Healthcare Industry News: Mylan
News Release - November 18, 2016
Apricus Biosciences Provides Update on Vitaros NDA Following Receipt of FDA FeedbackSAN DIEGO, Nov. 18, 2016 -- (Healthcare Sales & Marketing Network) -- Apricus Biosciences, Inc. (APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that it has received feedback in response to its previously announced Type B Meeting request to the U.S. Food and Drug Administration (FDA). The purpose of the FDA meeting request was to confirm Apricus’ strategy for addressing the deficiencies contained in the 2008 Complete Response letter. Based upon our expert panel’s review of the FDA’s feedback, and the available Vitaros clinical and non-clinical data used to obtain regulatory approvals outside of the U.S., the Company believes that there is a viable regulatory pathway for resubmission of the Vitaros NDA in the U.S. and, as such, we intend to re-submit the NDA as soon as possible in 2017.
Specifically, the FDA provided clarity on the requirements needed to address the deficiencies in the 2008 Complete Response letter to include suggested additional analysis of existing clinical and non-clinical data. The FDA feedback did not indicate that new clinical studies would be required for re-submission. Importantly, the FDA determined that Vitaros, under current regulations, is now considered a drug-device combination and, as such, Apricus was advised to meet with the Office of Product Quality to confirm the necessary device engineering and compliance requirements for the NDA re-submission.
“We are encouraged by the FDA’s constructive feedback regarding the Vitaros NDA re-submission strategy and we appreciate their valuable input, which we believe will help to further strengthen our re-submission,” said Richard Pascoe, Chief Executive Officer of Apricus. “Importantly, we believe that we can adequately address the DDAIP safety and partner transference risk noted in the 2008 Complete Response letter and we can further strengthen our clinical benefit section in the planned re-submission, using a methodology provided to us by the FDA. However, given the determination by the FDA that Vitaros is now a drug-device combination, we will need to meet with the Office of Product Quality to clarify any additional conditions that may be required for approvability, which will likely delay our re-submission until the second half of 2017.”
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing innovative medicines in urology and rheumatology. Apricus’ commercial product, Vitaros®, for the treatment of erectile dysfunction, is approved in Canada and certain countries in Europe, Latin America and the Middle East and is being commercialized in several countries in Europe. In September 2015, Apricus in-licensed the U.S. development and commercialization rights for Vitaros from Allergan. Apricus’ marketing partners for Vitaros include Recordati Ireland Ltd. (Recordati), Ferring International Center S.A. (Ferring Pharmaceuticals), Laboratoires Majorelle, Bracco S.p.A., Mylan NV and Elis Pharmaceuticals Ltd. Apricus currently has one active product candidate, RayVa™, its product candidate for the treatment of the circulatory disorder Raynaud’s phenomenon.
For further information on Apricus, visit http://www.apricusbio.com.
*Vitaros® is a registered trademark of NexMed International Limited. Such trademark is registered in certain countries throughout the world and pending registration in the United States.
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: references to the need for additional clinical or pre-clinical data prior to the re-submission of the Vitaros NDA and the FDA’s view on such a need; the timing of the re-submission of the Vitaros NDA, including the need to address the issues raised by the FDA’s feedback or any issues raised by the Office of Product Quality related to the FDA’s determination that Vitaros is now a drug-device combination; and Apricus’ ability to address 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, including the Office of Product Quality, requiring additional clinical and pre-clinical data prior to the Vitaros NDA re-submission; Apricus’ ability to address any conditions for approvability raised by the FDA’s Office of Product Quality; 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 NDA re-submission and 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.
Source: Apricus Biosciences
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