SAN DIEGO, Nov. 3, 2014 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines to meet the needs of patients, today announced the launch of Vytaros® in Belgium by the Sandoz Division of the Novartis Group of Companies (“Sandoz”). Apricus’ novel topical on-demand treatment for erectile dysfunction (“ED”), being marketed in Belgium as Vytaros, is also marketed in other European countries as Vitaros®. Belgium will be the third territory in which Sandoz is launching the product in the European Union (the “EU”), following successful launches by Apricus’ partners Takeda in the United Kingdom (the “UK”), and by Sandoz in Germany and Sweden. The product is currently approved in ten countries in Europe, including major ED markets such as the aforementioned and France, Italy and Spain. The Company expects additional launches by its partners in these approved countries into 2015.
Richard Pascoe, Chief Executive Officer of Apricus, commented, “We are pleased to announce the launch of our novel ED treatment, Vitaros, in Belgium by our partner Sandoz following their successful introduction of the product in Germany and Sweden earlier this year. This launch represents Sandoz’ continued commitment to our partnership and to this medical need.” Mr. Pascoe continued, “Moreover, we look forward to additional launches of Vitaros into 2015 by our partners, including Sandoz, in the remaining European territories where Vitaros is approved.”
According to the most recent estimates, the European ED market in 2013 was above $1.3 billion, and analyst estimates for ex-US sales of the product are approximately $300 million at peak.
In December 2013, Apricus expanded its exclusive license agreement with Hexal AG, an affiliate within Sandoz, for the commercialization of the product 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 the product in Germany and the Expanded Territory, which includes up to $4.5 million in new upfront and launch milestone compensation for the Expanded Territory. The successful launch of Vytaros in Belgium results in a $500,000 launch milestone payment to Apricus.
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 the product 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 commercialized in several countries in Europe. Apricus’ marketing partners for Vitaros 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. In October 2014, Apricus gained U.S. development and commercialization rights for fispemifene, a selective estrogen receptor modulator, in Phase 2 development.
For further information on Apricus, visit 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 Vytaros®/Vitaros® in various countries by Apricus’ commercial partners; the potential for the product to achieve commercial success generally or in any specific territory; and the size of the commercial opportunity for the product, particularly in Belgium. 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 its commercial partners, such as Sandoz, to carry out the commercial launch of the product 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 product; 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 akolhatkar@burnsmc.com Media: Justin Jackson jjackson@burnsmc.com Burns McClellan (212) 213-0006 Retail: Chris Eddy, David Collins apri@catalyst-ir.com Catalyst Global (212) 924-9800
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