Apricus Biosciences Announces Oral Presentation of Efficacy and Clinical Safety Data for Vitaros(R) and Femprox(R) at the African Society for Sexual Medicine Conference (AcT)

SAN DIEGO, Dec. 15, 2011 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) announced today the planned, oral presentation of clinical efficacy and safety data for both of its lead products in sexual medicine -- Vitaros® for erectile dysfunction ("ED") and Femprox® for Female Sexual Arousal Disorder ("FSAD") -- at the Biennial Meeting of the African Society for Sexual Medicine ("ASSM"), taking place in Dakar, Senegal, from December 15 to December 17, 2011.

Specifically, Dr. Jacques Buvat, a member of the Company's Sexual Dysfunction Clinical Advisory Board, will present the overall combined dataset from two pivotal Phase III clinical trials in 1,732 patients suffering from ED, with special focus and sub-analyses in patients with hypertension, cardiovascular disease and diabetes. In the State of the Art lecture session, "Female Sexual Dysfunction Update," Dr. Buvat will also discuss an age group analysis of primary and secondary endpoints of a 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.

"We are very pleased with the warm reception Dr. Buvat and other presenters of our Vitaros® and Femprox® products have been experiencing at recent sexual medicine conferences throughout the world," said Dr. Bassam Damaj, Chairman, President and Chief Executive Officer of Apricus Bio. "As we announced last week, Dr. Buvat's presentation on Vitaros® 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"), which recently took place in Milan, Italy from December 1-4, 2011. We are very happy that experts in the field of sexual medicine are recognizing the important impact that we believe Vitaros® and Femprox® can make in this field." 

Dr. Damaj continued, "We are very excited about discussing these products with leading experts in Africa at the conference and in other meetings in that region. In addition, as we continue to work towards closing our fourth worldwide partnership for Vitaros® for ED as planned in Canada in 2011, we look forward to our continued discussions with potential partners in these African countries."

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 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, 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.

CONTACT: Apricus Biosciences, Inc.
Edward Cox, V.P.
Investor Relations & Corporate Development
Apricus Bio, Inc.
(858) 848-4249
ecox@apricusbio.com

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