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jeudi 19 janvier 2012 à 11h22

Apricus Biosciences Announces Allowance of Israeli Patent, Expanding Its Patent Portfolio for the Topical Treatment of Premature Ejaculation (AcT)


SAN DIEGO, Jan. 17, 2012 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) (http://www.apricusbio.com) announced today that the Israeli Patent Office recently issued a Notice of Allowance to grant a patent for the Company's development of a topical cream utilizing vasoactive prostaglandin E to treat premature ejaculation ("PE"). When issued, the patent, entitled, "Compositions and Methods for the Treatment of Premature Ejaculation," will provide Israeli patent protection until March 2024. It 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, Chairman, President and Chief Executive Officer of Apricus Bio, stated, "We are very pleased with the allowance of this patent in Israel for the use of vasoactive prostaglandin E to treat PE. This patent includes the same pharmaceutical composition as found in Apricus Bio's Vitaros® product for ED combined with a local anesthetic and represents our tenth patent granted in that country on our NexACT® technology. Our proprietary NexACT® technology has enabled the Company to pursue and enter into partnerships for the development and commercialization of Vitaros® and other NexACT® products. We look forward to expanding our PE patent portfolio and to speaking with potential partners regarding the development and commercialization of pharmaceutical products for the treatment of PE in key countries throughout the world."

Vitaros® has been approved by Health Canada for marketing and sales for patients with ED and the Company has filed for marketing approval for the drug for this indication in the European Union and Switzerland. Vitaros® is a topical cream that incorporates alprostadil, a well-recognized vasodilator currently marketed by other companies as an injectable product or an intra-urethral insert. The drug 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 PE. To date, the Company has completed three clinical studies for this application, including two single-blind studies and one double-blind study.

The Company's PE patent portfolio currently consists of five issued patents (Australia, Singapore, Japan, Korea and soon-to-be Israel) and seven pending applications (the U.S., Canada, Europe, Mexico, Brazil, China and Hong Kong).

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.

Apricus Bio is a San Diego-based, revenue-generating, specialty pharmaceutical company, with commercial products and a broad pipeline across numerous therapeutic classes.

Revenues and growth are driven from the sales of the Company's commercial products through its Apricus Pharmaceuticals USA, Inc. and NexMed (USA), Inc. subsidiaries and through out-licensing in certain territories of its product pipeline and NexACT® technology. Apricus Bio's current pipeline includes Vitaros®, approved in Canada for the treatment of erectile dysfunction, Totect® the only drug approved in the US for the treatment of anthracycline extravasation, as well as compounds in development from pre-clinical through pre-registration currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Consumer Healthcare.

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.

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 and their products and product candidates, to have its products and product candidates approved by relevant regulatory authorities, including Israel, to successfully commercialize such NexACT® products and product candidates and to achieve its development, commercialization and financial goals in Israel and other countries. 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 Bio Contacts:
Ed Cox, V.P. Investor Relations &
Corporate Development
Apricus Biosciences
(858) 848-4249
ecox@apricusbio.com

Apricus Bio Investor Relations:
Paula Schwartz
Investor Relations
Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com


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Communiqué intégral et original au format PDF :
http://www.actusnews.com/documents_communiques/ACTUS-0-26431-Apricus-Biosciences-Announces-Allowance-of-Israeli-Patent.pdf
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