DGAP-News: Apricus Biosciences Announces Allowance of Israeli Patent, Expanding Its Patent Portfolio for the Topical Treatment of Premature Ejaculation

Apricus Biosciences, Inc.

17.01.2012 16:03
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SAN DIEGO, 2012-01-17 16:03 CET (GLOBE NEWSWIRE) —
Apricus Biosciences, Inc. (–Apricus Bio– or the –Company–) (Nasdaq:APRI)
(http://www.apricusbio.com) announced today that the Israeli Patent Office
recently issued a Notice of Allowance to grant a patent for the Company–s
development of a topical cream utilizing vasoactive prostaglandin E to treat
premature ejaculation (–PE–). When issued, the patent, entitled, –Compositions
and Methods for the Treatment of Premature Ejaculation,– will provide Israeli
patent protection until March 2024. It is one in a series of issued patents and
pending applications that Apricus Bio owns in the male sexual dysfunction field
utilizing its proprietary NexACT(r) technology, which includes its Vitaros(r)
product to treat erectile dysfunction (–ED–), among others in research and
development.

Commenting on today–s news, Dr. Bassam Damaj, Chairman, President and Chief
Executive Officer of Apricus Bio, stated, –We are very pleased with the
allowance of this patent in Israel for the use of vasoactive prostaglandin E to
treat PE. This patent includes the same pharmaceutical composition as found in
Apricus Bio–s Vitaros(r) product for ED combined with a local anesthetic and
represents our tenth patent granted in that country on our NexACT(r) technology.
Our proprietary NexACT(r) technology has enabled the Company to pursue and enter
into partnerships for the development and commercialization of Vitaros(r) and
other NexACT(r) products. We look forward to expanding our PE patent portfolio
and to speaking with potential partners regarding the development and
commercialization of pharmaceutical products for the treatment of PE in key
countries throughout the world.–

Vitaros(r) has been approved by Health Canada for marketing and sales for
patients with ED and the Company has filed for marketing approval for the drug
for this indication in the European Union and Switzerland. Vitaros(r) is a
topical cream that incorporates alprostadil, a well-recognized vasodilator
currently marketed by other companies as an injectable product or an
intra-urethral insert. The drug has been studied in over 3,300 patients,
including difficult to treat populations, such as those with diabetes, cardiac
problems, sildenafil (Viagra(r)) failures and post prostatectomy patients.
Vitaros(r) has demonstrated clinical efficacy and an excellent safety profile
versus the currently approved oral therapies, and is not contraindicated for
patients taking alpha blockers or nitrate medication. Viagra(r) is a registered
trademark of Pfizer, Inc.

Apricus Bio is currently studying the use of vasoactive prostaglandin E,
combined with and without local anesthetics, to develop a topical cream to
treat PE. To date, the Company has completed three clinical studies for this
application, including two single-blind studies and one double-blind study.

The Company–s PE patent portfolio currently consists of five issued patents
(Australia, Singapore, Japan, Korea and soon-to-be Israel) and seven pending
applications (the U.S., Canada, Europe, Mexico, Brazil, China and Hong Kong).

According to Datamonitor 2010, –Premature ejaculation is a commonly yet poorly
understood and defined male condition. Prevalence estimates vary greatly from
4% to 29% as stated by a study done by Simons and Carey (2001), according to
the different definitions used. The disorder is currently severely undertreated
and off-label prescription of selective serontonin reuptake inhibitors
(–SSRIs–) is the most common treatment pathway in the seven major markets.–

About Apricus Biosciences, Inc.

Apricus Bio is a San Diego-based, revenue-generating, specialty pharmaceutical
company, with commercial products and a broad pipeline across numerous
therapeutic classes.

Revenues and growth are driven from the sales of the Company–s commercial
products through its Apricus Pharmaceuticals USA, Inc. and NexMed (USA), Inc.
subsidiaries and through out-licensing in certain territories of its product
pipeline and NexACT(r) technology. Apricus Bio–s current pipeline includes
Vitaros(r), approved in Canada for the treatment of erectile dysfunction, Totect(r)
the only drug approved in the US for the treatment of anthracycline
extravasation, as well as compounds in development from pre-clinical through
pre-registration currently focused on Sexual Dysfunction, Oncology,
Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Consumer
Healthcare.

The Company also expects to develop and/or acquire and then bring to market
additional pharmaceutical products in areas of care that will benefit patient
needs worldwide.

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 ability to further develop its and their
products and product candidates, to have its products and product candidates
approved by relevant regulatory authorities, including Israel, to successfully
commercialize such NexACT(r) products and product candidates and to achieve its
development, commercialization and financial goals in Israel and other
countries. 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 Bio Contacts:
Ed Cox, V.P. Investor Relations&Corporate Development
Apricus Biosciences
(858) 848-4249
ecox@apricusbio.com

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

17.01.2012 Dissemination of a Corporate News, transmitted by DGAP –
a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.

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Language: English
Company: Apricus Biosciences, Inc.

United States
Phone:
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E-mail:
Internet:
ISIN: US9901429525
WKN:

End of AnnouncementDGAP News-Service

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