DGAP-News: Apricus Biosciences Press Release

Apricus Biosciences, Inc.

15.12.2011 16:18
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Apricus Biosciences Announces Oral Presentation of Efficacy and Clinical Safety
Data for Vitaros(R) and Femprox(R) at the African Society for Sexual Medicine
Conference

SAN DIEGO, 2011-12-15 16:11 CET (GLOBE NEWSWIRE) — Apricus Biosciences, Inc.
(–Apricus Bio– or the –Company–) (Nasdaq:APRI) announced today the planned,
oral presentation of clinical efficacy and safety data for both of its lead
products in sexual medicine — Vitaros(r) for erectile dysfunction (–ED–) and
Femprox(r) for Female Sexual Arousal Disorder (–FSAD–) — at the Biennial
Meeting of the African Society for Sexual Medicine (–ASSM–), taking place in
Dakar, Senegal, from December 15 to December 17, 2011.

Specifically, Dr. Jacques Buvat, a member of the Company–s Sexual Dysfunction
Clinical Advisory Board, will present the overall combined dataset from two
pivotal Phase III clinical trials in 1,732 patients suffering from ED, with
special focus and sub-analyses in patients with hypertension, cardiovascular
disease and diabetes. In the State of the Art lecture session, –Female Sexual
Dysfunction Update,– Dr. Buvat will also discuss an age group analysis of
primary and secondary endpoints of a Phase III clinical trial to provide
further evidence of the statistically significant efficacy and safety profile
of Apricus– investigational drug, Femprox(r) (topical alprostadil cream 0.4 %) in
this clinical trial.

–We are very pleased with the warm reception Dr. Buvat and other presenters of
our Vitaros(r) and Femprox(r) products have been experiencing at recent sexual
medicine conferences throughout the world,– said Dr. Bassam Damaj, Chairman,
President and Chief Executive Officer of Apricus Bio. –As we announced last
week, Dr. Buvat–s presentation on Vitaros(r) was named the Best Clinical
Presentation 2011 (Male Sexual Disorder (–MSD) by the Scientific Committee of
the Congress for the European Society of Sexual Medicine (–ESSM–), which
recently took place in Milan, Italy from December 1-4, 2011. We are very happy
that experts in the field of sexual medicine are recognizing the important
impact that we believe Vitaros(r) and Femprox(r) can make in this field.–

Dr. Damaj continued, –We are very excited about discussing these products with
leading experts in Africa at the conference and in other meetings in that
region. In addition, as we continue to work towards closing our fourth
worldwide partnership for Vitaros(r) for ED as planned in Canada in 2011, we look
forward to our continued discussions with potential partners in these African
countries.–

About Vitaros(r) and the ED Market

The current leading drugs for erectile dysfunction 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 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, which the
Company believes is much faster than the results from the currently marketed
oral treatments.

Alprostadil is currently marketed as an injectable drug or as a suppository
inserted into the urethra. The key innovation behind Vitaros(r) is 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.

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 Femprox(r)

Femprox(r) is an alprostadil-based cream intended for the treatment of FSAD.
Apricus Bio has completed nine clinical studies to date, including one,
98-patient Phase II study in the U.S. and a 400-patient Phase III study in
China.

It is the Company–s understanding that no product is currently approved for
FSAD in the U.S., a persistent or recurring inability to attain, or maintain
adequate sexual excitement, causing personal distress.

Femprox(r) exerts a local, relaxant effect on vulvar and clitoral blood vessels
in women, leading to increased blood flow. The resultant increase in
lubrication and sensory feedback is believed to produce a clinically
significant increase in sexual arousal in women with FSAD.

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, 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 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

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, can 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 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 products such
as Vitaros(r) for erectile dysfunction and other 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 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.
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

15.12.2011 Dissemination of a Corporate News, transmitted by DGAP –
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Language: English
Company: Apricus Biosciences, Inc.

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

End of Announcement DGAP News-Service

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