SAN DIEGO, April 3, 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 Ministry of Health of Luxembourg has granted national phase approval to Vitaros®, Apricus' novel topical on-demand treatment for erectile dysfunction ("ED").
The Company has now received a total of nine national phase approvals for Vitaros®, including Luxembourg, Belgium, France, Germany, Ireland, Italy, the Netherlands, Sweden and the United Kingdom ("UK") following its broad approval by European health authorities in June 2013. Apricus has an exclusive commercialization partnership in place with Hexal AG, an affiliate within the Sandoz Division of the Novartis Group of Companies ("Sandoz"), for the commercialization of Vitaros® in several European countries, including Luxembourg.
"We are pleased with the continued progress we have made, together with our partners, towards obtaining Vitaros® national phase approvals in Europe," said Richard Pascoe, Chief Executive Officer of Apricus. "We continue to support our partners as they prepare to launch Vitaros® in their respective territories later this year. Importantly, we have successfully manufactured commercial product, which has met all required release and shelf-life specifications for Europe, and we look forward to the planned launch of Vitaros® throughout this year by our partners."
In June 2013, Apricus announced that its marketing application for Vitaros® was approved through the European Decentralized Procedure ("DCP"). Under the DCP, Apricus filed its application for marketing approval designating the Netherlands as the Reference Member State ("RMS") on behalf of nine other European Concerned Member States ("CMS") participating in the procedure. The Company continues to work toward obtaining the remaining national phase approval in Spain.
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 UK, 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 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 products 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
Statements under the Private Securities Litigation Reform Act, as amended: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for 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 erectile dysfunction, such as the room temperature version of Vitaros® and product candidate Femprox® for the treatment of female sexual interest/arousal disorder among others, as well as the timing of such events; the timing of commercial launch of Vitaros® in Europe and Canada; to have its product and product candidates receive additional patent protection and be approved by the relevant regulatory authorities in Europe, the United States, Canada and in other countries, such as national phase approval for Vitaros® in Spain; and the ability to achieve our other development, commercialization and financial goals, including the ability to out-license ex-US rights to Femprox®, develop a pipeline of products and product candidates and further complement our management team and/or board of directors. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. 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 or without charge from the Company.