SAN DIEGO, June 16, 2014 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a pharmaceutical company focusing on the development and commercialization of novel therapeutics for men's and women's health, today announced the launch of Vitaros®, Apricus' novel topical on-demand treatment for erectile dysfunction ("ED"). Vitaros will be marketed in the United Kingdom by Takeda Pharmaceuticals International GmbH.
Richard Pascoe, Chief Executive Officer of Apricus, commented, "We are pleased to announce the launch of Apricus' first product, Vitaros, in the United Kingdom. This launch marks a significant milestone for Apricus and its partners, as it exemplifies our commitment to bringing novel products to market that address unmet need. With the launch of Vitaros, the first and only on-demand topical treatment for erectile dysfunction, we look forward to a series of Vitaros launches by our commercial partners in Europe and Canada throughout 2014."
The launch of Vitaros in the United Kingdom marks the availability of the first novel ED treatment in Europe in nearly a decade. According to IMS Health, the ED market in the United Kingdom was approximately $200 million in 2013 based on prescription sales, making it one of the largest ED markets in Europe. The European PDE-5 inhibitor market is approximately $1.5 billion as estimated by IMS Health, and analyst estimates for ex-US Vitaros sales are in the range of $300 million at peak.
Apricus has received multiple commercial product orders of Vitaros from its partners and is currently manufacturing multiple product batches through its contract manufacturer in Canada to support launches in Europe. The commercialization of Vitaros has been fully licensed to these partners, with Apricus positioned to earn tiered double-digit royalties and more than $200 million in potential milestone payments.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI) is a pharmaceutical company focused on the development and commercialization of novel therapeutics for men's and women's health. The Company's lead product, Vitaros, for the treatment of erectile dysfunction, is approved in Europe and Canada and will be commercialized by Apricus' marketing partners, which include Abbott Laboratories Limited, Takeda Pharmaceuticals International GmbH, Hexal AG (Sandoz), Recordati Ireland Ltd. (Recordati S.p.A.), Bracco S.p.A. and Laboratoires Majorelle. The Company's second-generation Vitaros® room temperature device is under development and is expected to enhance the product's commercial value. Femprox™, the Company's product candidate for the treatment of female sexual interest/arousal disorder, has successfully completed an approximately 400-subject proof-of-concept study. The Company is currently seeking a strategic partner for Femprox. RayVa™, the Company's product candidate for the treatment of Raynaud's phenomenon, recently received FDA clearance to begin clinical studies. The Company intends to begin a Phase 2a trial with RayVa in the second half of 2014.
For further information on Apricus, visit http://www.apricusbio.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 of planned launches of Vitaros® in various countries by Apricus' commercial partners; the potential for Vitaros® to achieve commercial success generally or in any specific territory, including Apricus' receipt of royalties and potential milestone payments from its commercial partners; the size of the commercial opportunity for Vitaros; and expectations regarding the commercial value and timing of future product development. Actual results could differ from those projected in any forward-looking statements due to a variety of reasons that are outside the control of the Company, including, but not limited to: Apricus' dependence on Takeda for sales of Vitaros in the United Kingdom and Apricus' other commercial partners to carry out the commercial launch of Vitaros in other 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 obtain and maintain intellectual property protection for Vitaros; Apricus' and its commercial partners reliance on third party manufactures for the supply and manufacture of Vitaros and its product candidates; risks and uncertainties related to Apricus' ability to further develop its second-generation Vitaros room temperature device and its product candidate RayVa for the treatment of Raynaud's phenomenon; Apricus' ability to raise additional funding that it may need to continue to pursue its commercial and business development plans; 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 the Company's 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 the Company.