DGAP-News: Apricus Biosciences, Inc. Press Release

Apricus Biosciences, Inc.

19.01.2011 17:41
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Apricus Biosciences Reports 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)

SAN DIEGO, Jan. 19, 2011 (GLOBE NEWSWIRE) — Apricus Biosciences, Inc.
(–Apricus Bio–) (Nasdaq:APRI) today announced that an additional analysis
conducted on behalf of the Company has shown that MycoVa? has successfully
demonstrated –non-inferiority– for the treatment of onychomycosis (commonly
referred to as nail fungus), compared to the current standard of care in Europe
for topical therapy, Loceryl(r).

–Non-inferiority– means that the experimental treatment worked well enough,
compared to the effective existing drug, to support the conclusion that the new
test drug is also effective. With this new analysis, Apricus Bio intends to
request regulatory guidance from certain European agencies for the continued
development of MycoVa? and hopes to eventually file for approval in certain
European countries to market the drug for onychomycosis. –We are very pleased
with this new analysis,– says Dr. Bassam Damaj, President and Chief Executive
Officer of Apricus Bio. –We believe it may allow us to move forward towards
eventual approval of the drug.–

MycoVa?(formally known as NM100060) combines an existing, approved drug for
nail fungus, terbinafine, with Apricus– NexACT(r) technology that enhances the
absorption of the drug through the skin. Clinical trials on the drug started
after 2005, when NexMed (now known as Apricus Bio) signed an agreement with
Novartis, under which Novartis assumed responsibility to develop and
commercialize the drug.

The first clinical trials did not show clear-cut efficacy, and in 2008, NexMed
announced that the results were not strong enough to support filing for new
drug approval with the U.S. Food&Drug Administration. Novartis declined to
continue to develop the drug in 2009, and NexMed acquired the worldwide rights
to the drug, subject to certain payments to be made to Novartis.

A later trial conducted by Novartis in Europe between 2007 and 2009, comparing
MycoVa? with Loceryl(r) over 48 weeks, was more promising. The reanalysis of the
comparator trial data announced today shows that MycoVa? is no less effective
than Loceryl(r)in curing nail fungus. The percentage of patients with an adverse
event that was suspected to be related to study drug was low for both drugs
with no serious adverse events attributed to the drugs. There also were no
safety concerns.

–We were disappointed that Novartis did not move forward with the drug in 2009,
but we were excited when we regained worldwide rights, subject to certain
payments to Novartis,– explained Dr. Damaj. –We were convinced at that time,
and remain so today, that MycoVa? had, and has, the potential to treat patients
with mild onychomycosis. The analysis that we have recently performed has
convinced us to move forward and request regulatory guidance meetings from
health agencies in the United Kingdom, the Netherlands and Germany.–

In the study, 1,029 patients with mild to moderate nail fungus were given
either MycoVa? (a topical 10% terbinafine hydrogen chloride formulation) or
Loceryl(r) (5% amorolfine nail lacquer) for 48 weeks of treatment. The primary
objective endpoint was a completecure. The secondary endpoints were killing
the fungus and improving the appearance of the nail.

The reanalysis of the results showed no significant difference in either the
primary or secondary endpoints between MycoVa? and Loceryl(r),which is a
registered trademark of Galderma.

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. By contrast, Loceryl(r) requires more patient care before
applying the lacquer. For Loceryl(r), this includes filing the affected areas of
nail, including the nail surfaces, as thoroughly as possible. The surface of
the nail should then be cleansed using disposable swabs. The nail lacquer
should be applied onto the entire surface of the infected nail(s) using
reusable applicators. Before repeat application of Loceryl(r), the affected
nails should be filed down again as required, following cleansing with a
cleaning pad to remove any residual lacquer.

Onychomycosis is a chronic persistent fungal infection of the nail bed
resulting in thickening and discoloration of the nail, which sometimes can be
accompanied by serious pain and disability. According to the Merck Manual, the
worldwide incidence rate of onychomycosis is approximately 10%. As described by
Iorizzo and Piraccini (2007), the incidence has been increasing due to
diabetes, immunosuppression and an aging population. While occurring in
approximately 2.6% of children younger than 18 years, it occurs in as much as
90% of the elderly population (eMedicine.medscape.com). As of 2008, Thomson
Reuters Pharma has stated that the worldwide market is approximately $2.8
billion in size and is expected to grow to approximately $2.9 billion by 2014.

About Apricus Biosciences, Inc.

Backed by NexMed, USA and Bio-Quant, Inc., its revenue generating CRO business,
Apricus Bio 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. Future growth is
expected to be driven primarily through out-licensing of this technology for
the development and commercialization of such compounds to pharmaceutical and
biotechnology companies, worldwide. Concurrently, the Company is seeking to
monetize its existing product pipeline, including its approved drug erectile
dysfunction treatment, Vitaros(r), as well as compounds in development from
pre-clinical through Phase 3, currently focused on dermatology, sexual
dysfunction and cancer. For further information on Apricus Bio and its
subsidiaries, visit http://www.apricusbio.com.

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 obtain and/or enforce patent
coverage in major markets, to develop products that have been demonstrated in
clinical trials and to successfully enter into partnership agreements for its
product candidates, its Vitaros(r) product and its NexACT(r) platform technology.
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–swebsite or without charge
from the Company.

CONTACT: Apricus Biosciences, Inc.
Edward Cox
VP, Investor Relations& Corporate Development
(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
Phone:
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ISIN: US9901429525
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