Apricus Biosciences, Inc.
Apricus Biosciences Files NDA Resubmission for Vitaros(TM)
Approval Decision Expected in First Quarter 2018
SAN DIEGO, Aug. 29, 2017 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today reported that it recently filed its resubmission of a New Drug Application ("NDA") for Vitaros(TM) (alprostadil, DDAIP.HCl) with the U.S. Food and Drug Administration ("FDA"). Apricus anticipates a six-month review by the FDA with a projected PDUFA (Prescription Drug User Fee Act) goal date in the first quarter of 2018, which it expects the FDA to acknowledge within 30 days of the NDA filing date.
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 pleased to announce that we have filed the U.S. Vitaros NDA resubmission with the FDA," stated Richard W. Pascoe, Chief Executive Officer. "We have received electronic confirmation of the FDA's receipt of our filing and we anticipate an approval decision in the first quarter of 2018. Importantly, we believe we have completely addressed the deficiencies noted in the complete response letter and strengthened the overall Vitaros risk-reward profile with the goal of bringing an innovative erectile dysfunction treatment to patients whose needs are not met by currently approved therapies."
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(TM) 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(TM) 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 PDUFA goal date to be set by the FDA; and whether Apricus completely addressed the clinical and non-clinical data deficiencies and other deficiencies noted in the 2008 Complete Response letter. 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 may not accept the filing of the Vitaros NDA resubmission; the FDA could require additional clinical and pre-clinical data; Apricus' ability to have addressed any conditions for approvability raised by the FDA; 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; 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.
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