment Market Size by Type (2015-2020)9.4 Japan Gene Therapies for Cancer Treatment Market Size by Application (2015-2020)10 Southeast Asia10.1 Southeast Asia Gene Therapies for Cancer Treatment Market Size (2015-2020)10.2 Gene Therapies for Cancer Treatment Key Players in Southeast Asia (2019-2020)10.3 Southeast Asia Gene Therapies for Cancer Treatment Market Size by Type (2015-2020)10.4 Southeast Asia Gene Therapies for Cancer Treatment Market Size by Application (2015-2020)11 India11.1 India Gene Therapies for Cancer Treatment Market Size (2015-2020)11.2 Gene Therapies for Cancer Treatment Key Players in India (2019-2020)11.3 India Gene Therapies for Cancer Treatment Market Size by Type (2015-2020)11.4 India Gene Therapies for Cancer Treatment Market Size by Application (2015-2020)12 Central & South America12.1 Central & South America Gene Therapies for Cancer Treatment Market Size (2015-2020)12.2 Gene Therapies for Cancer Treatment Key Players in Central & South America (2019-2020)12.3 Central & South America Gene Therapies for Cancer Treatment Market Size by Type (2015-2020)12.4 Central & South America Gene Therapies for Cancer Treatment Market Size by Application (2015-2020)13 Key Players Profiles13.1 Takara Bio13.1.1 Takara Bio Company Details13.1.2 Takara Bio Business Overview and Its Total Revenue13.1.3 Takara Bio Gene Therapies for Cancer Treatment Introduction13.1.4 Takara Bio Revenue in Gene Therapies for Cancer Treatment Business (2015-2020))13.1.5 Takara Bio Recent Development13.2 Tocagen13.2.1 Tocagen Company Details13.2.2 Tocagen Business Overview and Its Total Revenue13.2.3 Tocagen Gene Therapies for Cancer Treatment Introduction13.2.4 Tocagen Revenue in Gene Therapies for Cancer Treatment Business (2015-2020)13.2.5 Tocagen Recent Development13.3 VBL Therapeutics13.3.1 VBL Therapeutics Company Details13.3.2 VBL Therapeutics Business Overview and Its Total Revenue13.3.3 VBL Therapeutics Gene Therapies for Cancer Treatment Introduction13.3.4 VBL Therapeutics Revenue in Gene Therapies for Cancer Treatment Business (2015-2020)13.3.5 VBL Therapeutics Recent Development13.4 Cold Genesys13.4.1 Cold Genesys Company Details13.4.2 Cold Genesys Business Overview and Its Total Revenue13.4.3 Cold Genesys Gene Therapies for Cancer Treatment Introduction13.4.4 Cold Genesys Revenue in Gene Therapies for Cancer Treatment Business (2015-2020)13.4.5 Cold Genesys Recent Development13.5 Genprex13.5.1 Genprex Company Details13.5.2 Genprex Business Overview and Its Total Revenue13.5.3 Genprex Gene Therapies for Cancer Treatment Introduction13.5.4 Genprex Revenue in Gene Therapies for Cancer Treatment Business (2015-2020)13.5.5 Genprex Recent Development13.6 Momotaro-Gene13.6.1 Momotaro-Gene Company Details13.6.2 Momotaro-Gene Business Overview and Its Total Revenue13.6.3 Momotaro-Gene Gene Therapies for Cancer Treatment Introduction13.6.4 Momotaro-Gene Revenue in Gene Therapies for Cancer Treatment Business (2015-2020)13.6.5 Momotaro-Gene Recent Development13.7 MultiVir13.7.1 MultiVir Company Details13.7.2 MultiVir Business Overview and Its Total Revenue13.7.3 MultiVir Gene Therapies for Cancer Treatment Introduction13.7.4 MultiVir Revenue in Gene Therapies for Cancer Treatment Business (2015-2020)13.7.5 MultiVir Recent Development13.8 SynerGene Therapeutics13.8.1 SynerGene Therapeutics Company Details13.8.2 SynerGene Therapeutics Business Overview and Its Total Revenue13.8.3 SynerGene Therapeutics Gene Therapies for Cancer Treatment Introduction13.8.4 SynerGene Therapeutics Revenue in Gene Therapies for Cancer Treatment Business (2015-2020)13.8.5 SynerGene Therapeutics Recent Development13.9 Ziopharm Oncology13.9.1 Ziopharm Oncology Company Details13.9.2 Ziopharm Oncology Business Overview and Its Total Revenue13.9.3 Ziopharm Oncology Gene Therapies for Cancer Treatment Introduction13.9.4 Ziopharm Oncology Revenue in Gene Therapies for Cancer Treatment Business (2015-2020)13.9.5 Ziopharm Oncology Recent Development13.10 Anchiano Therapeutics13.10.1 Anchiano Therapeutics Company Details13.10.2 Anchiano Therapeutics Business Overview and Its Total Revenue13.10.3 Anchiano Therapeutics Gene Therapies for Cancer Treatment Introduction13.10.4 Anchiano Therapeutics Revenue in Gene Therapies for Cancer Treatment Business (2015-2020)13.10.5 Anchiano Therapeutics Recent Development13.11 Celgene10.11.1 Celgene Company Details10.11.2 Celgene Business Overview and Its Total Revenue10.11.3 Celgene Gene Therapies for Cancer Treatment Introduction10.11.4 Celgene Revenue in Gene Therapies for Cancer Treatment Business (2015-2020)10.11.5 Celgene Recent Development13.12 Celsion10.12.1 Celsion Company Details10.12.2 Celsion Business Overview and Its Total Revenue10.12.3 Celsion Gene Therapies for Cancer Treatment Introduction10.12.4 Celsion Revenue in Gene Therapies for Cancer Treatment Business (2015-2020)10.12.5 Celsion Recent Development13.13 Bluebird Bio10.13.1 Bluebird Bio Company Details10.13.2 Bluebird Bio Business Overview and Its Total Revenue10.13.3 Bluebird Bio Gene Therapies for Cancer Treatment Introduction10.13.4 Bluebird Bio Revenue in Gene Therapies for Cancer Treatment Business (2015-2020)10.13.5 Bluebird Bio Recent Development14 Analysts Viewpoints/Conclusions15 Appendix15.1 Research Methodology15.1.1 Methodology/Research Approach15.1.2 Data Source15.2 Disclaimer15.3 Author Details

About Us:

QYResearch always pursuits high product quality with the belief that quality is the soul of business. Through years of effort and supports from huge number of customer supports, QYResearch consulting group has accumulated creative design methods on many high-quality markets investigation and research team with rich experience. Today, QYResearch has become the brand of quality assurance in consulting industry.

See the original post:
Gene Therapies for Cancer Treatment Market Growth by Top Companies, Trends by Types and Application, Forecast to 2026|Takara Bio, Tocagen, VBL...

