SAN DIEGO, Jan. 27, 2015 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, announced that today, January 27, 2015, the United States Patent and Trademark Office (USPTO) issued to Apricus, U.S. Patent No. 8,940,794, titled "METHODS AND COMPOSITIONS FOR TREATING RAYNAUD'S DISEASE," with claims generally directed to methods for treating Raynaud's phenomenon, that is secondary to systemic sclerosis. The patent is expected to expire no earlier than its twenty-year term in 2032.
RayVa™ is the proprietary name for Apricus' product candidate for the treatment of Raynaud's phenomenon. Raynaud's phenomenon is a circulatory disorder affecting the hands and feet. Raynaud's phenomenon secondary to systemic sclerosis affects an estimated three to five percent of people in the U.S., disproportionately affecting women and currently has no approved therapy in the U.S., representing an unmet medical need. The FDA has indicated that Apricus' RayVa product may qualify for priority review, given the unmet medical need and lack of approved products to treat secondary Raynaud's phenomenon. The FDA will determine if the RayVa New Drug Application qualifies for priority review following its submission, which could occur as early as 2017.
Richard Pascoe, Chief Executive Officer of Apricus, commented, "We are excited about the issuance of this patent as it further increases the value for the RayVa product as a first-in-class treatment for Raynaud's phenomenon, which we are pursuing initially as secondary to scleroderma. We look forward to establishing proof-of-concept for RayVa in the first half of this year with the goal of advancing the RayVa clinical development program in this difficult-to-treat patient population for which there is no adequate or approved therapies in the United States."
About RayVa™
RayVa is the proprietary name for Apricus' product candidate for the treatment of Raynaud's phenomenon. The RayVa product combines alprostadil, a vasodilator, with Apricus' proprietary permeation enhancer, and is applied as an on-demand topical cream to affected extremities. Patient enrollment commenced in December 2014 for a 45-patient Phase 2a clinical trial for RayVa. Apricus believes RayVa's market potential could approach $200 million in annual sales, as it would be the only FDA approved treatment for this debilitating condition.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing innovative medicines in urology and rheumatology. Apricus' lead product, Vitaros®, for the treatment of erectile dysfunction, is approved in Europe and Canada and is being commercialized in several countries in Europe. Apricus' marketing partners for Vitaros include Abbott Laboratories Limited, Takeda Pharmaceuticals International GmbH, Hexal AG (Sandoz), Recordati Ireland Ltd. (Recordati S.p.A.), Bracco S.p.A. and Laboratoires Majorelle. Apricus' second-generation Vitaros Room Temperature Device is under development and is expected to enhance the product's commercial value. Apricus recently commenced a Phase 2a trial for RayVa, its product candidate for the treatment of the circulatory disorder Raynaud's phenomenon. Additionally, Apricus plans to initiate a Phase 2b trial for fispemifene, a selective estrogen receptor modulator for the treatment of male secondary hypogonadism, chronic prostatitis and lower urinary tract symptoms. Apricus is currently seeking a strategic partner to fund development of Femprox®, a product candidate for the treatment of female sexual interest/arousal disorder that completed an approximately 400-subject proof-of-concept study.
For further information on Apricus, visit http://www.apricusbio.com.
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: references to the timing of the establishment of proof of concept and the submission of a New Drug Application for RayVa™, the size of the commercial opportunity for RayVa and the ability to build a focused commercial organization for RayVa. Actual results could differ from those projected in any forward-looking statements due to a variety of reasons that are outside the control of the Company, including, but not limited to: its ability to further develop its product candidate RayVa for the treatment of Raynaud's phenomenon, as well as the timing of such events; Apricus' ability to carry out clinical studies for RayVa, as well as the timing and success of the results of such studies; Apricus' ability to raise additional funding that it may need to continue to pursue its commercial and business development plans; Apricus' ability to obtain the requisite governmental approvals for RayVa; and 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 the Company's 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 the Company