GSK and Fabre-Kramer to develop gepirone

UK drug major GlaxoSmithKline and US psychotropic drug developer Fabre-Kramer Pharmaceuticals have established a worldwide agreement to commercialize the extended-release formulation of latter's major depressive disorder treatment, gepirone. The deal includes options to develop a series of follow-on products.

Subject to approval by the US Food and Drug Administration and other regulatory agencies around the world, the drug, which is a 5HT1a agonist that mediates its effect by binding to serotonin receptors in the brain, will be the first of its type to be licensed for use in MDD. Clinical study data has indicated that the compound is an effective treatment for depression and has a low risk of the sexual dysfunction side effects that are known to occur with current therapies that interact with seratogenic pathways.

Under the terms of the accord, FKP will receive an upfront fee followed by additional milestone payments based on certain regulatory and commercialization milestones. The US firm is also entitled to double-digit royalties based on worldwide sales of the product. In return, GSK will gain an exclusive license to develop, manufacture and sell the drug, and a similar option for related agents, around the world. Financial terms of the agreement were not disclosed.