The agreement includes development and commercialization of gepirone ER as well as development opportunities for follow-on products.
Subject to approval, gepirone ER will be the first-in-class 5HT1a agonist indicated for the treatment of major depressive disorder. Gepirone ER affects brain serotonin by binding to serotonin 5HT1a receptors.
Clinical study data suggest that gepirone ER treats depression with a low risk for sexual side effects that are known to occur with current therapies that work via serotonergic mechanisms. In clinical trials, dizziness, lightheadedness and nausea were the most frequently reported adverse events and occurred most often during early stages of treatment. Discontinuations due to these adverse events were less than 5%.
Under the terms of the agreement, Fabre-Kramer will receive an upfront cash payment followed by additional milestone payments. In addition, Fabre-Kramer will be entitled to receive commercial milestone payments and double-digit royalty payments on global sales of gepirone ER.
In return, GSK will be granted a license to develop, manufacture and commercialize gepirone ER and follow-on products.