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Apricus Biosciences Reports Reanalysis of Its U.S. Phase III Trials for MycoVa Showing Drug is Effective in Mycological Cure Resulting in Eradication of Nail Fungus

Date : 06/27/2011 @ 10:17AM
Source : GlobeNewswire Inc.
Stock : Apricus Biosciences, Inc. (APRI)

http://ih.advfn.com/p.php?pid=nmona&article=48216865

Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq:APRI) announced today that, based on a successful and statistically significant reanalysis of its U.S. Phase III trials for its MycoVa™ product, originally intended for treating onychomycosis (nail fungus), it is revisiting its regulatory strategy for the drug. Specifically, a combined post-hoc analysis of two randomized, double-blind, vehicle controlled, multicenter, parallel group Phase III studies to assess the efficacy, safety and tolerability of MycoVa™, demonstrated statistically significant results in mycological cure, resulting in the eradication of nail fungus in favor of active treatment in patients who did not present with comorbid tinea pedis (athlete's foot), as these patients are considered at higher risk of reinfection.

Dr. Aditya Gupta, Medical Investigator at Mediprobe Research, who also acted as the Principal Investigator of one of the Phase III trials, was consulted to review the data with a view to the feasibility of reanalysis. The analysis investigated mycological cure as most relevant in terms of effectiveness, as this identifies if the drug is actually capable of treating the infectious process.

The reanalysis indicates that MycoVa™ is able, over an extended period of time, to kill the infecting fungus in 20% of patients with mild to moderate dermatophyte onychomycosis. Mycological cure is significantly greater in patients without comorbid tinea pedis who are treated with MycoVa™ over a period of 48 weeks compared to those receiving placebo extending through to a week 52 follow-up. MycoVa™ combines terbinafine -- an existing, approved drug for nail fungus -- with Apricus Bio's NexACT® technology, which enhances the absorption of the drug through the skin. In January 2011, Apricus Bio reported results of an additional analysis showing that MycoVa™ is as effective for the treatment of nail fungus as the current European standard of care for topical therapy, Loceryl® (an ointment made by Galderma). Those results convinced the Company to seek regulatory guidance meetings from certain health agencies in Europe.

"The previously reported non-inferiority analyses and the new data with stratification by comorbid athlete's foot will enable us to move forward with our plans to seek regulatory approval guidance for MycoVa™, and to potentially market the product as an antifungal nail treatment in Europe and North America," said Dr. Bassam Damaj, Chairman, President and Chief Executive Officer of Apricus Bio.

The Company currently holds 16 patents related to the treatment of nail fungus, with 13 patent applications pending, and has patent protection for its underlying NexACT® technology used in the nail fungus treatment in Europe, and well as in a number of other countries.

The advantage of Apricus Bio's MycoVa™ is that it is easy to apply, thus improving patient compliance. MycoVa™ is applied to the infected nails, typically at bedtime, with minimal preparation, such as simply washing with soap and water. The formulation allows significant amounts of the drug to penetrate through the nail plate to the nail bed and surrounding area where fungus is located without significant systemic exposure.

About Apricus Biosciences, Inc.

Apricus Bio, a San Diego based revenue-generating pharmaceutical 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 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.

For further information on Apricus Bio, visit http://www.apricusbio.com and for information on its subsidiaries please visit www.nexmedusa.com or www.bio-quant.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 are outside the control of the Company, including, but not limited to, its ability to further development MycoVa™ and other products and product candidates, have such products and product candidates approved by relevant regulatory authorities, to successfully commercialize such 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 Biosciences, Inc.
[phone]
[e-mail]

Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
[phone]
[e-mail]

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http://www.benzinga.com/news/11/06/1203036/apricus-biosciences-reports-reanalysis-of-its-u-s-phase-iii-trials-for-mycova-sho