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Good morning! A crowdsourced Readout today, to be sure, with contributions from STATs Jason Mast, Elaine Chen, and Jonathan Wosen. We get into earnings from Novo Nordisk, Amgen, and Illumina, and see that ICER is not so enthused about a gene therapy from Sarepta.

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Novo Nordisk CEO Lars Fruergaard Jrgensen is standing by the cost of Ozempic and Wegovy, despite an ongoing Senate investigation into the companys pricing. In an earnings call yesterday, he said the drugs offer an attractive value proposition as theyre priced similarly to earlier, less effective iterations of this class of drugs.

Although he conceded that the number of people taking the drugs is to some degree putting strains on health care systems, STATs Elaine Chen writes, the full value of these diabetes and obesity drugs has yet to be realized. Ozempics list price is $969 monthly; Wegovys is $1,349. Executives on the call said that the net prices for these drugs have already come down, and will continue to do so as more people take it and as competition increases.

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The removal of small amounts of brain tissue from desperately ill patients, done as part of a Mount Sinai research project, triggered alarm bells at the FDA and has raised broader questions about the scientific and ethical justification for live-brain research. Journalist and STAT contributor Katherine Eban joins The Readout LOUD this week to discuss the findings of atwo-year investigation.

Also on this weeks episode, STATs Adam Feuerstein and Allison DeAngelis discuss Novartis effort to acquire MorphoSys, and the latest news on Eli Lilly and Novo Nordisks blockbuster obesity drugs with Elaine Chen.

Listen here.

From STATs Jason Mast:The drug-pricing watchdogs over at the Institute for Clinical and Economic Review, or ICER, often take a dim view of modern drug pricing exceptwhen it comes to genetherapy. Those treatments, the nonprofit has said, often provide the years-long benefits for severe disease that justify a multimillion-dollar price tag.

Which makes theJAMApiecepublishedthis week by ICER CMO David Rind all the more notable. Rind considered Elevidys, Sareptas $3.2 million gene therapy for Duchenne muscular dystrophy. The treatment was given accelerated approval last year for 4- and 5-year-olds and, after a Phase 3 trial, the FDA is now considering whether to approve it for all ages.

That Phase 3 trial missed its primary endpoint, though, as did a previous smaller study. Sarepta has pointed to the results on secondary measures but given those data, Rind cast doubt on whether it should be approved and certainly whether Sarepta should charge what other gene therapy companies do. This is an enormous price tag for a therapy that has failed to meet its primary end point in the 2 randomized trials in which it has been studied and that is clearly not curative, he wrote.

From STATs Jonathan Wosen:DNA sequencing juggernaut Illumina reported yesterday $1.06 billion in revenue for its core business during the first quarter of this year, down 2% from the same time last year, with the companys execs reiterating that they expect 2024 revenue to essentially match the $4.5 billion from the previous fiscal year.

CEO Jacob Thaysen cautiously described the first-quarter numbers as a decent start to the year that exceeded expectations on a call with market analysts and investors. The updated numbers come during a turbulent time for the broader sequencing space. Pacific Biosciences, a Bay Area company that Illumina once unsuccessfully tried to acquire, recently laid off nearly 200 employees after reporting disappointing first-quarter sales. And while Illumina continues to control about 80% of the market, its shares are down 37% from a year ago and the firm faces growing competition from players such asUltima, Singular Genomics, andElement Biosciences.

The San Diego genomics giant is still on track to finalize the terms of its divestiture of Grail a cancer detection startup Illumina had acquired for $8 billion, drawing the ire of regulators in the U.S. and Europe by the end of the second quarter of this year.

From STATs Elaine Chen:Amgen will scrap an early-stage obesity pill, and will instead focus on its more advanced injectable candidate called MariTide thats seen as a potential competitor to Wegovy and Zepbound.

MariTide is in a Phase 2 trial for obesity, and CEO Bob Bradway said on the earnings call yesterday that we are very encouraged with the results from an interim analysis of that trial. The company is planning a broad Phase 3 program that will study MariTide in obesity, diabetes, and obesity-related conditions, and its already gearing up to make large amounts of the drug, initiating activities to further expand manufacturing capacity with both clinical and commercial supply in mind, Bradway said.

MariTide has an interesting mechanism its a monoclonal antibody linked to two peptides that activates receptors of the GLP-1 hormone while blocking receptors of the GIP hormone. Even though that appears to contradictory to the mechanism of Lillys potent obesity drug Zepbound, which activates both GLP-1 and GIP receptors, MariTide has shown potential to induce potent and longer-lasting weight loss.

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See the rest here:
Readout Newsletter: Amgen, Illumina, Novo Nordisk, and more - STAT

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