SAN DIEGO, Oct. 19, 2011 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) (http://www.apricusbio.com) announced today that the Korean 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 Korean 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, President and Chief Executive Officer of Apricus Bio, commented, "We are very pleased with this patent allowance in South Korea for the use of vasoactive prostaglandin E to treat PE. This allowed patent includes the same pharmaceutical composition as Vitaros®, combined with a local anesthetic. We are aggressively seeking marketing approval from various regulatory authorities and pursuing partnership transaction applications for Vitaros® for erectile dysfunction, and are also developing related products utilizing our NexACT® technology that may add to the value of our existing portfolio of drugs to treat various types of sexual dysfunction. In addition to the issuance of this new Korean patent, we are actively seeking patent protection for this PE application in the U.S. and in other key countries."
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 four issued patents (Australia, Singapore, Japan and soon-to-be Korea) and eight pending applications (the U.S., Canada, Europe, Mexico, Brazil, China, Hong Kong 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.
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, 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.
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 www.nexmedusa.com. Information may also be found 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 conduct or part with other companies to conduct research that demonstrates the effectiveness of its NexACT® drug delivery technology to enhance the delivery of drugs through various routes of administration such as transdermal, transbuccal among others, its ability to receive issued patents on its NexACT® technology and products, develop such patented technology into product candidates such as Vitaros® for premature ejaculation, have its Rx Division products and product candidates approved by relevant regulatory authorities and its Consumer Healthcare Division products either approved or cleared by relevant regulatory authorities or be in compliance with appropriate regulatory requirements, to successfully manufacture and commercialize such Rx Division products along with its Consumer Healthcare Division 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 Bio, Inc.
Apricus Bio Investor Relations
Rx Communications Group, LLC