SAN DIEGO, May 19, 2011 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq:APRI) announced today that it will file a marketing application in Switzerland for Vitaros® as a treatment for patients with erectile dysfunction ("ED"), based on a positive response it has received from Swissmedic, the Swiss Agency for Therapeutic Products.
In April 2011, Apricus Bio filed a marketing application in the European Union under the Decentralized Procedure ("DCP") for Vitaros® for the treatment of ED. Under the DCP, approval in a Reference Member State means that a drug may be sold in all of the European Union countries. Switzerland, however, is not part of the European Medicines Evaluation Agency ("EMEA"). Marketing drugs in that country requires an independent application and approval from Swissmedic. Apricus asked the Swiss agency for guidance on whether to file an application, and received an affirmative response. The Company expects to file the application in the next two to three months.
"A Swissmedic approval could support approvals for Vitaros® for the treatment of ED in several other European countries, like Switzerland that are not members of the European Union," says Dr. Bassam Damaj, Chairman, Chief Executive Officer and President of Apricus Bio. "The filing in Switzerland is another step for us to achieve our goal of making Vitaros® available in as many countries as possible."
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 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 drug designation request filed for Apricus Bio's RayVa™ product 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 Vitaros® for ED
The current leading drugs for erectile dysfunction are Viagra®, Cialis® and Levitra®, which are taken in pill form and work by inhibiting an enzyme called PDE5.
There is still a need for new, safe and effective treatments, however, especially for those patients who cannot or do not respond well to oral medication. Vitaros® differs from Viagra®, Cialis® and Levitra® in two ways. Instead of being a pill, Vitaros® is applied directly to the penis as a cream. The topical application helps to reduce side effects and offers men who do not do well with the existing drugs a patient-friendly alternative.
Second, Vitaros® operates by a different biochemical mechanism than oral ED medications. It contains a previously marketed ED drug known by the chemical name of alprostadil. When absorbed through the skin, alprostadil directly boosts blood flow, thereby causing an erection within minutes, which the Company believes is much faster than the results from the oral treatments.
Alprostadil is currently marketed as an injectable drug or as a suppository inserted into the urethra. The key innovation behind Vitaros® is combining alprostadil with Apricus Bio's NexACT® delivery technology, which allows the drug to pass through the skin and makes the treatment much easier to apply.
In clinical studies, Vitaros® worked in patients suffering from mild to severe ED, including men who did not respond to Viagra®. The side effects reported were localized and transient. "We believe that Vitaros® will be an attractive alternative to the oral PDE5 inhibitors for many patients with erectile dysfunction," stated Damaj.
Viagra® is a registered trademark of Pfizer, Inc.; Cialis® is a registered trademark of Lilly, USA; Levitra®, is a registered trademark of Bayer A.G.; and Vitaros® is a registered trademark in Canada held by Apricus Bio, and in the U.S. held by Warner Chilcott Company.
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.
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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.
CONTACT: Apricus Biosciences, Inc. Edward Cox, V.P. Corporate Development & Investor Relations, Apricus Biosciences, Inc. (858) 848-4249 ecox@apricusbio.com Apricus Bio Investor Relations Paula Schwartz Rx Communications Group, LLC (917) 322-2216 pschwartz@rxir.com