SAN DIEGO—Apricus Biosciences, Inc., a biopharmaceutical company advancing innovative medicines in urology and rheumatology, has licensed the U.S. development and commercialization rights for Vitaros from Allergan. Under the license agreement, Apricus will be responsible for all Vitaros development efforts in the United States. Upon the Food and Drug Administration's (FDA) acceptance of a New Drug Application (NDA) for Vitaros, Allergan may elect 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.
Vitaros is a novel, on-demand topical cream for the treatment of erectile dysfunction (ED) and a new potential entrant into the U.S. ED-treatment market. In February 2009, Warner Chilcott, now a subsidiary of Allergan, acquired the U.S. rights to Vitaros from Apricus. Since that time, Vitaros has been approved by the European health authorities and by Health Canada and is currently being promoted by Apricus' licensees throughout Europe.
Richard Pascoe, CEO of Apricus, commented, "We are pleased to announce this transaction for the return of the U.S. Vitaros rights to Apricus and we look forward to working with Allergan to transition the regulatory submission back within our organization. This agreement creates a framework where both parties can leverage their respective strengths with the goal of bringing this novel topical treatment to the world's largest ED market, which had sales of over $3 billion in 2014 according to IMS Health. Moreover, we believe that with Apricus' broad Vitaros expertise and internal knowhow, coupled with our proven success in obtaining regulatory approvals for Vitaros in other territories, we are well equipped to pursue regulatory approval for Vitaros in the U.S."
Pascoe discussed the transaction during his presentation at the Rodman & Renshaw 17th Annual Global Investment Conference on Thursday, September 10, 2015. He detailed for the conference and in a live audio webcast of the presentation Apricus’ near-term plans for growth. He outlined progress with “three compelling drugs”—Vitaros, fispemifene, a selective estrogen receptor modulator for the treatment of symptomatic male secondary hypogonadism, with plans to conduct additional studies in other urological conditions; and RayVA, its product candidate for the treatment of the circulatory disorder Raynaud's phenomenon for which Apricus recently completed enrollment in a Phase 2a trial.
Returning to the discussion of Vitaros, Pascoe pointed out to the conference that by virtue of its topical application, the drug bypasses organ systems that can be affected by oral ED treatments. He suggests that up to 49 percent of individuals who suffer from ED currently go untreated due to side effects.
Under the terms of the agreement, Allergan granted Apricus exclusive rights to develop and commercialize Vitaros in the U.S in exchange for a $1 million upfront payment and a future $1.5 million regulatory milestone payable to Allergan. Upon FDA acceptance of the NDA for Vitaros, Allergan may elect to exercise a one-time opt-in right to assume all future marketing and selling activities in the United States. If Allergan exercises its opt-in right, Apricus may receive up to a total of $25 million in upfront and potential launch milestone payments, plus a double-digit royalty on net sales of Vitaros. If Allergan elects not to exercise its opt-in right, Apricus may commercialize Vitaros and in return will pay Allergan a double-digit royalty on net sales of Vitaros. Allergan retains the right to launch a future authorized generic under a profit share structure with Apricus.
Apricus Biosciences, Inc. is a biopharmaceutical company advancing innovative medicines in urology and rheumatology. Apricus' lead commercial 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 Mylan NV, Takeda Pharmaceuticals International GmbH, Hexal AG (Sandoz), Recordati Ireland Ltd. (Recordati S.p.A.), Bracco S.p.A. and Laboratoires Majorelle. Apricus' second-generation room temperature Vitaros is under development.
Allergan plc, headquartered in Dublin, Ireland, is a global pharmaceutical company and a leader in a new industry model—Growth Pharma. Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world. Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world's third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.