Apricus Biosciences Announces Year-End 2015 Update and 2016 Growth Strategy
Top-Line Phase 2b Data for Fispemifene Expected in Q1
SAN DIEGO, Jan. 06, 2016 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today reviewed its 2015 corporate progress and highlights its plans for 2016.
- Initiated and completed enrollment in its fispemifene Phase 2b clinical trial for the treatment of symptomatic male secondary hypogonadism;
- According to IMS Midas, over 633,000 Vitaros units sold in Europe in 2015 through November;
- Vitaros® monthly sales in Europe tracked on a 111,000 monthly unit run rate, which is expected to grow in both existing markets and new markets with additional launches throughout 2016 by our commercialization partners;
- Completed and reported top-line data on the Phase 2a clinical trial of RayVa(TM) for Raynaud's phenomenon secondary to scleroderma;
- Licensed the U.S. development and commercialization rights for Vitaros from Allergan plc; and
- Expanded Vitaros partnerships to include parts of Asia, Eastern Europe and Latin America.
"2015 was a very productive year for Apricus as we achieved our primary goals of advancing our clinical pipeline and enhancing the commercial value of Vitaros," said Richard Pascoe, Chief Executive Officer. "Looking forward to the rest of the year, we expect a number of important clinical and commercial value drivers, including continued growth of Vitaros in Europe, Phase 2b fispemifene data in the first quarter, the re-submission of the Vitaros New Drug Application (NDA) in the second half of this year, and the advancement of our development pipeline."
Goals and Priorities for 2016
- Apricus will continue to leverage Vitaros as a cash-generating asset through royalty and milestone payments and by expanding the product's market reach via additional ex-U.S. launches by our commercialization partners;
- Apricus expects to obtain European approval for one or more variations to the approved Vitaros product with the goal of enhancing the profile of Vitaros;
- Apricus expects to re-submit the New Drug Application (NDA) for Vitaros' approval in the U.S. in the second half of 2016;
- Apricus plans to complete the Phase 2b clinical trial and report top-line data for fispemifene in symptomatic secondary hypogonadism in the first quarter 2016. Positive results from this trial, if achieved, would position Apricus to move fispemifene into additional late-stage clinical trials, when appropriate. Apricus will also continue development of fispemifene in Lower Urinary Tract Symptoms (LUTS) throughout 2016;
- Apricus expects to initiate a Phase 2b at-home dosing clinical trial with RayVa in the second half of 2016.
Mr. Pascoe concluded, "I would like to thank our employees and partners for their hard work and commitment to execution of key goals for 2015. I especially want to thank our investors for their patience and support as we look forward to commercial and clinical success in 2016 and beyond."
In addition, Apricus provided an update to its corporate presentation on the Company's website, www.apricusbio.com.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing innovative medicines in urology and rheumatology. Apricus recently completed enrollment in its Phase 2b trial for fispemifene, a selective estrogen receptor modulator for the treatment of symptomatic male secondary hypogonadism, and plans to conduct additional studies in other urological conditions. Apricus has completed a Phase 2a trial for RayVa(TM), its product candidate for the treatment of the circulatory disorder Raynaud's phenomenon, and plans to conduct additional clinical trials in patients with Raynaud's phenomenon secondary to scleroderma. Apricus' lead commercial product, Vitaros®, for the treatment of erectile dysfunction, is approved in Europe and Canada and is being commercialized in several countries in Europe. Apricus recently in-licensed the U.S. development and commercialization rights for Vitaros from Allergan. Apricus' marketing partners for Vitaros include Laboratoires Majorelle, Bracco S.p.A., Hexal AG (Sandoz), Takeda Pharmaceuticals International GmbH, Recordati Ireland Ltd. (Recordati S.p.A.), Ferring International Center S.A. (Ferring Pharmaceuticals) and Mylan NV. Apricus' second-generation room temperature Vitaros is currently under development.
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.
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 for key catalysts to drive value in 2016; Apricus' ability to continue to generate cash from licensing and milestone payments and royalty revenues from the sale of Vitaros® in various countries by Apricus' commercial partners; the development and potential resubmission of an NDA for U.S. Food and Drug Administration ("FDA") approval of Vitaros in the United States and expected timing thereof; the planned launch of Vitaros in additional countries and the growth of Vitaros' sales in existing markets; the potential European approval for one or more variations of Vitaros; the expected timing of top-line data for and the completion of the Phase 2b clinical trial for fispemifene in symptomatic secondary hypogonadism, and the potential of positive results to move fispemifene into additional late-stage clinical trials; the expected continued development for the second indication for fispemifene; the timing of the Phase 2b at-home dosing clinical trial of RayVa; and the timing and success of current and planned clinical trials. Actual results could differ from those projected in any forward-looking statements due to a variety of reasons that are outside the control of Apricus, including, but not limited to: the effect of the out-of-stock situation for Vitaros in Germany and the potential that Apricus' partner there, Sandoz, does not resume ordering product for Germany or other countries pending the results of an ongoing out-of-specification investigation by our contract manufacturer; Apricus' ability to have its product Vitaros approved by the FDA in the United States and by relevant regulatory authorities in Europe and in other countries; Apricus' ability to further develop Vitaros into new variations, such as the room temperature version of Vitaros, and its other product candidates, RayVa and fispemifene, as well as the timing of such events; Apricus' ability to successfully carry out and complete clinical studies for Vitaros, if required, RayVa and fispemifene, as well as the timing and success of such studies; feedback received from regulatory agencies, such as the FDA on the development of Apricus' product candidates; Apricus' dependence on its commercial partners to carry out the commercial launch or grow sales of Vitaros in various territories and the potential for delays in the timing of commercial launches in additional countries; competition in the erectile dysfunction market and other markets in which Apricus and its partners operate; Apricus' ability to obtain and maintain intellectual property protection for Vitaros, RayVa, fispemifene or any other product candidates; Apricus' ability to raise additional funding that it may need to continue to pursue its commercial and business development plans; Apricus' ability to remain in compliance with the terms and restrictions under its credit facility; Apricus' ability to access additional capital under its equity facility; Apricus' ability to obtain the requisite governmental approval for Vitaros, RayVa and fispemifene; and general market conditions. 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.
CONTACT: Institutional / Retail Investors:
The Trout Group