DGAP-News: Apricus Biosciences Files for Orphan Drug Designation for RayVa(TM)

Apricus Biosciences, Inc.

13.04.2011 19:11
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Drug Intended for the Treatment of Raynaud–s Phenomena, Secondary to Systemic
Sclerosis

SAN DIEGO, 2011-04-13 19:11 CEST (GLOBE NEWSWIRE) —
Apricus Biosciences, Inc. (–Apricus Bio–) (Nasdaq:APRI) announced today its
filing with the U.S. Food&Drug Administration (–FDA–) requesting orphan drug
designation for RayVa?, the Company–s drug candidate indicated for the
treatment of Raynaud–s phenomenon in patients with systemic sclerosis.

Raynaud–s phenomenon is a condition in which the blood supply to fingers or
toes is suddenly reduced. With less blood, the skin turns pale or white, and
the fingers or toes become cold and numb.

The condition occurs in 4-15% of Americans, and is seven times more common in
women than men. In many cases, Raynaud–s phenomenon is caused by cold or
emotional distress, and is mostly an inconvenience. However, it also can be
caused by other diseases, such as systemic sclerosis, an autoimmune disorder.
Patients who develop Raynaud–s phenomenon as a consequence of systemic
sclerosis can have severe complications. For example, the skin, subcutaneous
tissues and muscles of the fingers and toes may weaken and shrivel, and in some
cases, the fingers can develop ulcers. In extreme cases, the ulcers lead to
gangrene, resulting in the loss of fingertips.

RayVa? is designed to treat the condition by increasing the blood flow to the
fingers and toes. One component of RayVa? is the already approved drug,
alprostadil, which has been clinically proven to boost blood flow. To create
RayVa?, alprostadil is combined with Apricus Bio–s clinically-validated,
proprietary NexACT(r) technology?a substance that temporary loosens the space
between cells, allowing drugs to penetrate the skin. RayVa? is designed to be
applied as a cream to fingers or toes, delivering alprostadil directly to the
area of need, in order to stimulate blood flow. Vitaros?, which also combines
alprostadil with the NexACT(r) technology, has already been approved in Canada to
treat erectile dysfunction.

–At Apricus Bio, we are continually expanding the potential uses for NexACT(r)
and other active drugs such as alprostadil, while also attempting to bring new
treatments to patients with unmet medical needs,– noted Bassam Damaj, Ph.D.,
Chairman, President and Chief Executive Officer of Apricus Bio. –Our orphan
drug filing for RayVa? is the second such orphan drug filing we have made in
the last several years and represents another milestone for the Company.– In
August 2008, the FDA granted orphan drug status for Apricus Bio–s proprietary
drug PrevOnco? for the treatment of liver cancer.

The FDA–s Orphan Drug Designation Program is designed to spur the development
of drugs to treat rare medical diseases. A company whose product is granted
orphan drug status receives, among other benefits, seven years exclusive
commercialization rights for the treatment of the disease and an expedited
review process.

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 control of the Company,
including, but not limited to, its ability to further develop products and
product candidates such as RayVa?, 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.
Investor Relations&Corporate Development, 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

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Language: English
Company: Apricus Biosciences, Inc.

United States
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ISIN: US9901429525
WKN:

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