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SAN DIEGO, Aug. 10, 2015 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that Vitaros®, a topical cream indicated for the treatment of patients with erectile dysfunction ("ED"), has been approved through the European Decentralized Procedure ("DCP") in twelve additional countries. Those countries are: Austria, Cyprus, the Czech Republic, Denmark, Finland, Greece, Iceland, Norway, Poland, Portugal, Romania and the Slovak Republic. Apricus' commercialization partners that hold the license for these additional territories will be responsible for the next step of obtaining national phase approvals in order to make Vitaros ready to launch.
In 2013, Vitaros was approved under a separate DCP in Belgium, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Spain, Sweden and the United Kingdom. Under the DCP, Apricus or its partners filed applications for marketing approval designating the Netherlands as the Reference Member State on behalf the twenty-one other European Concerned Member States participating in the procedure.
"Since the first European approval of Vitaros in 2013, together with our commercial partners, we have made significant progress in making Vitaros available to men suffering from erectile dysfunction in Europe. These additional approvals, under the DCP, further enhance the value of Vitaros for our partners and potentially our shareholders," said Richard W. Pascoe, Chief Executive Officer of Apricus. "Vitaros has a unique product profile that meets the needs of a large number of patients suffering from erectile dysfunction to include those patients who are intolerant to or do not respond to current treatment options. With its rapid onset of action and unique topical delivery, we believe that Vitaros will capture a significant share of the approximately $1 billion PDE-5 inhibitor market in Europe."
"Moreover, with the recent successful launches in Spain and France, Vitaros unit sales in Europe more than doubling from the first quarter of 2015 to the second quarter of 2015, and an expected launch in Italy later this year, we are confident that Vitaros will continue to generate meaningful revenue for Apricus to help advance our clinical-stage pipeline."
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (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 timing of planned launches of Vitaros® in various countries by Apricus' commercial partners, including Italy; the potential for Vitaros to achieve commercial success generally or in any specific territory; the potential for the new 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; whether Vitaros will generate meaningful revenue to help Apricus' clinical-stage pipeline; the potential for Apricus to receive future milestone and royalty revenue and the planned commencement of additional studies in other urological conditions 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: 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; Apricus' dependence on its commercial partners 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 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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