Vitaros® National Phase Approval Process in Europe Completed
Vitaros® Expected to Launch in Europe and Canada Throughout 2014
SAN DIEGO, April 24, 2014 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a pharmaceutical company focusing on the development and commercialization of novel therapeutics for men's and women's health, today announced that the Spanish Agency for Medicines and Health Products (AEMPS) has granted national phase approval to Vitaros®, Apricus' novel topical on-demand treatment for erectile dysfunction ("ED").
With the approval in Spain, the Company has now received a total of ten national phase approvals for Vitaros®, including Luxembourg, Belgium, France, Germany, Ireland, Italy, the Netherlands, Sweden and the United Kingdom (the "U.K.") following its broad approval by European health authorities in June 2013. Apricus has an exclusive agreement with Recordati for the commercialization of Vitaros® in Spain, Russia, Turkey, Ireland and certain other European and African countries.
"We are pleased to have now been granted national phase approval in all the countries participating in the European Decentralized Procedure ("DCP") process, which followed the Vitaros® approval last year," said Richard Pascoe, Chief Executive Officer of Apricus. "Moreover, we look forward to the first launch of Vitaros® in the United Kingdom, and in other countries where Vitaros® is approved, by our commercial partners."
In June 2013, Apricus announced that its marketing application for Vitaros® was approved through the European DCP. Under the DCP, Apricus filed its application for marketing approval designating the Netherlands as the Reference Member State on behalf of nine other European Concerned Member States participating in the procedure. The Company has now received national phase approval for all ten of the member states.
Once launched, Vitaros® will become the first new and novel ED product in nearly a decade, and with its unique product profile that has the potential to address a large number of patients who cannot or do not respond well to the existing therapies, or who are intolerant to the systemic effects of PDE-5 inhibitors, it is well-positioned for commercial success. Apricus believes that a significant portion of the market remains untreated or under-treated, which represents a substantial commercial opportunity for Vitaros®.
Vitaros® is currently partnered in key markets, including with Takeda in the U.K., Sandoz in Germany, Switzerland and certain countries in Northern Europe, Bracco in Italy, Majorelle in France, Monaco and certain African countries, Recordati in Spain, Russia, Turkey, Ireland and certain other European and African countries, and Abbott in Canada. The Company's existing commercialization partners are preparing for Vitaros® product launches in their respective territories with product launches expected throughout 2014.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI) is a pharmaceutical company focused on the development and commercialization of novel therapeutics for men's and women's health. 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 further enhance the product's commercial value. 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 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®. 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 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.