SAN DIEGO, Oct. 13, 2014 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines to meet the needs of patients, today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application Serial Number 14/110,348 (the '348 application). The patent application generally is directed to methods and compositions for treating Raynaud's phenomenon, including claims related to treating Raynaud's phenomenon that is secondary to systemic sclerosis.
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, "The expected issuance of this patent further enhances the strategic and commercial value for the RayVa product as a first-in-class treatment for Raynaud's phenomenon, which we are pursuing initially as secondary to scleroderma. Given the chronic nature of this disease, the frequency of attacks that patients experience, no approved treatments, a clear regulatory pathway, and a low cost clinical development program, RayVa represents a significant advancement of our platform for the benefit of Raynaud's patients with an attractive return on investment for our shareholders."
A Notice of Allowance is issued after the USPTO makes a determination that a patent can be granted from an application upon payment of the issue fee. Apricus expects the patent to issue in the next few months. Once issued, the patent would be expected to expire no earlier than its twenty-year term in 2032. The Notice of Allowance and the allowed claims for the '348 application are posted on the USPTO public PAIR website.
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. The U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for RayVa, allowing the Company to initiate clinical testing. The Company expects to commence a Phase 2a clinical trial and begin enrollment in the second half of 2014.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing innovative medicines to meet the needs of patients. The Company's lead product, Vitaros®, for the treatment of erectile dysfunction, is approved in Europe and Canada and will be commercialized by Apricus' marketing partners, which 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. The Company's second-generation Vitaros room temperature device is under development and is expected to enhance the product's commercial value. The Company recently initiated a Phase 2a trial for RayVa™, the Company's product candidate for the treatment of Raynaud's phenomenon. Femprox®, the Company's product candidate for the treatment of female sexual interest/arousal disorder, has successfully completed an approximately 400-subject proof-of-concept study. The Company is currently seeking a strategic partner for Femprox.
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 commencement of a Phase 2a clinical trial 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.