SAN DIEGO, May 28, 2015 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced the launch of Vitaros® in France by Laboratoires Majorelle. Vitaros, Apricus’ novel topical on-demand treatment for erectile dysfunction (“ED”), is also marketed as Vytaros® in Belgium and Virirec™ in Spain. France is the sixth territory in the European Union in which the product has been launched. This follows the issuance of a positive opinion for the reimbursement and the retail pharmacy and hospital listing of Vitaros by the French National Health Insurance Transparency Commission (Commission de la Transparence) of the French National Health Authority (Haute Autorité de Santé). Laboratoires Majorelle is now waiting for the subsequent publication in France’s Journal Officiel of the pricing and reimbursement of Vitaros by the Economic Committee of Healthcare Products (Comité Economique des Produits de Santé). This is the final step in the reimbursement process for a new medicine in France.
“We are thrilled to announce Majorelle’s launch of Vitaros, the first on-demand topical treatment of ED, in France, the largest ED market in Europe,” said Richard Pascoe, Chief Executive Officer. Majorelle has developed a comprehensive and creative marketing strategy that they believe will lead to a rapid adoption of Vitaros in France by leading urologists and the patients that they treat. With this launch, Vitaros is now available in six countries in Europe, including four of the five largest markets.
In November 2013, Apricus signed an exclusive license agreement with Majorelle to market Vitaros in France, Monaco and certain African countries (the “Territory”). Under the terms of the agreement, Apricus has received $2 million in up-front and milestone payments from Majorelle. Apricus is also eligible to receive up to approximately $19 million in regulatory and sales milestone payments based on current exchange rates, plus double-digit tiered royalties on Majorelle’s net sales of the product in the Territory. In exchange, Majorelle has the exclusive right to commercialize Vitaros in the Territory. In addition, Majorelle has agreed to certain minimum marketing commitments for Vitaros, including the expansion of its existing sales force in France.
About Laboratoires Majorelle
Laboratoires Majorelle was founded in 2001 and is headquartered in Paris, France. Majorelle is recognized for their expertise in launching products through custom-tailored strategies. Majorelle has a strong, well-experienced commercialization team dedicated to urology and reproductive products for both males and females. The company innovates daily to increase treatment success rates and contribute to improving the care pathway for patients and the healthcare professionals who help them.
For further information on Majorelle, visit http://www.laboratoires-majorelle.com.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing innovative medicines in urology and rheumatology. Apricus’ lead product, Vitaros®, for the treatment of erectile dysfunction, is approved in Europe and Canada and is being commercialized in several countries in Europe. Apricus’ marketing partners for Vitaros include Mylan NV, Takeda Pharmaceuticals International GmbH, Hexal AG (Sandoz), Recordati Ireland Ltd. (Recordati S.p.A.), Bracco S.p.A. and Laboratoires Majorelle. Apricus’ second-generation room temperature Vitaros is under development. Apricus commenced a Phase 2a trial for RayVa™, its product candidate for the treatment of the circulatory disorder Raynaud’s phenomenon. Additionally, Apricus plans to initiate a Phase 2 trial for fispemifene, a selective estrogen receptor modulator for the treatment of male secondary hypogonadism, chronic prostatitis and lower urinary tract symptoms.
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: the timing of Majorelle’s receipt of reimbursement pricing for the product in France; the adoption of Vitaros® by urologists and patients in France and the potential for Apricus to receive future milestone and royalty revenue; and the planned commencement of a Phase 2 trial for fispemifene. 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 Majorelle to carry out the commercial launch or grow sales of Vitaros in France; 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; 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.
CONTACT: Institutional Investors: Angeli Kolhatkar angeli@areciaadvisors.com Arecia Advisors (917) 387-4770 Retail Investors: Chris Eddy, David Collins apri@catalyst-ir.com Catalyst Global (212) 924-9800
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