Inovio Pharmaceuticals breached a contract to supply needle-free injectors after learning they would be used to inject testosterone by transgender men, according to a lawsuit filed Nov. 1 in San Diego Superior Court.

BLS Pharma says Inovio was cooperative until it learned the biomedical companys ZetaJet injectors would be used by the transgender men, instead of just men with insufficient testosterone, a condition called male hypogonadism. BLS asked Inovio for its reasons, and the company failed to give a valid reply, according to the lawsuit.

Inovio rejects the claim. The lawsuit has absolutely no merit, said Jeff Richardson, an Inovio spokesman.

San Diego is where Inovio performs research, development, engineering and manufacturing. Company headquarters is in Plymouth Meeting, Pennsylvania. BLS Pharma is headquartered in Lake Forest, Calif.

The civil lawsuit says the monetary loss totals $72.9 million under a conservative estimate. Besides breach of contract, the lawsuit also alleges fraud and negligent misrepresentation.

Inovio acquired ZetaJet in 2016 when it paid $4.3 million in stock and $1.2 million cash for BioJect, its maker. The device uses high pressure supplied by a spring to force liquid medicine through the skin.

The lawsuit says that sale included a provision to sell ZetaJets to the sellers upon request, negotiating in good faith to supply the devices at a 15 percent premium to production cost.

The sellers formed BLS to continue work already planned to enter the needle-free injection market, including testosterone, the lawsuit said. The combination of device and needle-free testosterone syringe would allow patients to inject themselves with greater ease and comfort than by using a needle.

Both men with hypogonadism and biological women becoming transgender men require continual testosterone supplementation to maintain normal male levels of the hormone. That market is valued at $1.3 and $1.8 billion annually, the lawsuit said.

In early 2017, BLS told Inovio it planned to buy the ZetaJets under the contract, for use in a planned clinical trial. It asked for 25,000 of them in April, and negotiations proceeded over the summer while BLS discussed its plans with the FDA, which regulates clinical trials.

On Sept. 7, BLS told Inovio that it had received favorable news about testing the system for transgender men in addition to men with insufficient testosterone.

The following Monday, September 11, 2017, Defendants requested a call with Plaintiff, the lawsuit stated.

At that time Defendants advised Plaintiff that they were rejecting the syringe order, would not authorize BLS to take over manufacturing of the syringes, that their legal department would be sending a letter terminating the relationship, and that they would return the check previously issued by BLS for payment.

According to the lawsuit, Inovio gave as its reason, We dont need transgender, we have Gates.

BLS said it interpreted that reply as meaning that Inovio was already supporting a different publicizable public interest effort through a separate project with the Gates Foundation.

In the following months, BLS said, it tried and failed to find an alternative supplier of the injectors, leaving it without any way to test its product.

The lawsuit also names as defendant Genetronics, a San Diego-based Inovio predecessor. Genetronics purchased Norway-based Inovio in 2005, and shortly thereafter changed the combined companys name to Inovio. The lawsuit says Genetronics is now an Inovio subsidiary.

A civil case management conference has been set for June 19, 2020, according to a Superior Court filing for the case. The case number is 37-2019-00058344-CU-BC-CTL.

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Lawsuit claims contract breached over transgender testosterone therapy - The San Diego Union-Tribune

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