DGAP-News: Apricus Biosciences Requests Approval of Vitaros(R) as a Treatment for Erectile Dysfunction in Europe

Apricus Biosciences, Inc.

28.04.2011 16:06
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Current Annual Market for Erectile Dysfunction in Europe is Estimated at
Approximately $1.1 Billion

SAN DIEGO, 2011-04-28 16:06 CEST (GLOBE NEWSWIRE) —
Apricus Biosciences, Inc. (–Apricus Bio–) (Nasdaq:APRI) announced today that it
has filed a marketing application in Europe for Vitaros(r) as a treatment for
patients with erectile dysfunction (–ED–). Approval of the application would
give Apricus the right to sell Vitaros(r) in multiple chosen countries in the
European Union. –Our goal is to help millions of patients suffering with
erectile dysfunction in Europe,– said Bassam Damaj, Ph.D., Chairman, President
and Chief Executive Officer of Apricus Bio.

Vitaros(r) has already been approved in Canada for the treatment of erectile
dysfunction. Warner Chilcott, which owns the U.S. rights to Vitaros(r) for ED,
has submitted a New Drug Application to the U.S. Food and Drug Administration,
requesting approval in the U.S.

Before submitting the European application, Apricus Bio consulted with
regulators in the United Kingdom, Germany and the Netherlands, and received
positive guidance from each. The application includes positive data from the
Company–s two Phase III clinical studies of Vitaros(r) as a treatment for ED, as
well as information about the chemistry, manufacturing and controls (–CMC–) for
the drug.

Under a European system called the –Decentralized Procedure– (DCP), a company
files its application for marketing approval of a drug in just one European
country, which is designated the Reference Member State (RMS). Apricus Bio has
chosen The Netherlands as its RMS. The RMS then evaluates the application and
prepares an assessment report that is submitted to other chosen European Union
countries for their consideration and approval. The entire process takes
approximately 240 days. One of the major advantages of the DCP is that a
company may receive identical marketing authorizations for its product in
multiple chosen European Member countries at the same time.

–This submission is another major milestone for the Company,– said Damaj. –We
look forward to working with the European regulatory authorities as they review
our application.–

About Vitaros(r) and the ED Market

According to IMS Health data, the annual ED market in Europe in 2010 was about
$1.2 billion. The current leading drugs are Viagra(r), Cialis(r) and Levitra(r),
which are taken in pill form and work by inhibiting an enzyme called PDE5.

There is still a need for new, safe and effective treatments, however,
especially for those patients who cannot or do not respond well to oral
medication. Vitaros(r) differs from Viagra(r), Cialis(r) and Levitra(r) in two ways.
Instead of being a pill, Vitaros(r) is applied directly to the penis as a cream.
The topical application helps to reduce side effects and offers men who do not
do well with the existing drugs a patient-friendly alternative.

Second, Vitaros(r) operates by a different biochemical mechanism than oral ED
medications. It contains a previously marketed ED drug known by the chemical
name of alprostadil. When absorbed through the skin, alprostadil directly
boosts blood flow, thereby causing an erection within minutes — much faster
than the results achieved from the oral treatments.

Alprostadil is currently marketed as an injectable drug or as a suppository
inserted into the urethra. The key innovation behind Vitaros(r) was combining
alprostadil with Apricus Bio–s NexACT(r) delivery technology, which allows the
drug to pass through the skin and makes the treatment much easier to apply.

In clinical studies, Vitaros(r) worked in patients suffering from mild to severe
ED, including men who did not respond to Viagra. The side effects reported were
localized and transient. –We believe that Vitaros(r) will be an attractive
alternative to the oral PDE5 inhibitors for many patients with erectile
dysfunction,– noted Damaj.

Viagra(r) is a registered trademark of Pfizer, Inc.; Cialis(r) is a registered
trademark of Lilly, USA; Levitra(r), is a registered trademark of Bayer A.G.; and
Vitaros(r) is a registered trademark in Canada held by Apricus Bio, and in the
U.S. held by Warner Chilcott Company.

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 development products and
product candidates, to have its products and product candidates approved by
relevant regulatory authorities, 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
Phone:
Fax:
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Internet:
ISIN: US9901429525
WKN:

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