Recommendation and review posted by Bethany Smith

Cryopreservation has become an indispensable step in the daily routine of scientific research as well as in a number of medical applications, ranging from assisted reproduction and transplantations to cell-based therapies and biomarker identification. It is hardly possible to picture todays scientific and medical advancements without this technique.The successful development and implementation of all the therapeutic and scientific discoveries involving cryopreservation relies on the correct and safe translation of the method from the laboratory to the clinical and manufacturing scale.

With the need to correctly use this technique, more research is focusing on optimizing cryopreservation methods and investigating what the long-term effects and consequences are on the physiology of the cryopreserved material.

An important part of cell therapy research is focused on adult stem cells (ASCs). ASCs can be derived from different sources such as peripheral blood, bone marrow or adipose tissue and display strong promises because of their capacity to differentiate into any cell type of the human body.In recent work3, the team of Michael Pepper at the Institute for Cellular and Molecular Medicine in Pretoria, South Africa, explored the effects of cryopreservation on the differentiation ability of adipose tissue-derived stem cells (ADSCs). After analyzing gene expression of key adipogenic genes and the degree of differentiating cells, characterized with high levels of CD36 and intracellular lipid droplets, the scientists reported that slow freeze cryopreservation of cells shortly after their isolation causes no alterations on their ability to differentiate. Pepper is convinced of the necessity to perform such analysis when cryopreserving important cell pools: It is critical to do a post-thaw analysis of cell function to determine how the cryopreservation may have affected the cells.His team is analyzing the effects of cryopreservation on other cell types largely used in cell-based therapies such as hematological stem cells and peripheral blood mononuclear cells (PBMCs). Although they didnt observe major alterations in terms of immunophenotyping or the post-thaw proliferation of the cells, Pepper expresses his concern that more subtle characteristics might be affected.

Correct cryopreservation of cells intended for therapeutic use is crucial. This is very important particularly as cells may persist for a long time in the recipient. This area of cell therapy research definitely requires more attention, Pepper says. Moreover, his words reflect on the need to evaluate not only the direct post-thaw recovery, but to look deeper into the late-onset effects cryopreservation might have and ensure that transplanted cells have preserved their therapeutic properties.

In contrast to slow freezing, vitrification relies on the fast freezing of the material by putting it in high concentration of cryoprotectant and in contact with liquid nitrogen. This method allows the direct transition of water from liquid to solid state without crystal formation. The highly concentrated cryoprotectant prevents ice formation and therefore there is no need for slow cooling.

Although vitrification has a great potential, there are a couple of parameters that are a point of concern. The quick and drastic freeze is possible thanks to the high concentration of cryoprotectant, but the latter is also associated with higher toxicity. In some cases, an additional limitation is the direct contact of the sample with liquid nitrogen which is a predisposition for viral or bacterial contamination.The team of Christiani Amorim at the Institute for Experimental and Clinical Research in Louvain, Belgium, is approaching the challenges of vitrification in the context of ovarian auto-transplantation. Ovarian auto-transplantation consists of preserving a piece of ovarian tissue with active follicles from the pre-therapeutic ovary of a cancer patient, as chemotherapy often has damaging effects on the reproductive organs. This tissue sample will be conserved and auto-transplanted onto the patients ovary when she has recovered and wishes to become pregnant.In their recent research4, the authors used stepped vitrification, in which the concentration of the cryoprotectant is gradually increased while simultaneously temperature decreases. This avoids ice crystal formation and also prevents cryoprotectant toxicity.Although stepped vitrification has previously given good results in bovine ovarian tissue5, this was not the case for human ovarian tissue. The scientists didnt detect normal follicles following thawing and linked this to high cryoprotectant toxicity. Indeed, they observed all signs of dimethyl sulfoxide (DMSO)-related cell membrane damage: significant organelle damage, cell membrane disintegration and apoptosis. These observations imply on the variability of outcomes that the method could give when applied to the same type of tissue but from a different organism.Amorim is positive about the future of their method and recognizes the need for further research on the topic: I can see a great potential in the stepped vitrification approach, but I also believe that there is a lot we still need to learn before thinking about using it as method of choice for human ovarian tissue cryopreservation. The high cryoprotectant concentration that should be applied in this approach is my first concern. () Our study clearly showed that 50% DMSO is too high, so we need to try lower concentrations or combine it with other cryoprotectants.

Read the original:
Freezing Life: The Current Trends in Cryopreservation - Technology Networks

Recommendation and review posted by Bethany Smith

Minneapolis May 1, 2020 (Thomson StreetEvents) -- Edited Transcript of Bio-Techne Corp earnings conference call or presentation Thursday, April 30, 2020 at 1:00:00pm GMT

* Charles R. Kummeth

* James T. Hippel

Robert W. Baird & Co. Incorporated, Research Division - Senior Research Analyst

Stifel, Nicolaus & Company, Incorporated, Research Division - MD & Senior Analyst

* Jacob K. Johnson

Janney Montgomery Scott LLC, Research Division - MD, Head of Healthcare Research & Senior Equity Research Analyst

SVB Leerink LLC, Research Division - MD of Life Science Tools & Diagnostics and Senior Research Analyst

Good morning, and welcome to the Bio-Techne earnings conference call for the third quarter of fiscal year 2020. (Operator Instructions) I would now like to turn the call over to David Clair, Bio-Techne's Senior Director, Investor Relations and Corporate Development.

David Clair, Bio-Techne Corporation - Senior Director of Corporate Development [2]

Good morning, and thank you for joining us. On the call with me this morning are Chuck Kummeth, Chief Executive Officer; and Jim Hippel, Chief Financial Officer of Bio-Techne. Before we begin, let me briefly cover our safe harbor statement. Some of the comments made during this conference call may be considered forward-looking statements, including beliefs and expectations about the company's future results as well as the potential impact of the COVID-19 pandemic on our operations and financial results. The company's 10-K for fiscal year 2019 identifies certain factors that could cause the company's actual results to differ materially from those projected in the forward-looking statements made during this call. The company does not undertake to update any forward-looking statements as a result of any new information or future events or developments. The 10-K as well as the company's other SEC filings are available on the company's website within its Investor Relations section. During the call, non-GAAP financial measures may be used to provide information pertinent to ongoing business performance. Tables reconciling these measures to most comparable GAAP measures are available in the company's press release issued earlier this morning on the Bio-Techne Corporation website at http://www.bio-techne.com. I'll now turn the call over to Chuck.

Charles R. Kummeth, Bio-Techne Corporation - CEO, President & Director [3]

Thanks, Dave, and good morning, everyone. Thank you for joining us for our third quarter conference call. This has been an extraordinary quarter. First, I want to thank all the employees, suppliers and partners of Bio-Techne for their exemplary service as we have worked through the COVID-19 pandemic. We are happy to report that we have no coronavirus cases in any of our global sites and implemented proactive safety measures very early in the crisis in February to protect our employees. Our balance sheet is sound with a very strong cash position and low leverage. We have not conducted any restructuring or furloughs to date, easing the minds of our employees and enabling them to focus on serving our life science research customers and clinical diagnostics partners.

