Apricus Biosciences Provides Corporate Update And Third Quarter Financial Results

Strategic Focus on Growing Global Vitaros ® Revenue and Achieving Profitability in 2017 Apricus Granted Type B Meeting with FDA to Discuss the Vitaros ® U.S. NDA Re-Submission Conference Call / Webcast Today, Tuesday, November 8, 2016 at 4:30 p.m. ET

SAN DIEGO, Nov. 08, 2016 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today reported financial results for the third quarter of 2016 and provided a corporate update on its priorities for 2016.

"In the third quarter, we focused our efforts on advancing the regulatory and commercial success of Vitaros ® through our partners.  Since July, our partners have launched Vitaros in five additional countries in Europe, and received an additional five marketing authorizations for Vitaros in Europe, Latin America and the Middle East.  Further, the transfer of commercial rights to Ferring in certain countries in Europe and Asia was completed," stated Richard W. Pascoe, Chief Executive Officer.  "Looking forward, our focus continues to be increasing Vitaros ex-U.S. revenue and obtaining the regulatory approval of Vitaros in the United States.  Our Type B meeting with the FDA, which is scheduled for November 17, 2016, remains on schedule.  The purpose of this meeting is to confirm our strategy for addressing the deficiencies contained in the original 2008 Complete Response letter. We will incorporate any FDA feedback into the final resubmission, which we expect to occur in the fourth quarter."

Third Quarter Highlights and Recent Developments

Apricus continued to focus its corporate goals on increasing Vitaros' value through the fostering and expansion of its commercial partnerships, in the U.S. and globally, and strengthening the Company's financial position.  Third quarter and recent highlights include:
  • Announced receipt of regulatory approval of Vitaros in Lebanon by the Company's partner in the Middle East, Elis Pharmaceuticals, marking an important entry into a highly attractive Middle Eastern erectile dysfunction market;
  • Obtained regulatory approval in Europe for an improved delivery device material of construction for the refrigerated version of Vitaros;
  • Completed the transfer of the Vitaros marketing authorizations in Germany, the United Kingdom, Finland and Denmark to Ferring Pharmaceuticals (Ferring);
  • Announced launch of Vitaros in Portugal, Ireland, Poland, Czech Republic and Slovakia by the Company's partner, Recordati Ireland Ltd. (Recordati);
  • Announced receipt of regulatory approval of Vitaros in Argentina by Ferring, marking the first country in Latin America to do so; and
  • Closed two separate offerings of common stock and warrants with institutional investors for gross proceeds of approximately $4.9 million.

Strategic Priorities

Apricus continues to focus on achieving the following key strategic objectives:

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