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news.Apricus Biosciences, a biopharmaceutical company advancing innovative medicines in urology and rheumatology, announced that, 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.
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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."
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.