Apricus Biosciences Issues Update On Vitaros NDA Resubmission - Quick Facts

(RTTNews) - Apricus Biosciences, Inc. (APRI) announced the U.S. FDA has acknowledged receipt of its recently resubmitted New Drug Application for Vitaros (alprostadil) and considers it a complete, class 2 response to Apricus' 2008 action letter. The PDUFA goal date for completion of the FDA's review of the Vitaros NDA is set for February 17, 2018.

Apricus in-licensed the U.S. development and commercialization rights for Vitaros from Allergan pursuant to a license agreement in 2015. Pursuant to the license agreement, upon FDA approval of the NDA for Vitaros, Allergan may elect to exercise a one-time opt-in right to assume all future marketing and selling activities in the U.S. If Allergan exercises its opt-in right, Apricus may receive up to a total of $25 million in upfront and potential launch milestone payments, plus a double-digit royalty on net sales of Vitaros. If Allergan elects not to exercise its opt-in right, Apricus may commercialize Vitaros and in return will pay Allergan a double-digit royalty on net sales of Vitaros.