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Apricus Biosciences (APRI) Announces The Launch Of Its Topical Treatment For Erectile Dysfunction Vitaros® In Germany By Hexal


8/18/2014 7:10:48 AM

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SAN DIEGO, Aug. 18, 2014 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines to meet the needs of patients, today announced the launch in Germany of Vitaros®, Apricus' novel topical on-demand treatment for erectile dysfunction ("ED"), by Hexal AG, an affiliate within the Sandoz Division of the Novartis Group of Companies ("Sandoz"). Earlier this month, Sandoz launched Vitaros in Sweden.

Richard Pascoe, Chief Executive Officer of Apricus, commented, "We are pleased to announce the launch of Vitaros in Germany, one of the largest ED markets in the European Union. This is the third launch in as many months, following introductions in the United Kingdom and Sweden, and we believe this is another clear signal of the continuing, strong momentum of commercialization in Europe."

According to the most recent and updated figures from IMS Health, the ED market in Germany was over $150 million in 2013. Also according to the most recent estimates, the European ED market in 2013 was above $1.3 billion, and analyst estimates for ex-US Vitaros sales are approximately $300 million at peak.

In December 2013, Apricus expanded its exclusive license agreement with Sandoz for the commercialization of Vitaros in Austria, Belgium, Denmark, Finland, Iceland, Luxemburg, the Netherlands, Norway, Sweden and Switzerland (the "Expanded Territory"), in addition to Germany. Under the terms of the agreement, Apricus is eligible to receive up to approximately $63 million from Sandoz in upfront, regulatory, launch and sales milestone payments for Vitaros in Germany and the Expanded Territory, which includes up to $4.5 million in new upfront and launch milestone compensation for the Expanded Territory.

Apricus continues to receive 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 biopharmaceutical company advancing innovative medicines to meet the needs of patients. 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. The Company recently initiated a Phase 2a trial for RayVa, the Company's product candidate for the treatment of Raynaud's phenomenon. 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.

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 and initial shipments of Vitaros® in various countries by Apricus' commercial partners; the potential for Vitaros to achieve commercial success generally or in any specific territory; and the size of the commercial opportunity for Vitaros, particularly in Germany. 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: 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, such as Sandoz, 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 obtain and maintain intellectual property protection for Vitaros; 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.

CONTACT: Steve Martin Apricus Biosciences Chief Financial Officer ir@apricusbio.com (858) 222-8041 Investors: Angeli Kolhatkar Burns McClellan Senior Vice President akolhatkar@burnsmc.com (212) 213-0006

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