Supernus Pharmaceuticals acquires Biscayne Neurotherapeutics and with it SPN 817 a new drug for epilepsy.

Supernus Pharmaceuticals, Inc. a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced that it entered into a merger agreement to acquire Biscayne Neurotherapeutics (Biscayne), a privately-held company developing a novel treatment for epilepsy. Supernus will obtain worldwide rights (excluding certain markets in Asia where rights have been out-licensed) to Biscayne�s product candidate that is in Phase I clinical development and that has received an Orphan Drug designation from the FDA for the treatment of Dravet Syndrome, a severe form of childhood epilepsy. Supernus will also obtain rights to all the product candidate�s underlying and related intellectual property (IP). The transaction, expected to close in the next few weeks, provides for an upfront payment of $15 million payable by Supernus to the current Biscayne security holders. Additional payments payable by Supernus include $73 million contingent on achieving certain development milestones and up to $95 million contingent upon achieving certain sales milestones. Supernus will pay a low single digit royalty on net sales to Biscayne and any applicable royalties to third parties for the use of in-licensed IP. The maximum combined royalty Supernus will pay to all parties is approximately 12%, depending on the IP covering the marketed product and the applicable tiered sales levels. The development program which will be referred to as SPN-817 will utilize a novel synthetic form of huperzine A which is a potent acetyl cholinesterase inhibitor with pharmacological activities in CNS conditions such as epilepsy. SPN-817 will have a new chemical entity status (NCE) in the U.S. market, and Supernus expects to have significant IP protecting this product candidate through its own research and development efforts as well as the in-licensed IP. SPN-817 represents a novel mechanism of action for an anticonvulsant. Development of SPN-817 will initially focus on the drug�s anticonvulsant activity that has been shown in preclinical models for partial seizures and Dravet Syndrome. It increases cortical acetylcholine and readily crosses the blood brain barrier showing an increase in gamma-aminobutyric acid (GABA), a seizure inhibitor, in the cortical region of the brain. In a predictive preclinical seizure model, huperzine A demonstrated 57 times more potency than levetiracetam, a leading anti-epilepsy drug.