While COVID-19 negatively impacted our business this quarter, primarily due to the temporary shutdown of academic labs, we are playing a critical role in the global fight to develop tests and cures for the virus. Overall, we were having a very strong Q3 until the virus pandemic had a pronounced impact on our business in mid-March. But even so, we ended the quarter with 6% organic growth. Adjusting for the impact of coronavirus in the quarter, we estimate our organic growth would have been closer to 9%.

Our team also delivered incredibly strong operational results in Q3, with adjusted operating margins expanding year-over-year by 130 basis points to 36.5%, ahead of schedule and with strong cash flow.

Now I'll get into some details of the quarter. Starting with our performance by geography, the North American market was very strong with low double-digit growth organically in the quarter. Biopharma growth in the region was over 20% while academia increased mid-single digit. In general, both end markets were impacted by COVID-19-related shutdowns starting in mid-March, although our academic market experienced a disproportionate negative impact from the virus. The good news is that these are academic labs, not large industrial manufacturing lines. As researchers return to the lab and get back to work, we anticipate utilization of our consumables will snap back very quickly.

Overall, biopharma research activity has been less impacted by the virus, with many labs continuing to operate at varying capacities. I don't believe we are alone in our belief that once this pandemic is under control, life sciences research will likely increase significantly. It appears everyone in society from governments through the private sector now knows what an antibody is, this can only be good for our industry. With current stay-at-home policies, many of our customers are spending much more time -- of their time online. Therefore, we continue to focus on our digital marketing efforts that have driven significant increases in website traffic across our brands over the past couple of years. Search engine optimization, continual refinement of our website and digital advertising will remain a growth lever for the company going forward and will be even more important as a differentiator in the current pandemic environment. We have never done more webinars and digital projects to reach out to our customers. For example, we recently held an Exosome Diagnostics webinar for urologists, many of whom are working from home now and had over 100 participants.

Moving on to Europe, which was positioned for a sequential recovery until the virus hit, finished the quarter with revenue down from last year by 7%. Here, we had a very strong quarter in Biologics as well as with our Simple Plex platform, which is seeing strong growth in COVID-19-related patient care decisions by monitoring cytokine storm onset and progression. However, this strength was not enough to offset the March shutdowns in academia, which especially impacted our Simple Western, Genomics, assay and reagent businesses in the quarter. It is still uncertain when European labs will begin to open back up, but we're expecting this to be country-by-country process.

So far, in April, our German business is showing signs of an initial recovery, with Italy potentially not far behind. Our largest business is in the U.K., which is likely to be a month or so behind Germany in the recovery process.

Finally, we had a surprisingly strong Q3 in Asia. Given the complete shutdown in China in late February, we were prepared for a quarter of negative organic growth in this country, but finished with positive organic growth in the mid-single digits. This fantastic finish reflects the outstanding work done there by the local team. Our employees in China are back to work serving -- servicing a research market that has largely turned back on and expecting to revert to their long-term trend of double-digit growth in Q4. The rest of Asia also performed extraordinary well in Q3 with growth in the mid-teens. However, many of these countries, including Japan, Korea and India are currently in varying states of lockdown and expected to remain so for most of Q4. Accordingly, we are expecting double-digit negative growth outside of China in Q4.

Before I turn the call over to Jim for the financial review, I would like to provide some more detail on the initiatives that our company is working on to help our customers develop tests and find remedies for COVID-19. I will also provide an update on some of the strategic growth initiatives that will have the largest impact to our company for years to come.

Starting with our COVID-19 initiatives, we are experiencing significant demand in ramping production of our proteins and antibodies used in coronavirus research, including reagents that are components in serological assays. Also, we are working with several health care providers in perfecting antibody assays using the traditional ELISA platform that can detect an individual exposure profile to COVID-19, something that many health experts believe will require mass testing before world economies can resume any sort of pre-COVID-19 normalcy. Also, as I mentioned in my commentary regarding Europe, we've experienced significant global interest in demand to leverage Ella as an automation tool for the detection and monitoring of COVID-19 patients that are potentially experiencing cytokine release syndrome. This dangerous condition represents a critical and potentially fatal point in disease management.

In our Genomics division, we are supplying COVID-19 RNAscope Pro for virus detection in tissue, allowing researchers to confirm the organs that are impacted by this virus. And in Exosome Diagnostics, we have validated and preparing to perform COVID-19 real-time qPCR testing at our labs in both Munich, Germany and Waltham, Massachusetts. Following the implementation of processes and instruments to automate the test, we'll be capable of processing over 200 samples a day, and we can ramp further after that. This lab-developed test will provide rapid and reliable detection of patients with active COVID-19 infections.

These are just a few examples of how practically every division of our company has pivoted resources to find innovative solutions for COVID-19 and participate on a global level to help eradicate this horrible virus. We are uniquely positioned to provide reagents and assays for all aspects of COVID-19 research and diagnostics, and our mission thrives in helping solve these types of problems.

Next, I will provide an update on 2 of our important strategic growth platforms, cell and gene therapy as well as Exosome Diagnostics. Starting with cell and gene therapy, we continue to make progress on the construction of our new dedicated GMP protein factory. Construction of the facility remains on track to provide GMP proteins in large-scale to our cell and gene therapy customers by the second half of fiscal 2021. We are very encouraged by initial interest in demand from biopharma customers as we actively market our coming GMP protein production capabilities and capacities. In fact, during the quarter, we executed our first large-scale GMP protein supply agreement. This customer is still making its way through the regulatory approval process for its therapy, making the GMP protein with a revenue likely in fiscal '21.

Many other customers have been engaging us with interest in long-term supply agreements to ensure continuity of supply for their present clinical studies and to meet their future commercial needs. In the meantime, our GMP portfolio has been growing at a rapid pace with a number of immune cytokines being used to grow cells in clinical trials.

Also within our cell and gene therapy business, we have begun operationalizing the joint venture with Wilson Wolf and Fresenius Kabi that we announced last quarter. As a reminder, this commercial consortium offers a complete and simplified cell and gene therapy workflow solution using products from all 3 parties. During Q3, we focused on establishing a unified sales structure, a customer-facing website and point-of-sale and creating impactful marketing collateral, featuring all 3 parents offerings. In addition, the emerging interest in natural killer cell therapies for oncology has been demonstrating some great clinical potential. And the JV is well positioned for the renewed natural killer interest, leveraging our GMP proteins, cloud, media and PC buster platforms for cell genetic engineering of difficult to grow natural killer cells.

