To Be Commercialized in Italy as Vitaros®
SAN DIEGO, Sept. 1, 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 Italy by Bracco SpA. Vitaros, Apricus’ novel topical on-demand treatment for erectile dysfunction (“ED”), is also marketed under the trademark Vytaros® in Belgium and Virirec™ in Spain. This is the seventh country in the European Union in which the product has been launched, including France, Italy, Germany, the United Kingdom, Spain, Belgium and Sweden. In total, Vitaros is currently approved under the European Decentralized Procedure (“DCP”) in twenty-two countries, of which fourteen have further approved Vitaros for commercialization at the national phase level of the DCP approval process.
Richard Pascoe, Chief Executive Officer of Apricus, commented, “We are pleased to announce Bracco’s launch of Vitaros, the first on-demand topical treatment, in Italy, Europe’s second largest ED treatment market which Bracco estimates to be approximately $135 million. As another contributor towards the positive momentum of commercialization by our partners, which recently produced 103% growth in units quarter over quarter, Bracco plans to implement a strong promotional strategy targeted at physicians across Italy. With this news, the product is now launched in the five largest markets in Europe.”
In December 2010, Apricus signed an exclusive license agreement with Bracco to market Vitaros, in Italy, Vatican City and San Marino (the “Territory”). Under the terms of the agreement, Apricus has received $1.3 million in up-front and milestone payments from Bracco. Apricus is also eligible to receive milestone payments on future sales, plus double-digit tiered royalties based on Bracco’s net sales of the product in the Territory. In exchange, Bracco has the exclusive right to commercialize Vitaros in the Territory. In addition, Bracco has agreed to certain minimum marketing commitments for Vitaros.
Bracco is an international Group active in the healthcare sector through Bracco Imaging (Diagnostic Imaging), Pharma (prescription and over the counter drugs), Acist Medical Systems (medical devices and advanced imaging agents injection systems based in Minneapolis, USA), and the Centro Diagnostico Italiano diagnostic clinic in Milan. It has more than 3,300 employees and annual total consolidated revenues of over 1.1 billion euros, of which 75% is from international sales, and it is present worldwide. In the Research and Innovation area, the company invests approximately 9% of reference turnover in the imaging diagnostics and medical devices sectors and has a portfolio comprising over 1,800 patents.
For further information on Bracco and its subsidiaries, visit http://www.bracco.com.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (Nasdaq:APRI) is a biopharmaceutical company advancing innovative medicines in urology and rheumatology. Apricus has initiated a Phase 2b trial for fispemifene, a selective estrogen receptor modulator for the treatment of symptomatic male secondary hypogonadism, and plans to conduct additional studies in other urological conditions. Apricus recently completed enrollment in a Phase 2a trial for RayVa™, its product candidate for the treatment of the circulatory disorder Raynaud’s phenomenon. Apricus’ lead commercial 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.
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 potential for Vitaros to achieve commercial success generally or in any specific territory, including Italy; the potential for the DCP approvals to enhance the value of Vitaros for Apricus’ partners and shareholders; the size of the commercial opportunity for Vitaros; Vitaros’ ability to capture market share in Europe; 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 Bracco to carry out the commercial launch or grow sales of Vitaros in Italy; the effect of the previously-reported out-of-stock situation for Vitaros in Germany and the potential that Apricus’ partner there, Sandoz, does not resume ordering product for Germany or other countries pending the results of an ongoing out-of-specification investigation by our contract manufacturer; Apricus’ ability to have its product Vitaros be approved by relevant regulatory authorities in Europe and in other countries, such as national phase approvals for Vitaros in the additional CMS territories; 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; 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.
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