DGAP-News: Apricus Biosciences Reports Reanalysis of Its U.S. Phase III Trials for MycoVa(TM) Showing Drug is Effective in Mycological Cure Resulting in Eradication of Nail Fungus

Apricus Biosciences, Inc.

27.06.2011 16:17
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Company to Revisit Its Regulatory Strategy for Potential U.S. and Canadian NDA
and NDS Submissions for MycoVa(TM)

SAN DIEGO, 2011-06-27 16:17 CEST (GLOBE NEWSWIRE) —
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(tm) 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(tm), 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(tm) 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(tm) over a
period of 48 weeks compared to those receiving placebo extending through to a
week 52 follow-up. MycoVa(tm) combines terbinafine — an existing, approved drug
for nail fungus — with Apricus Bio–s NexACT(r) 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(tm) is as effective for the
treatment of nail fungus as the current European standard of care for topical
therapy, Loceryl(r) (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(tm), 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(r) 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(tm) is that it is easy to apply, thus
improving patient compliance. MycoVa(tm) is applied to the infected nails,
typically at bedtime, with minimal preparation, such assimply 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(r) 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(r),
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(tm) 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.

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

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

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Language: English
Company: Apricus Biosciences, Inc.

United States
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ISIN: US9901429525
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