FDA Confirms Vitaros Regulatory Pathway
Company Seeking Partner to Develop Vitaros in U.S.
Company Evaluating Strategic Alternatives
SAN DIEGO, April 16, 2018 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced the outcome of its end-of-review meeting with the U.S. Food and Drug Administration (FDA) on the New Drug Application (NDA) for Vitaros(TM) (alprostadil, DDAIP.HCl), a topical cream for the treatment of erectile dysfunction.
The preliminary end-of-review meeting minutes support a plan to address issues cited by the FDA in its February 15, 2018 Complete Response Letter (CRL) for the Vitaros NDA. Specifically, the FDA confirmed during the meeting that the company should develop a new Vitaros formulation that reduces the concentration of DDAIP.HCl from 2.5% to 0.5% in order to address the tumor promotion and partner transference safety concerns noted in the CRL. The FDA also confirmed that two new Phase 3 clinical efficacy trials with the reformulated product should be conducted prior to resubmitting the NDA and that the trials should include an assessment of the potential risk of enhanced sexually transmitted infections with the new formulation. In addition, the FDA requested certain pharmacokinetic assessments that we expect can be completed as part of the requested Phase 3 program and any additional clinical or commercial safety data generated prior to a resubmission. Lastly, the FDA stated that the Chemistry, Manufacturing and Control (CMC) section in the resubmission will need to be updated with data generated during development of the new formulation.
The FDA previously issued a CRL for the Vitaros NDA, indicating that it could not approve the NDA for Vitaros in its present form, identifying deficiencies related to CMC and whether the modest treatment effect of Vitaros outweighed certain safety concerns specific to the 2.5% concentration of DDAIP.HCl contained in the current formulation.
"While we are pleased that the FDA has outlined a clear regulatory pathway for Vitaros, which we believe provides a path to approval in the U.S., the cost and timeline associated with a reformulation effort and completing additional phase 3 clinical trials exceeds our current resources and our ability to raise additional capital. Therefore, we have initiated discussions with interested parties for the U.S. Vitaros rights to enable its continued development and potential approval in exchange for financial terms commensurate with a development stage asset. In parallel, the Board of Directors has determined that Apricus should evaluate strategic alternatives or other business combinations, with the goal of maximizing shareholder value," said Richard Pascoe, Chief Executive Officer.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing innovative medicines in urology and rheumatology. Apricus has two product candidates: Vitaros, 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); and RayVa, a product candidate which has completed a Phase 2a clinical trial for the treatment of the circulatory disorder Raynaud's phenomenon, secondary to scleroderma, for which Apricus owns 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 potential to enter into a U.S. partnership regarding Vitaros; Apricus' ability to identify and conclude strategic transactions or other business combinations; and the timing of any clinical and non-clinical trials and studies to address the FDA's concerns and whether the results of such trials and studies would be sufficient to overcome the deficiencies raised in the CRL. 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: Apricus' financial position and need for additional capital to fund its operations, which may be adversely impacted if Apricus is unable to maintain the continued listing of its common stock on the Nasdaq stock market; a partnership with respect to U.S. Vitaros and any larger strategic transaction or other business combination may not be available on acceptable terms or at all; Apricus' ability to address any conditions for approvability of Vitaros raised by the FDA in the CRL; 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; 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.
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