Apricus Eligible to Receive an Additional $3.6 Million in Upfront and Pre-Commercialization Milestone Payments for the Expanded Territory
Apricus and Sandoz Agree to Mutually Terminate License Agreement
SAN DIEGO, July 25, 2016 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that it has further expanded its exclusive distribution agreement with Ferring Pharmaceuticals (“Ferring”), for the commercialization of Vitaros®, Apricus’ novel topical on-demand treatment for erectile dysfunction (“ED”). This amendment is in addition to the in-place collaboration established with Ferring in Latin America in 2015, and the recently announced expansion for the United Kingdom. This expanded agreement includes Germany, Austria, Belgium, Denmark, Finland, Iceland, Luxembourg, Norway, the Netherlands, Sweden, Switzerland, Malaysia, Indonesia, the Philippines, Thailand, Taiwan, Vietnam, Hong Kong, Singapore and Korea. Additionally, along with announcing the mutual termination of the Sandoz license, all three parties have entered into a services agreement whereby the existing marketing authorizations will be transferred to Ferring and Ferring will thereafter be responsible for marketing the brand and seeking additional country approvals.
Apricus will be eligible to receive an additional $3.6 million in upfront and pre-commercialization milestone payments, and up to an additional $1.5 million in launch milestone payments, for the expanded territory compared to Apricus’ prior contract with Ferring. In combination with the terms of the previously signed distribution agreement and amendment with Ferring, Apricus is eligible to receive up to $34 million in combined upfront, regulatory, launch and sales milestone payments, plus high single-digit to low double-digit royalties based on Ferring’s net sales in the territory.
“With the consolidation of these territories, coupled with the previously announced Latin America and UK transactions, we believe Ferring is well positioned to grow the Vitaros brand in key global markets as the first and only topical treatment for erectile dysfunction,” said Richard Pascoe, Chief Executive Officer of Apricus. “Ferring now has the ability to launch in the near term in up to eleven countries, and importantly, re-launch in Germany.” Mr. Pascoe continued, “We would like to thank Sandoz for its support of Vitaros and very much look forward to our expanded relationship with Ferring.”
Vitaros is a new entrant into the ED treatment market, offering a product profile making it appealing to certain patients. Vitaros is a topical ED cream that delivers rapid onset (generally 5-30 minutes) and treatment duration of approximately one to two hours. Vitaros’ local delivery provides an alternative for 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.
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 more 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’ commercial product, Vitaros®, for the treatment of erectile dysfunction, is approved in Europe and Canada and is being commercialized in several countries in Europe. In September 2015, Apricus in-licensed the U.S. development and commercialization rights for Vitaros from Allergan. Apricus’ marketing partners for Vitaros include Laboratoires Majorelle, Bracco S.p.A., Recordati Ireland Ltd. (Recordati S.p.A.), Ferring International Center S.A. (Ferring Pharmaceuticals), Mylan NV and Elis Pharmaceuticals Ltd. Apricus currently has one active product candidate, RayVa™, its product candidate for the treatment of the circulatory disorder Raynaud’s phenomenon.
For further information on Apricus, visit http://www.apricusbio.com.
*Vitaros® is a registered trademark of NexMed International Limited. Such trademark is registered in certain countries throughout the world and pending registration in the United States.
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: timing of the transfer of marketing authorizations to Ferring from Sandoz; references to the potential for Vitaros to achieve commercial success generally or in the territory; the timing of the re-launch of Vitaros in Germany; and the potential for Apricus to receive future milestone and royalty revenue. 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 Ferring and its other commercial partners to obtain regulatory approvals, carry out the commercial launch or grow sales of Vitaros in various territories; competition in the ED market and other markets in which Apricus and its partners operate; 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; 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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