Now an update on Exosome Diagnostics and the ExoDx prostate test. There were several positive developments in Q3, and there is still much to do to make sure this noninvasive prostate cancer test becomes available to all patients with heightened PSA levels who are contemplating a more expensive, more risky and painful tissue biopsy. Following the final local coverage decision, or LCD, from our medical -- Medicare Administrative Contractor or MAC, National Government Services, NGS, we have been billing Medicare for applicable patient tests and are receiving steady reimbursement for tests submitted to this important payer. Recall that our -- we are currently preparing for the reconsideration process with our MAC, NGS to get the LCD more accurately mirroring the more inclusive NCCN Guidelines, which will expand the potential market size of the test. Based on our prior experience, we anticipate a public comment period to take place in the summer, followed by a final LCD in the fall.

Continuing on the reimbursement front, we announced the receipt of an unlimited 10-year reimbursement contract with General Services Administration, or GSA, making the ExoDx prostate test available to more than 140 government entities, including the Veterans Administration health care system. Our conversations with private payer community continue to progress, but many payers want to see a clinical utility study published prior to issuing favorable coverage decisions. We expect such publication in a leading peer-reviewed urology journal within the next couple of months. The clinical utility study shows improved patient compliance to either defer prostate biopsy or proceed with biopsy compared to the control arm when implementing the ExoDx prostate test in clinical practice. Due to this increased compliance to proceed with biopsy, physicians detected 30% more cases of clinically significant or high-grade prostate cancer compared to the standard of care control alarm. Implementing EPI not only saves the health care system money by avoiding unnecessary biopsies but also increases compliance among patients that need biopsies, leading to higher cancer detection rates. We anticipate the clinical utility and economic value shown in this study will resonate with the private payer community, increasing the frequency of our conversations and strengthening the argument for favorable coverage decisions.

Currently, the coronavirus pandemic has had an impact on a number of individual-seeking wellness business which in turn has had an impact on the number of PSA tests and ultimately the number of ExoDx prostate tests conducted. We saw this play out during the month of March, and the decline in test has continued into April. We responded by recently launching an at home collection kit for our ExoDx prostate test, enabling men who are sheltering in place and thus unable to see a health care professional to know if a biopsy should be prioritized. The solution was launched with a patient-targeted marketing strategy, including Search Engine Optimization, a Facebook campaign and webinars to drive awareness that patients do not need to go into the urologist's office to have access to this valuable test. We believe the flexibility of providing a urine sample at the convenience of the patient will be yet another key differentiator of the ExoDx prostate test from the competition.

With a pipeline of additional tests, companion diagnostic applications and partnership opportunities, there are multiple avenues to create value with Exosome Diagnostics. We have a few partnerships in place and are in active discussions with several diagnostics and biopharmaceutical companies for potential applications of Exosome Diagnostics technology. In summary, I'm very proud of the way our team executed in our fiscal third quarter, especially considering the global challenges created by COVID-19. The pandemic creates some near-term challenges, but also some near-term opportunities as we deploy reagents to enable vaccine and therapeutic discoveries and diagnostic solutions. Stepping back from the current environment, our pillars for growth are fully in place. We remain in the very early innings of realizing a tremendous liquid biopsy and cell and gene therapy potential opportunities. And our proteomic and genomic and analytical tools remain extremely well positioned in very underpenetrated markets. I firmly believe that the environment for life science research and diagnostics will be even stronger as we emerge from this pandemic, and we have the financial strength and product portfolio to capitalize on these opportunities. With that, I'll turn the call over to Jim.

--------------------------------------------------------------------------------

James T. Hippel, Bio-Techne Corporation - Senior VP of Finance & CFO [4]

--------------------------------------------------------------------------------

Thanks, Chuck. I will provide an overview of our Q3 financial performance for the total company, and provide some additional color on the performance of each of our segments, and give some initial thoughts on potential scenarios for our Q4.

Starting with the overall third quarter financial performance. Adjusted EPS was $1.39 versus $1.21 one year ago, with foreign exchange positively impacting EPS by $0.07. Most of the foreign exchange impact was due to nonoperating foreign exchange related to our cash pooling arrangement. GAAP EPS for the quarter was $0.92 compared with $1.15 in the prior year. The biggest driver for the decrease in GAAP EPS was $400,000 in realized and unrealized gains on our investment in ChemoCentryx compared to the $12.3 million in unrealized gains in the prior year. Q3 revenue was $194.7 million, an increase of 5% year-over-year on a reported basis. Organically, revenue increased 6%, with foreign exchange translation having an unfavorable impact of 1% and less than 1% growth contribution from acquisitions.

By geography, the U.S. grew in the low double digits, while Europe declined approximately 7% and China grew mid-single digits. As for the rest of Asia, organic growth was in the mid-teens. By end market, which excludes Asia, our Diagnostics division and other OEM customers, biopharma growth was in the low teens, while academic sales decreased by the low single digits.

Moving on to the details of the P&L. Total company adjusted gross margin was 71.5% in the quarter compared to 71.3% in the prior year. The increase was due to volume leverage, partially offset by foreign currency headwinds and, to a lesser extent, the B-MoGen acquisition. Adjusted SG&A in Q3 was 26.8% of revenue, a 90 basis point improvement compared to the prior year, with volume leverage partially offset by investments in our core business to drive near and long-term growth. R&D expense in Q3 was 8.2% of revenue, 20 basis points lower than the prior year, primarily due to volume leverage. The resulting adjusted operating margin for Q3 was 36.5%, an increase of 130 basis points from the prior year period and 310 basis points higher than our second fiscal quarter result.

Looking at our numbers below operating income. Net interest expense in Q3 was $4.2 million, decreasing $0.7 million compared to the prior year period. The decrease was due to a substantial reduction of our bank debt during the first half of fiscal 2020. Our bank debt on the balance sheet as of the end of Q3 stood at $420 million. Other adjusted nonoperating income was $3 million for the quarter compared to $1.5 million of other expense from Q3 last year, primarily reflecting the foreign exchange impact related to our cash pooling arrangements. For GAAP reporting, other nonoperating income includes realized and unrealized gains from our investment in ChemoCentryx.

Moving further down the P&L, our adjusted effective tax rate in Q3 was 21.3%, and we are anticipating Q4's rate to be closer to our year-to-date adjusted tax rate of 21.6%.

Turning to cash flow and return of capital. $49.5 million of cash was generated from operations in the quarter, up 25% over Q3 of last year. We also added to our cash position by monetizing approximately $30 million of our ChemoCentryx investment during the quarter. In Q3, our net investment in capital expenditures was $9.3 million, mostly driven by construction of our new GMP protein factory, which remains on schedule for completion by the end of the calendar year. And during Q3, we returned capital to shareholders with $12.3 million of dividends and approximately $50 million of share buybacks, leaving 39.4 million average diluted shares outstanding at the end of the quarter.

