Femprox(R) Phase III Clinical Data From Apricus Biosciences Chosen for a Presentation at the European Society for Sexual Medicine


SAN DIEGO, Nov. 14, 2011 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) announced today the acceptance of an abstract entitled, "Age Group Analysis of a Randomized, Double-blind, Phase 3 study of Femprox®, a Topical Alprostadil Cream with a Novel Transdermal Delivery Technology (Nexact®) for the Treatment of Female Sexual Arousal Disorder ("FSAD")," as a Highlighted Poster, followed by an oral presentation at the upcoming European Society of Sexual Medicine ("ESSM") conference taking place in Milan, Italy, December 1-4, 2011.

Dr. Ignacio Moncada will present the poster with a short oral presentation and question and answer session on Friday December 2, 2011, during the Women's Sexual Health Session (HP-03-008), scheduled to take place from 3:00 pm to 3:30 pm CET in Exhibition Hall B Area 1.  Dr. Moncada is President of the Spanish Association of Sexual Health and a member of the Guidelines Committee for Sexual Dysfunctions of the European Association of Urology. He is also the author of numerous chapters in related reference books and a member of the Company's Sexual Dysfunction Clinical Advisory Board.

The poster presentation will discuss an age group analysis of primary and secondary endpoints of the completed Phase III clinical trial to provide further evidence of the statistically significant efficacy and safety profile of Apricus' investigational drug, Femprox® (topical alprostadil cream 0.4 %) in this clinical trial. "The efficacy and safety of our Femprox® drug candidate is increasingly being recognized by the clinical community worldwide; the endorsement of the leaders of the heads of the sexual societies worldwide is a testimony of the superiority and the potential of our drug," said Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio.

About Femprox®

Femprox® is an alprostadil-based cream intended for the treatment of FSAD. Apricus Bio has completed nine clinical studies to date, including one, 98-patient Phase II study in the U.S. and a 400-patient Phase III study in China.

It is the Company's understanding that no product is currently approved for FSAD in the U.S., a persistent or recurring inability to attain, or maintain adequate sexual excitement, causing personal distress.

Femprox® exerts a local, relaxant effect on vulvar and clitoral blood vessels in women, leading to increased blood flow. The resultant increase in lubrication and sensory feedback is believed to produce a clinically significant increase in sexual arousal in women with FSAD.

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 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 such as Femprox® for Female Sexual Arousal Disorder 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.



            

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