Last October, Apricus Biosciences, Inc., a biopharmaceutical company advancing innovative medicines in urology and rheumatology, announced that The United States Patent and Trademark Office (USPTO) had issued a Notice of Allowance for U.S. Patent Application to RayVa, a product candidate being developed by Apricus Biosciences for the treatment of Raynaud’s phenomenon (RP), including the treatment of the condition secondary to Scleroderma. On January 27, the company announced that their patent was awarded — news that anxiously awaiting shareholders and SSc patients with Raynaud’s phenomenon were elated to hear.
The patent, entitled “Methods and Compositions for Treating Raynaud’s Disease,” is expected to expire no earlier than its twenty-year term in 2032.
In a statement highlighting the importance of this announcement, Richard Pascoe, Chief Executive Officer of Apricus, said, “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 RP, 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.”
RP is a condition that is characterized as a loss of blood flow (vasoconstriction) to the extremities. The patients will most often times notice their fingers and/or toes becoming white or blue when they are cold, leading to a tingling and numbing sensation, and in severe cases a complete loss of feeling. This condition affects women more often than men (5 to 1). When the condition occurs without any underlying cause it is known as primary RP, otherwise when it is accompanied by another medical condition it is referred to as secondary RP. For the 100,000 patients who are diagnosed with scleroderma in the US, secondary RP is a condition that 90% struggle with. The patent approval is an optimistic sign that this population of patients and their healthcare providers may have a successful treatment option to look forward to in the near future.
Apricus Biosciences, Inc., was incorporated on October 20, 1987 but did not enter the competitive pharmaceutical market until 1995. The company is focused on research and development using their technology, NexACT that enhances the topical or oral delivery of an active drug to the patient. The company’s current list of NexACT therapeutics that are approved or in the late-stages of the approval process includes: Vitaros, which is approved in Canada for the treatment of erectile dysfunction, Femprox for female sexual arousal disorder, MycoVa for fungal infections of the nails, RayVa for Raynaud’s Syndrome and PrevOnco for liver cancer.
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.