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.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing innovative medicines in urology and rheumatology. Apricus has two product candidates currently in development. Vitaros is a product candidate in the United States for the treatment of erectile dysfunction, which is in-licensed from Warner Chilcott Company, Inc., now a subsidiary of Allergan plc (Allergan). RayVa is our product candidate in Phase 2 development for the treatment of the circulatory disorder Raynaud’s phenomenon, secondary to scleroderma, for which we own worldwide rights.
For further information on Apricus, visit http://www.apricusbio.com.
Vitaros™ is Apricus’ trademark in the United States, which is pending registration and subject to the agreement with Allergan. Vitaros® is a registered trademark of Ferring International Center S.A. in certain countries outside of the United States. RayVa™ is Apricus’ trademark, which is registered in certain countries throughout the world and pending registration in the United States.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act, as amended. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things: the timing of the FDA’s review of the re-submission of the Vitaros NDA; the potential approval of the NDA by the FDA; and Vitaros addressing a significant unmet need in the ED market. Actual results could differ from those projected in any forward-looking statements due to a variety of reasons that are outside of Apricus’ control, including, but not limited to: the FDA could require additional clinical and pre-clinical data; Apricus’ ability to have addressed any conditions for approvability raised by the FDA in the 2008 action letter or the FDA identifying other deficiencies in the resubmission; risks related to the possibility of an advisory committee meeting related to Vitaros; the risks of any additional adverse safety or other data arising from the sales and use of Vitaros in certain countries in Europe and elsewhere; Apricus’ financial position and need for additional capital to fund its operations through the FDA’s review of the NDA, which may be adversely impacted if Apricus is unable to maintain the continued listing of its common stock on the Nasdaq stock market; competition in the ED market; and other risks identified by Apricus in its reports filed with the Securities and Exchange Commission (SEC). These forward-looking statements are made as of the date of this press release, and Apricus assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Readers are urged to read the risk factors set forth in Apricus’ most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q, and other filings made with the SEC. Copies of these reports are available from the SEC's website at www.sec.gov or without charge from Apricus.
The Trout Group