Next, I'll discuss the performance of our reporting segments, starting with the Protein Sciences segment. Q3 reported sales were $145.5 million, with reported revenue increasing 6%. Organic growth was also 6%, with foreign exchange having an unfavorable impact of 1% on revenue growth and acquisitions contributing 1% to revenue growth. Growth in the segment was driven by strong demand for protein reagents and both our Biologics and Simple Plex instrument platforms, partially offset by the impacts of COVID-19 customer shutdowns. Operating margin for the Protein Sciences segment was 44.7%, a decrease of 40 basis points year-over-year due to unfavorable foreign exchange and the B-MoGen acquisition.

Turning to the Diagnostics and Genomics segment. Q3 reported sales were $49.4 million, an increase of 5% from the prior year. Organically, revenues also grew 5%, with foreign exchange translation having an immaterial impact on revenue. Our Genomic divisions RNAscope contributed solid double-digit growth in the Americas, but this growth was partially offset by COVID-19 customer shutdowns in China as well as Europe. Exosome Diagnostics contributed approximately 3% to the segment's growth in Q3, with Medicare collections over $1 million following the final lab coverage decision by NGS in December.

Moving on to operating margin for the Diagnostics and Genomics segment, at 14.3%, the segment's operating margin improved from 7.6% reported in the prior year. The increase reflects a near double in operating profit due to less dilution from Exosome Diagnostics, volume leverage from our Genomics division and productivity gains from our diagnostic tools division. As many of you know, it is not our policy to provide specific annual or quarterly guidance, but instead provide some high level color, and how we anticipate our business to perform relative to our longer-term strategic plan. Clearly, the evolving COVID-19 pandemic and related customer impact was not contemplated in our long-term strategic plan nor a shorter-term annual plan. Therefore, I thought it'd be helpful to provide some color on the impact we've seen from COVID-19 so far in April and possible scenarios of how it could play out for our Q4.

Let me begin with the headwinds we've seen so far in April. With most academic institutions shut down in the Americas and Europe and some nonessential research put on pause by biopharma, our run rate in reagent and assay businesses in these geographies has dropped off considerably from prior year levels in the range of minus 20% to minus 40%, depending on the product line and specific regions. Encouragingly, there have been recent talk in both Europe and the U.S. about slowly and systematically opening up universities for professors to conduct their research, even if uncertain about students returning in the fall. Obviously, when it is safe to do so and this talk becomes action, our run rates will gradually improve as researchers return to their labs.

Chuck has already mentioned the headwinds we face in Asia outside of China due to reoccurrences of the virus in places like Japan and Singapore as well as the full walk-down in India. However, China is looking like a nice tailwind for us in Q4 with growth rebounding well into the double digits. Other tailwinds for Q4 include our Biologics and Simple Plex instrument product lines. Just as they led our growth in Q3, these platforms have started out just as strong in April, and we expect a high demand for them to continue, especially the Simple Plex platform, which is specific to COVID-19 treatment-related needs.

And finally, we should experience some tailwinds from all the other COVID-19 initiatives that Chuck previously discussed. But as many of these products are still currently under development, knowing exactly how much they will contribute to Q4 revenue is difficult to project. All this being said, our best estimate of how these variables will play out, results in a Q4 organic growth being somewhere in the range between minus 10% and minus 20%. Because we do not anticipate that our higher-margin reagent business so -- because we do anticipate that our higher-margin reagent business will be more severely impacted by the shutdown. This will likely have a material negative impact on gross margins for the quarter. Our operating margin will likely be further pressured by our operating cost base being relatively flat to prior year on much lower revenues. Right now, we are assuming that we have seen the worst impact from COVID-19 in April, and that conditions will gradually improve from here. And when they do, we will emerge as an even stronger company as we continue down our path of executing on our strategic plans and key growth initiatives.

In summary, despite unprecedented conditions created by COVID-19, we delivered 6% organic growth in the third quarter. We are in a position of financial strength with cash and short-term investments in excess of $250 million and a leverage ratio of just 1.4x. One thing this global pandemic has clearly highlighted is the need for life sciences research, and we believe that global demand for our tools, which enable drug discovery and production, genomic and proteomic analysis and diagnostic solutions will emerge from this pandemic stronger than when it began. Our global teams and product portfolio are positioned to capture that stronger demand in addition to our original growth plans when the virus-related headwinds subside. With that, that concludes my prepared comments, and I will turn the call back over to the operator for the line for questions.

================================================================================

Questions and Answers

--------------------------------------------------------------------------------

Operator [1]

--------------------------------------------------------------------------------

(Operator Instructions) Our first question comes from the line of Puneet Souda with Leerink Partners.

--------------------------------------------------------------------------------

Puneet Souda, SVB Leerink LLC, Research Division - MD of Life Science Tools & Diagnostics and Senior Research Analyst [2]

--------------------------------------------------------------------------------

So Chuck, first of all, congrats on a solid quarter here despite the disruption. And it's good to see the resiliency in China and very tough compares that you had already from last year. So in April, if you could -- thanks for the comments, but I wanted to understand how is -- how do you view the recovery here for academic and biopharma segments, just sort of given the behavior academic has been impacted more heavily? Any sort of early signs in the latter part of April that you're seeing here that give you a better picture into May in either of the biopharma segments or the academic segments? Then I have a couple of questions.

--------------------------------------------------------------------------------

Charles R. Kummeth, Bio-Techne Corporation - CEO, President & Director [3]

--------------------------------------------------------------------------------

Sure. Well, biopharma is still pretty resilient. And I think as we talked about, I think we have some upside even there with a lot of instrumentation that is hotter than ever. Biologics is doing really well. We are starting to see that drift into cell and gene therapy qualification. So we expect that platform to continue to do well. Simple Western is a little bit under pressure because unlike biologics, it's kind of 50-50 with academia. So a little softer. It's anyone -- yes, when things start opening up. I mean, you're hearing it already state-by-state, including lawsuits. There's a lot of fatigue out there. People want to go back to work. And with that, labs will reopen. And I think people are also getting creative with what they can start doing. And then we are seeing more activity online and a lot of webinar activity. And so end of April, maybe not so much material. By May, we're hoping some. Certainly, the -- in Q1, we expect to see things starting to come back. So we're hoping this is more of a V versus a long U. And that's kind of where we're looking at it.

--------------------------------------------------------------------------------

James T. Hippel, Bio-Techne Corporation - Senior VP of Finance & CFO [4]

--------------------------------------------------------------------------------

Another way -- another way to think about it too is we're gradually opening up the economy to go back to work. A lot of it is going to require social distancing practices while at work. There's an argument that can be made that in labs, in general, it's potentially easier for those practices to be put in place, perhaps in other types of industries. So another reason why we think that once the economy does, it starts to gradually reopen up life science research will be one of the earlier phases of that.

