Apricus Biosciences Announces That Its NexACT(R) Partner Exodos Life Sciences Has Completed Its pre-IND Meeting With the FDA (AcT)

Exodos Moves Closer to Filing a U.S. Investigational New Drug Application for Its Topically-Applied Formulation of Ketoprofen for Pain Relief

SAN DIEGO, Nov. 15, 2011 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) announced today that its NexACT® out-licensing partner, Exodos Life Science Limited Partnership ("Exodos"), a privately-held company located in Chapel Hill, North Carolina, has completed a successful pre-IND ("Investigational New Drug Application") meeting with the U.S. Food and Drug Administration ("FDA") regarding its plan to conduct clinical trials to establish the safety and effectiveness of its patented, topical painkilling drug, ELS115, containing NexACT® technology licensed from Apricus Bio.

Specifically, the meeting was a successful milestone in Exodos' effort to file an IND with the FDA for a topical, non-steroidal, anti-inflammatory drug ("NSAID"), combining the existing drug, ketoprofen, with Apricus Bio's NexACT® technology. The NexACT® technology is designed to permit drugs to be delivered through the skin with enhanced absorption and bioavailability.

Exodos licensed Apricus Bio's NexACT® technology for the topical delivery of drugs to treat pain and inflammation. "We are very encouraged by the progress achieved thus far by Exodos, for its topical NSAID product, which the company currently expects to be ready for IND filing by mid-2012," said Bassam Damaj, Ph.D., President and Chief Executive Officer of Apricus Bio. "The out-licensing of our NexACT® technology has allowed Exodos to move more quickly toward its clinical goals for its first product in this important disease area."

Apricus Bio noted that Exodos is expected to be the first NexACT® technology out-licensing partner to file for approval to initiate a human clinical program.

About the Exodos NSAI Drug ELS115

NSAIDs, such as ibuprofen and ketoprofen, have been in use for decades, successfully reducing pain and inflammation for millions of patients. However, while these drugs work well in pill form, there are many conditions for which the ability to target the drug in a localized manner, such as for treatment of arthritis in the hands, may be advantageous. To date, the challenge has been that these drugs exhibit poor skin penetration, making such efforts to deliver them locally, unsuccessful.

This challenge may be solved by Apricus Bio's NexACT® technology, which is intended to open up the tight junctions between skin cells. As a result, certain drugs attached to proprietary NexACT® chemicals may pass through the skin to reach their targets. Exodos' drug, ELS115, a combination of NexACT® technology and ketoprofen, may provide an effective and safe treatment of mild-to-moderate peripheral pain. If the clinical studies establish that the drug is safe and can be delivered through the skin right where it is needed, the product may be an important alternative for patients with localized pain and who may also: (i) have a history of gastrointestinal, kidney or liver problems which may be exacerbated by drugs taken in pill form, (ii) be geriatric or pediatric patients, and/or (iii) patients at risk for drug interactions, if the levels of circulating ketoprofen are very low to non-existent. Exodos selected ketoprofen as the active ingredient for its drug because ketoprofen has a decades-long record of safe clinical use.

About Exodos Life Science Partners

Exodos Life Sciences is a privately-held pharmaceutical development company that focuses on advancing new product concepts through the 505(b)(2) process to early clinical proof of principle, followed by asset (project) sale. Exodos has adopted a semi-virtual model to control costs and advance projects by utilizing its experienced team and on-call external pharmaceutical experts and partners.

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 existing 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 505(b)(2) New Drug Applications ("NDAs") or 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 and its partners such as Exodos Life Science Partners among others ability to further develop its and their products such as ELS115 for pain and other products and product candidates, to have its and their products and product candidates approved by relevant regulatory authorities, to successfully commercialize such products and product candidates and to achieve its and their 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.
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