DGAP-News: Apricus Biosciences Announces Korean Patent Approval for MycoVa(TM) for Nail Fungus

Apricus Biosciences, Inc.

03.10.2011 17:03
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CEO Foresees Expanded Asian Patent Coverage for MycoVa(TM) Product

SAN DIEGO, 2011-10-03 17:03 CEST (GLOBE NEWSWIRE) —
Apricus Biosciences, Inc. (–Apricus Bio– or the –Company–) (Nasdaq:APRI)
(http://www.apricusbio.com) announced today that the Korean Patent Office will
grant a patent for MycoVa(tm), indicated for the treatment of onychomycosis
(commonly referred to as nail fungus).

Specifically, the Korean Patent Office recently issued a –notice of allowance–
for the Company–s patent application, entitled, –Antifungal Nail Coat and
Method of Use.– Once issued, this will represent the fifth patent that Apricus
Bio has received in Asia for MycoVa(tm) for onychomycosis, and the first in South
Korea for this product. The patent will provide the Company with patent
protection for MycoVa(tm) and its use for nail fungus in South Korea until March
2024.

–We are excited about the further expansion of our MycoVa(tm) patent portfolio in
South Korea and Asia,– said Dr. Bassam Damaj, Chairman, President and Chief
Executive Officer of Apricus Bio. –Our prior patent expansion for MycoVa(tm) in
the U.S. and Europe, combined with a reanalysis of the data from an earlier
Phase III study on MycoVa(tm), has led us to seek guidance from the regulatory
authorities in the U.S. and Europe to file for marketing approval in those
countries. We look forward to eventually expanding these regulatory filings
internationally to certain other countries, such as those in Asia, in which we
currently plan to develop future commercial partnerships.–

Apricus Bio currently holds 17 patents related to the treatment of nail fungus,
with 12 patent applications pending, and has patent protection for its
underlying NexACT(r) technology used in the nail fungus treatment in South Korea,
Asia, as well as in a number of other countries and regions.

About MycoVa(tm)

MycoVa(tm) combines an existing, approved drug for nail fungus, terbinafine, with
the NexACT(r) technology that enhances the absorption of the drug through the
skin. In January 2011, the Company announced that an additional analysis showed
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).

In June 2011, the Company announced that based on a reanalysis of its Phase III
trials for its MycoVa(tm) product for treating onychomycosis (nail fungus), it is
revisiting its regulatory strategy for the drug and will seek guidance from
regulatory authorities in the U.S. and Europe. 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 primary and secondary
efficacy endpoints 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.

The advantage of Apricus Bio–s MycoVa(tm) product is that it is easy to apply, and
is therefore expected to improve patient compliance. MycoVa(tm) 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.

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.

Apricus Bio, a San Diego-based, revenue-generating, biopharmaceutical 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 Rx Division 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.

The Company is also developing its Consumer Healthcare Division by developing a
number of drugs that utilize the Company–s NexACT(r) technology to comply with
the FDA–s over-the-counter (–OTC–) requirements, 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 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 receive issued patents on its
NexACT(r) technology and products, develop such patented technology into product
candidates in South Korea, other parts of Asia and in other countries, have its
Rx Division products and product candidates such as MycoVa(tm) approved by
relevant regulatory U.S., European, South Korean and other Asian country
authorities and its Consumer Healthcare Division products either approved or
cleared by relevant regulatory authorities or be in compliance with appropriate
regulatory requirements, to successfully manufacture and commercialize such Rx
Division products in the U.S., Europe, South Korea and other Asian countries
along with its Consumer Healthcare Division 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 Bio, 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

03.10.2011 Dissemination of a Corporate News, transmitted by DGAP –
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Language: English
Company: Apricus Biosciences, Inc.

United States
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ISIN: US9901429525
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End of Announcement DGAP News-Service

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