SAN DIEGO, May 19, 2011 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc., ("Apricus Bio") (Nasdaq:APRI) today announced that it has received guidance from Swissmedic, the Swiss Agency for Therapeutic Products, regarding its submission for filing the regulatory dossier for Vitaros® in Switzerland. Vitaros® is Apricus Bio's proprietary, topically-applied, on-demand treatment for erectile dysfunction ("ED").
Swissmedic is the regulatory authority in Switzerland for medicine and medical devices. Switzerland is not part of the European Medicines Evaluation Agency (EMEA), and marketing drugs in Switzerland requires an independent application and approval from Swissmedic.
"A potential Swissmedic approval could support approvals for Vitaros® for the treatment of ED in several other European countries that, like Switzerland, are not members of the European Union," noted Dr. Bassam Demaj, Chairman, Chief Executive Officer and President of Apricus Bio. "The filing in Switzerland represents yet another milestone toward our goal of making Vitaros® available on a worldwide basis."
The Company has previously received marketing approval for Vitaros® as a first-line treatment for ED from Health Canada in November 2011, for sales of the product in that country.
In April 2011, Apricus Bio announced that that it filed a marketing application in the European Union for Vitaros® as a treatment for patients with ED. Under the European Union's system called the "Decentralized Procedure" ("DCP"), Apricus Bio filed its application for marketing approval of a drug in just one European Union country, the Netherlands, which it designated as its Reference Member State (RMS). The RMS evaluates the application and prepares an assessment report that will be submitted to other chosen European Union countries for their consideration and approval. Pursuant to the DCP, a company may receive identical marketing authorizations for its product in multiple chosen European Union Member countries at the same time.
In other regulatory news regarding another of Apricus Bio's products, the Company has received a preliminary letter from the U.S. Food and Drug Administration ("FDA") related to the orphan designation request filed for RayVa™, for the treatment of Raynaud's phenomenon in patients with systemic sclerosis. The FDA has requested additional information on the number of patients, as well as a plan to limit the potential use of RayVa™ by other patients who do not suffer from this condition.
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego based revenue-generating pharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes.
Revenues and growth are driven from out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies worldwide. In addition, the Company is seeking to monetize its existing product pipeline, including its first product, Vitaros®, approved in Canada for the treatment of erectile dysfunction, which is currently expected to be available on the Canadian market in 2011, as well as compounds in development from pre-clinical through Phase III, currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Cosmeceuticals among others.
For further information on Apricus Bio, visit http://www.apricusbio.com and for information on its subsidiaries please visit www.nexmedusa.com or www.bio-quant.com. You can also receive information at http://twitter.com/apricusbio and http://facebook.com/apricusbio.
Apricus Bio's Forward-Looking Statement Safe Harbor
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 development products and product candidates, to have its products such as Vitaros® , RayVa™ among others and product candidates approved by relevant regulatory authorities, to successfully commercialize such products and product candidates and to achieve its other development, commercialization and FINANCIAL goals. 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.
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