--------------------------------------------------------------------------------

Charles R. Kummeth, Bio-Techne Corporation - CEO, President & Director [5]

--------------------------------------------------------------------------------

Well, I know in our own labs, which is remarkably a lot like every other lab, that we're pretty social distant anyway. People aren't just on top of one another in these labs. So I think there's a good -- it's just going to take time for people to acknowledge that and kind of get into it. But the world is going to be different. There will be masks that work for quite some time, I'm sure, and a lot of different things. But a lot of our people wore that stuff and gloves anyway. So I don't think there's been too much issue there. Pretty amazing to see China just kind of turned back on. If there any good data point that if you come back and follow good social distancing, everybody wears a mask, it looks like there's a good promise that we don't have a reescalation. So anyone guess over what happens with wave 1, 2, 3 over the next coming years. I'm sure there'll be some of that, too, but we're very, very optimistic that when this is all done, the paltry $40 billion NIH budget is going to go up dramatically. So it's a rounding year compared to what's been lost and what's been thrown around here for stimulus. So research is going to go up, and we're perfectly positioned. And by the way, we're going to be plugging some of this hole too with COVID-19 projects, which we alluded to. I wish we had more positive press release type news to give you, but we're working on many projects here than some that could really scale. But it's too early to tell you. If and when we come out with tests, serological or other, you'll know that it will have the R&D systems brand-new quality behind them. So it won't -- it will be something remarkable and with high sensitivity and specificity, and we're working on technology platforms around what we're good at, antibodies and proteins that can be differentiated from everybody out there and who is chasing the stuff. So stay tuned, more to come.

--------------------------------------------------------------------------------

Puneet Souda, SVB Leerink LLC, Research Division - MD of Life Science Tools & Diagnostics and Senior Research Analyst [6]

--------------------------------------------------------------------------------

Okay. That's helpful. So following on that, in COVID research, I know it's tough to quantify this, but do you expect to see any benefit from the $25 billion COVID testing and testing research allocation for the -- as part of the coronavirus relief fund? And what's your expectation here? Just in terms of the portfolio, the breadth of the portfolio that you have, from antibodies to cytokines. I mean, how should we think about what parts of the portfolio are likely to benefit when that NIH -- potential NIH increase that could happen in 2021? And so what parts of the portfolio should we expect to benefit from that because there is some expectation that could be directed more towards infectious diseases versus other traditional oncology research and other areas?

--------------------------------------------------------------------------------

Charles R. Kummeth, Bio-Techne Corporation - CEO, President & Director [7]

--------------------------------------------------------------------------------

Well, it's anyone's guess how much will go one way versus the other in infectious diseases, but in terms of our portfolio, all of it. I can't imagine that there won't be an amazing interest continuing in the proteins that were developed. We're selling a lot of proteins that things are going up a lot in a lot of categories that are used in this research, and also with antibodies. And poly through monos, it's been pretty exciting. We almost can't keep up in some areas. So we're working on scalable solutions that can resupport partners for things like serological. For -- there's been a lot of relaxation with the FDA to try and have something work out there, and there's been some negativity around that. But I can guarantee you that we're on top of this and involved in many fronts and our reagencies are going to do really well. The tools are going to do well. You got to measure this stuff. We are the worldwide leader in ELISA Kits. And ELISA Kit is the best way to do a serologic. It's the cheapest, it's fast. Everybody has automation. So we're a world leader in Luminex with many partners. Luminex is another way to attack a lot of stuff in there. Everyone's got their flavor of these different partnerships and deals. And it's just become so vast. And like we talked about here, when do you see a new $1 trillion plus market open up overnight? And it's -- there are a lot of opportunities here, and we get the best of both worlds to chase the new market, but also do something wonderful for society. We're going to help eradicate this virus. We're involved on more fronts than we can even tell you. In terms of resources pivoted, virtually over 200 employees have been refocused around these projects in the company. And they may not all work out. We may win in some, lose in others or be a fast follower in others, but a lot of it or more, been around a lot of innovation, a long time. And these things always lead the stuff. And the funding is going to trickle down to touch many parts of our business. There's no doubt in my mind. It's hard to quantify right now, but it's going to be -- you got to look beyond Q4 and even Q1. You got to look into next year and the year after, we're going to be stronger than ever with the base business, and we're going to have all this incremental new business on top of it. And then we still have our cell and gene therapy and Exosome Diagnostics platform is just starting to ramp. So for us, it's a better story than ever. As we start looking out 1, 2, 3 years, I mean, in our opinion, in Q3. Our Q3 results just kind of make that indicative. We had a pretty darn good quarter.

--------------------------------------------------------------------------------

Puneet Souda, SVB Leerink LLC, Research Division - MD of Life Science Tools & Diagnostics and Senior Research Analyst [8]

--------------------------------------------------------------------------------

Yes. Last one, if I could ask on China. That was a surprisingly good quarter given sort of compared to what we were heading into. The shape of resiliency that you're seeing there currently, what's your expectation? How long do you think -- I mean, sort of how long is that sustainable? There are some questions being raised on the recurrence of the virus. Obviously, China was ahead of the curve. So what are you hearing from your team on the ground there?

--------------------------------------------------------------------------------

Charles R. Kummeth, Bio-Techne Corporation - CEO, President & Director [9]

--------------------------------------------------------------------------------

Well, we have our whole team in, and we have our management in, too, including our leaders had to go in and go through quarantine to get back in the country. The country has got very, very strict guidelines to get in. So they're not letting anybody in without going through quarantine. So that's a big part of why they're staying safer probably. Everybody is wearing masks, according to our team. If you're -- China is one of those countries where there's a lot of lines in and so social distance up to this point was a very small distance. It's going to change and it is changing. And there's not been a material resurgence. So if there's no resurgence, we think it's, like we said, back to double-digit or higher already this quarter. So nothing but up. If there's a resurgence and there's new rules going in place, we'll have to adjust. But right now, there's nothing to worry about there. I'm frankly, much more concerned about what happens in India. And Japan and Korea are both a little behind the curve right now as well. So although we had a wonderful Q3, it's because really, they were just late to the game of the lockdowns. So as they work through their lockdowns this quarter, we'll have that hit, but hopefully, they'll have the same coming out that China did. But judging what we're seeing in Brazil right now, I don't like seeing that because I think India is really at risk. But -- and that's a big growth platform for not this year per se materially, but looking 5 years out, so it could put some risk into that. But I think Korea and Japan will be fine after a quarter here. And I think China is moving forward. We don't see a real hit. Europe is a slower recovery and it's country-by-country. We were having an outstanding quarter until this hit. And -- but I do think we are on track with a lot of fixing of Europe already, execution-wise, which is in place. And so as they go back to work and labs reopen, I think we'll be in a much better spot in Europe as well. U.S. has been phenomenal. So -- and it remains so. And this is where we're going to see a lot of our COVID-19 incremental growth this quarter and beyond. So hopefully, we'll have nothing to show but extra positive news there. So this is almost sadly the event we're looking for, for Ella. Ella is finally going to see its day. And we're up -- we expect 75% growth in Ella this quarter and probably a double for next year again. So it's going to become a material platform, finally, when this is all said and done. So -- and our ability to get it through all the FDA-related clearances has become easier, obviously. So...

