SAN DIEGO, Jan. 14, 2011 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc., ("Apricus Bio") (Nasdaq:APRI) today announced that the Japanese Patent Office recently issued a Decision to Grant a Patent for the Company's development of a topical cream that utilizes vasoactive prostaglandin E to treat premature ejaculation ("PE"), entitled, "Compositions and Methods for the Treatment of Premature Ejaculation." This patent, when issued, will provide Japanese patent protection until March 2024, and is one in a series of issued patents and pending applications that Apricus Bio owns in the male sexual dysfunction field utilizing its proprietary NexACT® technology, which includes its Vitaros® product to treat erectile dysfunction ("ED"), among others in research and development.
Commenting on today's news, Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio, stated, "We are very pleased with this patent allowance in Japan for the use of vasoactive prostaglandin E to treat PE, which includes the same pharmaceutical composition as Vitaros®, combined with a local anesthetic. While we are aggressively pursuing licensing applications for Vitaros®, we are also developing related products utilizing our NexACT® technology that may add to the value of our existing portfolio of drugs to treat sexual dysfunction. We are very excited about the issuance of this newest patent and we are actively seeking patent protection for this PE application in the U.S. and in other countries."
Currently approved by Health Canada for marketing and sales for patients with ED, Vitaros®, a topical cream, incorporates alprostadil, a well-recognized vasodilator currently marketed by other companies as an injectable product or an intra-urethral insert. Vitaros® has been studied in over 3,300 patients, including difficult to treat populations such as those with diabetes, cardiac problems, sildenafil (Viagra®) failures and post prostatectomy patients. Vitaros® has demonstrated clinical efficacy and an excellent safety profile versus the currently approved oral therapies, and is not contraindicated for patients taking alpha blockers or nitrate medication. Viagra® is a registered trademark of Pfizer, Inc.
Apricus Bio is currently studying the use of vasoactive prostaglandin E, combined with and without local anesthetics, to develop a topical cream to treat premature ejaculation. The Company has completed three clinical studies to date on this application, including two single-blind studies and one double-blind study.
The Company's PE patent portfolio currently consists of three issued patents (Australia, Singapore and soon-to- be Japan) and nine pending applications (the US, Canada, Europe, Mexico, Brazil, China, Hong Kong, South Korea and Israel).
According to Datamonitor 2010, "Premature ejaculation is a commonly yet poorly understood and defined male condition. Prevalence estimates vary greatly from 4% to 29% as stated by a study done by Simons and Carey (2001), according to the different definitions used. The disorder is currently severely undertreated and off-label prescription of selective serontonin reuptake inhibitors("SSRIs") is the most common treatment pathway in the seven major markets."
About Apricus Biosciences, Inc.
Backed by NexMed, USA and Bio-Quant, Inc., its revenue generating CRO business, Apricus Bio 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. Future growth is expected to be driven primarily through out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies, worldwide. Concurrently, the Company is seeking to monetize its existing product pipeline, including its approved drug erectile dysfunction treatment, Vitaros®, as well as compounds in development from pre-clinical through Phase 3, currently focused on dermatology, sexual dysfunction and cancer. For further information on Apricus Bio and its subsidiaries, visit http://www.apricusbio.com.
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 obtain and/or enforce patent coverage in major markets, to develop products from its patented technology and to successfully enter into partnership agreements for its product candidates, its Vitaros® product and its NexACT® platform technology. 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.