SAN DIEGO, Sept. 10, 2015 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that it 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. On February 3, 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, Chief Executive Officer 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 know-how, 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."
Mr. Pascoe will discuss the transaction during his presentation at the Rodman & Renshaw 17th Annual Global Investment Conference on Thursday, September 10, 2015, at 4:40 p.m. Eastern Time. A live audio webcast of the presentation and the presentation slides can be accessed via the Investor Relations section of Apricus' website at www.apricusbio.com.
Terms of the Agreement
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.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing innovative medicines in urology and rheumatology. Apricus has initiated a Phase 2b trial for fispemifene, a selective estrogen receptor modulator for the treatment of symptomatic male secondary hypogonadism, and plans to conduct additional studies in other urological conditions. Apricus recently completed enrollment in a Phase 2a trial for RayVa™, its product candidate for the treatment of the circulatory disorder Raynaud's phenomenon. 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.
For further information on Apricus, visit http://www.apricusbio.com.
About Allergan
Allergan plc headquartered in Dublin, Ireland, is a unique, 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.
For more information, visit Allergan's website at www.allergan.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 and success of the development plan and the regulatory pathway for Vitaros in the U.S.; the size of the commercial opportunity and Vitaros' ability to capture market share in the U.S.; the timing of any acceptance of the NDA related to Vitaros by the FDA; the timing and costs of Apricus' option to assume future marketing and selling activities in the United States; and the potential for Vitaros to achieve commercial success. Actual results could differ from those projected in any forward-looking statements due to a variety of reasons that are outside of Apricus' control, including, but not limited to: Apricus' ability to submit an NDA related to Vitaros to the FDA and to receive FDA approval of Vitaros; the effect of the previously-reported out-of-stock situation for Vitaros in Germany and the potential that Apricus' partner there, Sandoz, does not resume ordering product for Germany or other countries pending the results of an ongoing out-of-specification investigation by our contract manufacturer; its ability to further develop its product Vitaros for the treatment of ED, such as the room temperature version of Vitaros, as well as the timing of such events; Apricus' dependence on its commercial partners to carry out the commercial launch of Vitaros in various territories and the potential for delays in the timing of commercial launch; competition in the ED market and other markets in which Apricus and its partners operate; 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 approval for Vitaros in the U.S.; the fluctuation of currency exchange rates; the potential for adverse reactions to the product; 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 Apricus' 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 Apricus.