SAN DIEGO, April 28, 2011 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq:APRI) announced today that it has filed a marketing application in Europe for Vitaros® as a treatment for patients with erectile dysfunction ("ED"). Approval of the application would give Apricus the right to sell Vitaros® in multiple chosen countries in the European Union. "Our goal is to help millions of patients suffering with erectile dysfunction in Europe," said Bassam Damaj, Ph.D., Chairman, President and Chief Executive Officer of Apricus Bio.
Vitaros® has already been approved in Canada for the treatment of erectile dysfunction. Warner Chilcott, which owns the U.S. rights to Vitaros® for ED, has submitted a New Drug Application to the U.S. Food and Drug Administration, requesting approval in the U.S.
Before submitting the European application, Apricus Bio consulted with regulators in the United Kingdom, Germany and the Netherlands, and received positive guidance from each. The application includes positive data from the Company's two Phase III clinical studies of Vitaros® as a treatment for ED, as well as information about the chemistry, manufacturing and controls ("CMC") for the drug.
Under a European system called the "Decentralized Procedure" (DCP), a company files its application for marketing approval of a drug in just one European country, which is designated the Reference Member State (RMS). Apricus Bio has chosen The Netherlands as its RMS. The RMS then evaluates the application and prepares an assessment report that is submitted to other chosen European Union countries for their consideration and approval. The entire process takes approximately 240 days. One of the major advantages of the DCP is that a company may receive identical marketing authorizations for its product in multiple chosen European Member countries at the same time.
"This submission is another major milestone for the Company," said Damaj. "We look forward to working with the European regulatory authorities as they review our application."
About Vitaros® and the ED Market
According to IMS Health data, the annual ED market in Europe in 2010 was about $1.2 billion. The current leading drugs 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 -- much faster than the results achieved 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® was 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," noted 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 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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