--------------------------------------------------------------------------------

Operator [10]

--------------------------------------------------------------------------------

Our next question comes from the line of Catherine Schulte with Baird.

--------------------------------------------------------------------------------

Catherine Walden Ramsey Schulte, Robert W. Baird & Co. Incorporated, Research Division - Senior Research Analyst [11]

--------------------------------------------------------------------------------

Congrats on a nice quarter. I guess, first, just going back to China. We've heard from other companies that academic and government labs have lagged in terms of reopening. Sounds like you are not seeing that, but just curious to hear, what was the low watermark for activity in China? Was that at 1 point down 20% to 40% as well? And what did that path to recovery look like?

--------------------------------------------------------------------------------

Charles R. Kummeth, Bio-Techne Corporation - CEO, President & Director [12]

--------------------------------------------------------------------------------

It never went negative. And we ended mid-single digit. We were expecting -- we do it like everyone, we got a monthly flash. We had a monthly process, and we were expecting maybe minus 2, minus 3. That's the team was thinking, but it never got down there, and we ended up mid-single digit. I think you're seeing a difference us versus others. And other peers have a lot heavier instrumentation level in their portfolio than we do. We're also not that big, right? So on the reagents front and the things that can back up to speed quick in lab, that's kind of us. So it's a quicker recovery. If you're dealing in mass spec and HPLC and things like that, it's going to be slower. So I think you're seeing some of that. And -- but we were on a nice growth level anyway. So I'm not surprised to see this as long as labs are back at work. The kind of research they do with us with a lot of reagents level testing is something that will snap back quickly, which we also expect to see as well following in Europe and U.S. that's why we made the comments that we did about a fast recovery once labs reopen.

--------------------------------------------------------------------------------

James T. Hippel, Bio-Techne Corporation - Senior VP of Finance & CFO [13]

See more here:
Edited Transcript of TECH earnings conference call or presentation 30-Apr-20 1:00pm GMT - Yahoo Finance

Recommendation and review posted by Bethany Smith

COVIDS WAR ON WOMEN During this plague year, there is almost never good news, only degrees of bad news. Even so, the pandemic has been different (and worse) for girls and women.

Its true that more men are dying than women from Covid-19 around the world but thats not exactly cause for celebration.

Another ambivalent data point: More workplace risk is falling on women, who are more likely to be considered essential workers. The upside to that is still having a job, but at what price? Swedens Foreign Minister Ann Linde pointed out today in a POLITICO interview that 70 percent of those working in health care and elderly care are women.

More of the daily grind tends to fall, on average, on women: From the increased cleaning and chores that come with more time spent in the home, which falls disproportionately to so many female household members, to the extra education and childcare work created through closures of school and day care, where men have also been known, on average, to skimp.

The real-life examples are heartbreaking: Alice Jorge, a woman living with a disability in Belgium who needs support from her sister and a visiting nurse, was recently asked to choose between keeping her Covid-19 positive caregiver or going without professional care. Three women bound to suffer no matter what choices they took.

Domestic violence is up sharply: A new research report by a consortium that includes Johns Hopkins University confirms this: 31 million additional cases of gender-based violence can be expected globally if lockdowns last for an average of six months.

Travel to shelters may be restricted, and a simple phone call to a helpline can itself trigger new violence. Support services are overwhelmed with requests: from a 47 percent increase in calls to Spains national hotline to a 113 percent spike at U.N.-supported hotlines in Ukraine.

We can expect 7 million unplanned pregnancies in 144 low- and middle-income countries, thanks in part to restricted access to contraception, not to mention the 2 million female genital mutilations and countless child marriages projected to increase by the United Nations population agency. The pandemic is deepening inequality, UNFPA Executive Director Natalia Kanem said, slamming the Swiss cheese of a safety net she sees in most countries.

Kanem speaks of childbirth horror stories: pregnant women unable to access caesarian procedures (many of which are unplanned) or blood pressure medication because of redeployed health care resources, or the woman gets to the clinic (and) the midwife isnt there, because theyre also redeployed or sick. Up to two-thirds of maternal and neonatal deaths globally occur because of the absence of properly trained midwives in better times.

During World War II, women on the U.S. homefront think Rosie the Riveter entered the workforce out of a call to sacrifice for the common good. During this pandemic, women are being called back but this time to the frontlines.

Welcome to POLITICO Nightly: Coronavirus Special Edition. Of course Matthew McConaugheys mask says just keep livin. Reach out with tips: [emailprotected] or on Twitter at @renurayasam.

A message from PhRMA:

In these unprecedented times, Americas biopharmaceutical companies are coming together to achieve one shared goal: beating COVID-19. We are working with governments and insurers to ensure that when new treatments and vaccines are approved, they will be available and affordable for patients. Explore our efforts.

THE COVID DOCTRINE For much of the nations 100 days at war with the coronavirus, Donald Trump has been a commander in chief in search of an exit strategy, Adam Cancryn writes. The president has promised the virus will simply disappear, touted unproven treatments as miracle cures and fantasized about a near future of economic resurgence and rapid return to normalcy. Yet as the White House shifts its focus away from the public health response and toward rebuilding an economy ravaged by the pandemic, there remains little clear sense even within his own administration of how close the U.S. is to victory, and what winning the war even looks like.

PINS AND NEEDLES Our executive health editor Joanne Kenen emails: Theres some good news on the vaccine front including word that the country is getting a new vaccine leader. Peter Marks has emerged as the Trump administrations unofficial vaccine czar (minus the cross and pearls) at the FDA, filling in the gap created by the abrupt ouster of Rick Bright from the Biomedical Advanced Research and Development Authority. Marks will advise BARDA and other agencies on vaccine and gene therapy approval, health care reporter Sarah Owermohle reports.

News of Marks growing involvement comes amid a spate of heartening though still, we cant emphasize enough, very preliminary news about vaccine development, here and abroad. Oxford has a candidate vaccine thats safe in humans; its still testing whether it can create a strong enough immune response to combat the coronavirus. Three other companies have announced accelerations of clinical trials, though widespread availability in the best possible scenario is still months away.

Even if we get a vaccine, Joanne writes, big questions have to be answered.

Who gets it second? First responders will get it first. But how are we going to define a first responder? Anyone who works at a hospital? Only doctors and nurses? Doctors in the community? Police? Firefighters? The military?

But then who gets it second? The elderly and immune compromised because they are vulnerable? The young and healthy because they transmit it? Essential workers because theyre essential? The well-connected? And who decides?

Its possible several vaccines will come on the market at around the same time in different countries, so there could be multiple answers to this question. But this is going to be a huge bioethical knot, colliding with geopolitics. Theres no guarantee that a U.S. company will get to market first and if the World Health Organization has a role in vaccine allocation, we can anticipate some obvious conflicts.

