Biscayne NeuroTherapeutics

Biscayne Neurotherapeutics was a clinical-stage biotechnology firm that focused on developing treatments for severe neurological disorders. The company was established in January 2017 as a spin-out from its parent, Biscayne Pharmaceuticals, to concentrate on biopharmaceutical assets for these conditions. It was co-founded by Samuel Reich, who served as Executive Chairman, and Dr. Steven Schachter, a Professor of Neurology at Harvard Medical School. Dr. Stephen Collins, a neurologist with extensive experience in developing anti-epilepsy drugs, was the President and CEO.

The company's primary focus was its lead compound, BIS-001 (later renamed SPN-817), a novel therapy for difficult-to-treat forms of epilepsy. This drug is a synthetic form of huperzine A, an acetylcholinesterase inhibitor derived from a traditional Chinese medicine. Its mechanism involves increasing levels of the neurotransmitter GABA in the brain, which helps to suppress seizures. The intellectual property for this technology was licensed from Harvard University, Yale University, and the University of South Florida. The company's business model revolved around advancing BIS-001 through clinical trials to eventually gain regulatory approval and commercialize it for patients with conditions like Dravet syndrome and other refractory epilepsies. In January 2017, the company secured $3 million in a Series B financing round to fund a Phase 1b clinical trial for an extended-release formulation of BIS-001. A significant milestone was achieved in May 2017 when the U.S. FDA granted Orphan Drug designation to BIS-001 for the treatment of Dravet syndrome, a severe form of childhood epilepsy.

In a strategic move to bolster its epilepsy franchise, Supernus Pharmaceuticals entered into a merger agreement to acquire Biscayne Neurotherapeutics in September 2018. The deal involved an upfront payment of $15 million, with potential future payments of $73 million tied to development milestones and up to $95 million based on sales milestones, bringing the total potential value to over $180 million. Following the acquisition, the lead compound BIS-001 was renamed SPN-817, and its development continued under Supernus, which gained worldwide rights excluding certain Asian markets. Dr. Collins was retained as a consultant to aid in the transition and future development of the drug.

Keywords: Biscayne Neurotherapeutics, Supernus Pharmaceuticals acquisition, epilepsy treatment, neurological disorders, BIS-001, SPN-817, Dravet syndrome, refractory epilepsy, clinical-stage biotechnology, huperzine A, acetylcholinesterase inhibitor, Stephen Collins, Samuel Reich, Steven Schachter, CNS disorders, Orphan Drug designation, anticonvulsant, partial seizures, neurology, biopharmaceutical