SAN DIEGO, Dec. 12, 2011 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) announced today that its podium presentation by Dr. Jacques Buvat on Vitaros®, entitled, "Efficacy and Safety of Topical Alprostadil Cream (Vitaros®) in Hypertensive, Diabetic and Cardiac Patients with Male Erectile Dysfunction," was named the Best Clinical Presentation 2011 (Male Sexual Disorder ("MSD')) by the Scientific Committee of the Congress for the European Society of Sexual Medicine ("ESSM") that recently took place in Milan, Italy on December 1-4, 2011. The list of Best Clinical Presentation 2011 awards (MSD) can be viewed online at http://www.essm-congress.org/essm-awards.html.
"We are very pleased that the number one sexual medicine society in Europe has recognized the top quality of our Vitaros® product for erectile dysfunction," said Dr. Bassam Damaj, Chairman, President and Chief Executive Officer of Apricus Bio. "Like the ESSM, we are very excited about the potential that Vitaros® can bring to the treatment of this male sexual problem and we are very pleased that a well-known, worldwide expert, Dr. Buvat, has been one of our biggest advocates in Europe. Since our product competed with oral drugs of other companies to treat this condition, we are very encouraged that our topical treatment could be very competitive in this lucrative field. We are presently working with the relevant European regulatory authorities and our current and potential European partners to bring this important drug to the market."
Dr. Buvat's presentation, which was one of 18 podium presentations at the ESSM event in the MSD category, discussed the overall combined dataset from two pivotal Phase III clinical trials in 1,732 patients suffering from erectile dysfunction ("ED") with special focus on integrated sub-analyses of these trials in patients with hypertension, cardiovascular disease and diabetes.
Dr. Buvat was also presented with an additional Career Award at the ESSM event. "We would like to congratulate Dr. Buvat on this prestigious career award and we would like to thank him again for his advocacy for our product and for his service on our Sexual Dysfunction Clinical Advisory Board," said Dr. Damaj.
Apricus Bio received marketing approval for Vitaros® as a first-line treatment for ED from Health Canada in November 2010 for sales of the product in that country. In April 2011, the Company filed a marketing application in the European Union, under the Decentralized Procedure ("DCP"), for Vitaros® for the treatment of ED, with the Netherlands as its Reference Member State. Under the DCP, approval in a Reference Member State means that a drug may be sold in all of the European Union countries that were filed with the DCP as Concerned Member States. In July 2011, Apricus Bio filed for regulatory approval with Swissmedic, the Swiss Agency for Therapeutic Products for marketing of Vitaros® in that country. Preparations for filing in certain Latin American countries are ongoing.
About Vitaros® and the ED Market
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 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 currently marketed 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.
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, biopharmaceutical 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 Rx Division product pipeline, including its first product, Vitaros®, approved in Canada for the treatment of erectile dysfunction, 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.
The Company also expects to develop and/or acquire and then bring to market additional pharmaceutical products in areas of care that will benefit patient needs worldwide.
The Company is also developing its Consumer Healthcare Division by developing a number of drugs that utilize the Company's NexACT® technology to comply with the FDA's over-the-counter ("OTC") requirements, can be cleared as 510(k) topical creams that are considered to be medical devices or approved as Abbreviated New Drug Applications ("ANDAs") as generic drugs. The Company will also seek to market such drugs through these similar procedures in foreign countries.
For further information on Apricus Bio, visit http://www.apricusbio.com, and for information on its subsidiary please visit http://www.nexmedusa.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 develop its products such as Vitaros® for erectile dysfunction and other 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 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.