How effective is it? If we get a good but not great vaccine like the seasonal flu shots it will still reduce transmission, but it wont wipe out the virus completely. Well still have to deal with Covid-19, though on a more manageable scale.

Who pays for it? Even if insurers, governments or, in countries other than our own, national health systems pay for immunization, the costs can be passed on indirectly through higher taxes or higher premiums.

How much does it cost? Some of the companies say they dont plan to make a profit, but vaccines are expensive. In the U.S., Trump has largely shunned national approaches, leaving states to fend for themselves as they try to acquire lab testing supplies, protective gear, ventilators and other essential pandemic-fighting goods. A similarly fragmented approach could make vaccine acquisition more expensive and complicated.

How do we make enough of it? One of BARDAs roles is to help ramp up production, and theyve started addressing this. But to make 7 billion vaccines, enough for everyone around the globe, will require commitment, creativity and cooperation that the world hasnt been very good at of late.

How fast will poor countries get access? Good question.

Will the anti-vaxxers take it? Well see. Best guess is that some will, and some wont, because not everybody who opposes vaccines does so for the same reasons or with the same intensity. Some people who dont want their child to get a measles shot may weigh the costs and the benefits differently for a coronavirus vaccine. Amid rising fears of bioterrorism after 9/11, a poll found deep but not overwhelming support for a smallpox vaccination campaign. But that was a hypothetical threat. This one is all too real.

A SMALL BREAKTHROUGH More than three decades ago, researchers made their first big breakthrough against HIV, when they showed that the drug AZT could slow the progression of the virus. Its a moment that Anthony Fauci compared to todays results about the drug remdesivir, which a clinical trial showed could help Covid patients recover more quickly.

Faucis reference to AZT was a bit like a secret code, Sarah Owermohle tells us. He was suggesting that the remdesivir results were a breakthrough, but a modest one. AZT is the shorthand for azidothymidine, a drug that won FDA approval in March 1987, when HIV patients were desperate for any treatment even one with rough side effects that was dogged by questions about whether it actually extended life. It took another decade before the development of drugs that turned HIV from a death sentence into a chronic condition.

HIV and Covid-19 are complex, but distinctly different, viruses, and drug development times are a lot faster now than they were in the 1980s and 90s. But Faucis implication was clear: Remdesivir could be a good first step in fighting Covid, but probably isnt a miracle drug.

A SICK ECONOMY The U.S. economy shrank at a 4.8 percent annual rate last quarter as the pandemic shut down much of the country. A huge percentage of the decline came from the health care industry, with a halt in elective procedures harming profits.

CLAIMS DENIED As businesses in Georgia, Texas and other states throw open their doors, many employees are scared that their employers arent taking proper health precautions. Yet if they refuse offers to return to their jobs theyll be ineligible for unemployment, reporter Megan Cassella tells us.

Trump has declared meatpacking plants essential businesses even as they spawn outbreaks across the country. Frontline health workers are having trouble getting masks, gloves, gowns and other protection equipment, so what hope do nail salons and restaurants have of getting the gear they need?

But for now, Covid fears arent a valid reason not to go back to work.

Some states are trying to take steps so that workers who feel unsafe arent forced to choose a paycheck over their health. Colorado and New York are looking at how to give workers more flexibility. In Georgia, the state labor agency is encouraging employers to negotiate back-to-work plans with employees so that if a business partially reopens, workers who feel unsafe can continue to collect unemployment. In Texas, advocates are asking the workforce commission to add voluntarily leaving work due to COVID-19 as a valid reason to claim assistance.

But other states, like South Carolina and Tennessee, are telling workers they will lose unemployment aid the same week they turn down an offer.

Even in boom times, states reject a high share of unemployment claims. Well probably learn Thursday that another 3.5 million people filed for unemployment assistance last week. Thats on top of the 26 million whove already lost their jobs in the past five weeks.

Our question for readers this week: Seeing any interesting, fun or meaningful signs related to the coronavirus? Snap a photo sometime this week and send it to Renu at [emailprotected], and well share the best ones on Friday.

GRAND OLD PACHYDERM Matt Wuerker dives into an old question on partisan symbols in the latest edition of Punchlines: Why is the elephant the symbol of the Republican Party?

MASS HYSTERIA Italian politicians clash with the Catholic clergy at their own peril, and Prime Minister Giuseppe Conte has risked doing just that by keeping churches closed because of coronavirus. The prime minister's decision to extend the ban on all religious ceremonies until further notice, except for funerals, has infuriated religious officials. When the lockdown started, most priests quietly accepted the need to suspend services and found alternative ways to connect with their flocks, such as holding ceremonies by video or taking confession by the roadside. But now that other places are gradually reopening, the clergy don't see why they should be last on the list.

82,000

The number of job losses forecast in the bus industry, according to a report released last week by the American Bus Association. The industry could see losses of up to $14 billion. Many of the 3,000 private bus companies in the U.S. are small, serving a range of uses from taking kids to school, sporting events and field trips, ferrying seniors on weekend getaways and connecting small towns with major destinations. (h/t transportation reporter Tanya Snyder)

Portuguese army chief of staff Gen. Jos Nunes da Fonseca attends a briefing of school workers on disinfection procedures. | Armando Franca/AP Photo

DEEP FRIED STATE Belgium, the North Sea homeland of moules frites and mayonnaise, is the world's biggest exporter of frozen fries, but it has been hammered by the pandemics trade slowdown. The Belgian potato industry has warned that more than 750,000 tons of potatoes could be thrown away more than 40 percent of the harvest. And though Belgium's potato industry has urged patriots to take a high-calorie hit for the team by heading down to their local friteries twice a week to help reduce the spud surplus, it's increasingly clear that 11 million Belgians won't be able to handle the deep-fried mission alone. With restaurants and bars closed, and large summer events canceled, fries wont be as ubiquitous as they often are this summer. "Our entire sector is facing a big crisis. We don't just invite all Belgians to eat more fries, but the entire world," said Ward Claerbout from Agristo, a potato processing company in the west of Belgium.

Correction: Tuesdays edition of POLITICO Nightly incorrectly stated which tracks Iowa will open without spectators. The state will reopen certain race tracks without spectators but not horse and dog tracks. We regret the error.

A message from PhRMA:

In these unprecedented times, Americas biopharmaceutical companies are coming together to achieve one shared goal: beating COVID-19. The investments weve made have prepared us to act swiftly: Working with governments and insurers to ensure that when new treatments and vaccines are approved, they will be available and affordable for patients Coordinating with governments and diagnostic partners to increase COVID-19 testing capability and capacity Protecting the integrity of the pharmaceutical supply chain and keeping our plants open to maintain a steady supply of medicines for patientsExplore our efforts.

Did someone forward this email to you? Sign up here.

Read the original here:
Covid's war on women - Politico

Recommendation and review posted by Bethany Smith