Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) announced that it has entered into an agreement with ALZA Corporation and Janssen Pharmaceutica, N.V. whereby ALZA and Janssen will transfer worldwide rights for Priligy® to Furiex. Currently Priligy is marketed by Janssen for on-demand treatment of premature ejaculation in 15 countries in Europe, Asia and Latin America, while it is approved for that indication in 43 countries worldwide.
To ensure a smooth transition, Janssen will continue to manufacture and manage certain clinical and regulatory activities with respect to Priligy for a pre-defined period after the closing date of the agreement. Janssen will continue to make Priligy available to patients until the Marketing Authorizations are transferred, at which time commercialization of the product will transition to Furiex or its licensee.
“Priligy is the only treatment for premature ejaculation that has received regulatory approval, and we appreciate Janssen’s commitment for a smooth transition so that patients can continue to receive this important medicine,” said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex.
Under the agreement, Janssen will transfer to Furiex registration and commercialization activities for Priligy worldwide. Janssen will remain the Marketing Authorization Holder for Priligy until Marketing Authorization is transferred to Furiex or its licensee in each country.The asset transfer is subject to various closing conditions, including negotiation and execution of additional agreements, and is expected to close in the third quarter of 2012. About Premature Ejaculation Premature ejaculation (PE) is a distressing sexual dysfunction that can be present from the first sexual encounter or can develop later in life. It is the most common male sexual dysfunction, affecting about 30 percent of male adult population at some point during their lives. The condition consists of three major components: a short time to ejaculation; lack of ejaculatory control; and negative personal impact, including distress related to rapid ejaculation. A combination of physiological and psychological factors is believed to influence the mechanism of ejaculation. Research suggests serotonin plays a central role in the timing of ejaculation.