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A partner for the global stage
SAN DIEGO—In hopes of advancing Femprox, a topical alprostadil cream for the treatment of female sexual interest/arousal disorder (FSIAD), Apricus Biosciences Inc. has announced its intention to secure a global development partner. Apricus, a biopharmaceutical company developing innovative medicines in the fields of urology and rheumatology, has completed nine clinical studies for the drug to date, including a proof-of-concept trial consisting of nearly 400 subjects that achieved statistical significance in both its primary and secondary endpoints. The company is now looking to take Femprox to the global market.
“Given the recent FDA approval of Sprout Pharmaceuticals Inc.’s flibanserin for female sexual dysfunction, Apricus now believes that a potential regulatory path exists in the U.S. for Femprox,” Richard Pascoe, CEO of Apricus, commented in a press release. “We will immediately initiate a disciplined partnering process to identify potential licensees for the global development and commercialization rights for Femprox with the goal of maximizing our return on investment for the potential benefit of shareholders.”
Femprox is a 0.4 percent alprostadil cream meant to treat FSIAD. The drug releases a local, relaxant effect on vulvar and clitoral blood vessels, which leads to increased blood flow that is in turn expected to increase lubrication and sensory feedback to boost sexual arousal in women. Femprox is delivered using Dodecyl 2-(N, N dimethylamino)-propionate, Apricus’ drug delivery technology. This technology is described as “a novel proprietary skin permeation enhancer” that functions by loosening the tight junctions of skin cells.
In 2012, Apricus shared data from its Phase 3, randomized, double-blind study of Femprox at the 2012 World Meeting on Sexual Medicine, with Dr. Irwin Goldstein, director of sexual medicine at the Alvarado Hospital in San Diego and a member of Apricus’ Femprox clinical advisory board, presenting the data. Slides from the presentation relayed that the study consisted of women with FSIAD ages 22 to 65, with a primary efficacy endpoint of satisfactory sexual events and secondary efficacy endpoint of the Female Sexual Function Index, Female Sexual Distress Score and global assessment question. At a dose of 900 mcg, Femprox demonstrated clinically significant improvement over placebo in all primary and secondary endpoints.
Apricus’ other pipeline products include fispemifene, a Phase 2 selective estrogen receptor modulator for the treatment of symptomatic male secondary hypogonadism, and RayVa, a Phase 2 product candidate for the treatment of Raynaud’s disease. Raynaud’s is a circulatory disorder that affects the blood vessels, causing some areas of the body, such as the hands or feet, to feel numb or cold and sometimes turn white in response to cold temperatures or stress. Apricus has begun a Phase 2b trial for fispemifene, with additional studies planned in other urological conditions, and enrollment was recently completed for a Phase 2a trial of RayVa.
On the commercial side, Apricus’ lead product is Vitaros, an erectile dysfunction treatment approved in Canada and Europe. The company recently announced a license agreement in which it secured the U.S. development and commercialization rights for Vitaros from Allergan. Warner Chilcott, which is now a subsidiary of Allergan, acquired the U.S. rights to Vitaros in February 2009. Under the terms of this agreement, Apricus will assume responsibility for all Vitaros development efforts in the United States, and should the U.S. Food and Drug Administration accept an NDA for Vitaros, Allergan can choose to exercise its one-time opt-in right to assume all future marketing and selling activities in the United States in exchange for certain financial considerations. Should Allergan exercise that right, Apricus stands to receive up to a total of $25 million in upfront and potential launch milestone payments, as well as a double-digit royalty on net sales of Vitaros. If Allergan doesn’t exercise its option, Apricus can commercialize Vitaros and will pay Allergan a double-digit royalty on net sales of the product. The agreement stipulates that in return for the development and commercialization rights, Apricus paid Allergan $1 million up front, with Allergan eligible to also receive a future $1.5-million regulatory milestone payment. Allergan also retains the right to launch a future authorized generic under a profit-share structure with Apricus.