SAN DIEGO, Oct. 1, 2015 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that it has signed an exclusive distribution agreement with Ferring Pharmaceuticals ("Ferring") to market Vitaros™ (alprostadil), its topical on-demand product for the treatment of erectile dysfunction ("ED"), in Latin American countries (the "Territory").
Under the terms of the agreement, Apricus will receive $2.25 million from Ferring in an upfront payment. Apricus is also eligible to receive up to $16 million in regulatory and sales milestone payments, in addition to royalties based on Ferring's net sales of the product in the Territory. In exchange, Ferring will have the exclusive right to commercialize Vitaros in the Territory, which covers Latin America, including certain Caribbean countries. Ferring will be responsible for obtaining all necessary regulatory approvals.
"We look forward to our collaboration with Ferring as they expand the regions in which Vitaros, the first and only topical on-demand treatment for erectile dysfunction, is available," said Richard Pascoe, Chief Executive Officer of Apricus. "We are pleased that we have been able to license Vitaros in yet another important market outside of Europe as we seek to make Vitaros available to men with erectile dysfunction throughout the world who have yet to be treated satisfactorily."
"We are excited by the opportunity to work with Apricus to commercialize Vitaros, an innovative product that complements Ferring's existing portfolio," said Michel Pettigrew, President of the Executive Board and Chief Operating Officer at Ferring. "Vitaros will provide an alternative treatment for men suffering from erectile dysfunction in Latin America, while also allowing us to strengthen our presence in the region."
Vitaros is a new potential entrant into the ED treatment market, offering a range of benefits that make it appealing to a large number of patients. Vitaros is a topical ED cream that delivers rapid onset (generally 5-15 minutes), treatment duration of approximately one hour and a favorable safety profile. Vitaros' local delivery provides an attractive alternative for many patients, but particularly those with complications that preclude them from using the orally delivered systemic treatments or who prefer to avoid the injectable forms of alprostadil.
According to IMS Health, the global ED market in 2014 was in excess of $6.7 billion annually. Outside of the United States, Vitaros has the potential to generate for Apricus over $200 million in future milestone payments, as well as potential royalty revenue on net product sales. Moreover, Apricus intends to leverage Vitaros through additional licensing efforts in key markets in Asia.
About Ferring Pharmaceuticals
Headquartered in Saint-Prex, Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopedics. Ferring has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.
For further information on Ferring or its products, visit www.ferring.com.
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 has completed a Phase 2a trial for RayVa™, its product candidate for the treatment of the circulatory disorder Raynaud's phenomenon, and plans to conduct additional clinical trials in patients with Raynaud's phenomenon secondary to scleroderma. 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 recently in-licensed the U.S. development and commercialization rights for Vitaros from Allergan. Apricus' European marketing partners for Vitaros include Laboratoires Majorelle, Bracco S.p.A., Hexal AG (Sandoz), Takeda Pharmaceuticals International GmbH, Recordati Ireland Ltd. (Recordati S.p.A.) and Ferring International Center S.A. (Ferring Pharmaceuticals). Apricus' second-generation room temperature Vitaros is currently under development.
For further information on Apricus, visit http://www.apricusbio.com.
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 potential for the product to achieve commercial success generally or in any specific territory and for Apricus to receive future milestone and royalty revenue; Apricus' intention to expand licensing efforts in additional markets, such as Asia; and the size of the commercial opportunity for the product, particularly in the Territory. 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' dependence on its commercial partners to carry out the commercial launch or grow sales of Vitaros in various territories, such as Ferring in the Territory, Majorelle in France, Bracco in Italy, Sandoz in Germany, Sweden and Belgium, Takeda in the United Kingdom and Recordati in Spain; competition in the ED market and other markets in which Apricus and its partners operate; 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; Apricus' ability to obtain and maintain intellectual property protection for the product; its ability to further develop its product Vitaros for the treatment of ED, such as the room temperature version of Vitaros; Apricus' ability to raise additional funding that it may need to continue to pursue its commercial and business development plans; the fluctuation of currency exchange rates; the potential for adverse reactions to the product; its ability to negotiate and enter into acceptable terms for new licensing agreements; 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.
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