Apricus Biosciences Announces FDA Acknowledgement of Vitaros™ Class 2 NDA Resubmission
PDUFA Goal Date of February 17, 2018
SAN DIEGO, Aug. 31, 2017 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that the U.S. Food and Drug Administration (“FDA”) has acknowledged receipt of its recently resubmitted New Drug Application (“NDA”) for Vitaros™ (alprostadil, DDAIP.HCl) and considers it a complete, class 2 response to Apricus’ 2008 action letter. The PDUFA (Prescription Drug User Fee Act) goal date for completion of the FDA’s review of the Vitaros NDA is set for February 17, 2018, which is the standard six month review period for NDA resubmissions.
Vitaros is a novel, on-demand topical cream for the treatment of erectile dysfunction (“ED”) and a new potential entrant into the U.S. ED treatment market. Vitaros has been approved in Canada, Mexico, and certain countries in Europe, Latin America and the Middle East, and the product is being commercialized by Ferring International Center S.A. and its licensees throughout Europe and in the Middle East.
“We are very pleased to announce that the FDA has acknowledged receipt of our U.S. Vitaros NDA resubmission and our PDUFA goal date is February 17, 2018,” stated Richard W. Pascoe, Chief Executive Officer. “The FDA has determined that the resubmission is a complete, class 2 response to our 2008 action letter. Importantly, we believe that Vitaros, if approved, will address a significant unmet need in the erectile dysfunction market.”
Apricus in-licensed the U.S. development and commercialization rights for Vitaros from Allergan pursuant to a license agreement entered into between the parties in September 2015. The U.S. Vitaros asset was previously purchased by Warner Chilcott, now a subsidiary of Allergan, from Apricus back in February 2009. Pursuant to the terms of 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 United States. 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.
