Market Overview

BLS Pharma Alleges Inovio's Breach of Contract Obstructed Ability to Deliver Testosterone Replacement Therapy for Hypogonadism and the Transgender Community

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BLS Pharma, Inc. filed a complaint late last month against Genetronics, Inc. and Inovio Pharmaceuticals, Inc. (NASDAQ:INO), Case No. 30-2019-01119045, for breaching a contract to supply a needle-free injection system that BLS Pharma was using to develop a drug-device combination (DDC) for testosterone replacement therapy.

Testosterone replacement therapy is a multi-billion-dollar market primarily used to treat male hypogonadism, a condition in which the body fails to produce enough testosterone. It is also a necessary treatment for transgender individuals transitioning and on lifetime hormone therapy from female to male.

"Testosterone replacement therapy can make a significant difference for those in need of treatment. Our product would have allowed users to administer their treatments from the comfort of their own homes using a virtually painless needle-free system," said Mark Logomasini, President & CEO of BLS Pharma.

The shareholders of BLS Pharma previously developed the needleless injector technology, called "Zetajet," and sold the intellectual property rights for it to Inovio and Genetronics, with the condition that Genetronics would execute a license and supply agreement to supply Zetajet units to BLS Pharma upon request. Under the agreement, BLS Pharma ordered 25,000 Zetajet units to prepare for its clinical trials on the DDC and was assured that the order was "in process."

In September, BLS Pharma and Genetronics discussed the logistics of the syringe supply, and BLS Pharma's plan to offer the product for patients with hypogonadism and as a treatment for transgender males. The next business day, Inovio and Genetronics informed BLS Pharma they would not be supplying the syringes. This breach of contract eliminated BLS Pharma's ability to bring the DDC to market.

"We are disappointed that we cannot offer this solution for male hypogonadism and to the transgender community, who have historically been marginalized by the medical and pharmaceutical community," stated Logomasini.

The testosterone treatment market is valued at 1.3 to 1.8 billion dollars annually. BLS Pharma's lost profits due to the breach of contract are estimated to be at least $72,900,000. All media inquiries should be directed to Jason Hartley of the Hartley LLP law firm at (619) 400-5822. For a copy of the complaint, email karen@fullkorrpress.com.

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