Apricus Biosciences, Inc.
14.11.2011 15:47
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SAN DIEGO, 2011-11-14 15:47 CET (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus Bio' or the 'Company') (Nasdaq:APRI)
announced today the acceptance of an abstract entitled, 'Age Group Analysis of
a Randomized, Double-blind, Phase 3 study of Femprox(r), a Topical Alprostadil
Cream with a Novel Transdermal Delivery Technology (Nexact(r)) for the Treatment
of Female Sexual Arousal Disorder ('FSAD'),' as a Highlighted Poster, followed
by an oral presentation at the upcoming European Society of Sexual Medicine
('ESSM') conference taking place in Milan, Italy, December 1-4, 2011.
Dr. Ignacio Moncada will present the poster with a short oral presentation and
question and answer session on Friday December 2, 2011, during the Women's
Sexual Health Session (HP-03-008), scheduled to take place from 3:00 pm to 3:30
pm CET in Exhibition Hall B Area 1. Dr. Moncada is President of the Spanish
Association of Sexual Health and a member of the Guidelines Committee for
Sexual Dysfunctions of the European Association of Urology. He is also the
author of numerous chapters in related reference books and a member of the
Company's Sexual Dysfunction Clinical Advisory Board.
The poster presentation will discuss an age group analysis of primary and
secondary endpoints of the completed 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. 'The efficacy and safety of our Femprox(r) drug candidate
is
increasingly being recognized by the clinical community worldwide; the
endorsement of the leaders of the heads of the sexual societies worldwide is a
testimony of the superiority and the potential of our drug,' said Dr. Bassam
Damaj, President and Chief Executive Officer of Apricus Bio.
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, 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.
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 and their
products such as Femprox(r) for Female Sexual Arousal Disorder 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.
CONTACT: Apricus Biosciences, Inc.Edward Cox, V.P.Investor Relations &
Corporate DevelopmentApricus Bio, Inc.(858) 848-4249ecox@apricusbio.comApricus
Bio Investor RelationsPaula SchwartzRx Communications Group, LLC(917)
322-2216pschwartz@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:
End of Announcement DGAP News-Service
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DGAP-News: Femprox(R) Phase III Clinical Data From Apricus Biosciences Chosen for a Presentation at the European Society for Sexual Medicine
| Source: EQS Group AG