DGAP-News: Apricus Biosciences– Marketing Application for Vitaros(R), for the Treatment of Erectile Dysfunction, is Accepted for Review in Europe

Apricus Biosciences, Inc.

28.06.2011 16:47
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SAN DIEGO, 2011-06-28 16:47 CEST (GLOBE NEWSWIRE) —
Apricus Biosciences, Inc. (–Apricus Bio–) (Nasdaq:APRI) announced today that
its marketing application for Vitaros(r), indicated for the treatment of patients
with erectile dysfunction (–ED–), has been accepted for review through the
European Decentralized Procedure (–DCP–).

In connection with the DCP, on April 28, 2011, the Company filed its
application for marketing approval in multiple European countries, with the
Netherlands serving as its Reference Member State (–RMS–). The RMS evaluated
the application and has found it acceptable for review by the Company–s chosen
European Union countries for their individual consideration and approval. The
DCP process takes approximately 240 days from the time of acceptance for review
to final approval, and if approved, would give Apricus Bio the right to sell
Vitaros(r) as a treatment for ED in multiple chosen countries within the European
Union.

–We are very pleased that our marketing application for Vitaros(r) for ED has
been accepted for review, as it speaks to the quality of the trials and
clinical responses and is consistent with the guidance we received prior to
filing,– said Bassam Damaj, Ph.D., Chairman, President and Chief Executive
Officer of Apricus. –We look forward to working with the European regulatory
authorities in order to make Vitaros(r) available in Europe. In tandem, we are in
the process of preparing a submission for Vitaros(r) for ED in Switzerland, in
the near future. In addition, we are actively working with our current partner
in Italy and with other potential European partners on the commercialization of
the product in this region.–

Vitaros(r) is approved in Canada for the treatment of ED. The Company–s current
plan is for commercial launch of the product in that country during the second
half of 2011.

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: withthe 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 development products and
product candidates, to have its products and product candidates approved by
relevant European and other regulatory authorities, to successfully
commercialize such products and product candidates in Europe and other markets
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

28.06.2011 Dissemination of a Corporate News, transmitted by DGAP –
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The issuer is solely responsible for the content of this announcement.

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Language: English
Company: Apricus Biosciences, Inc.

United States
Phone:
Fax:
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Internet:
ISIN: US9901429525
WKN:

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