Apricus Biosciences Announces Poster Presentation of Vitaros(R) Data in Men
Previously Unresponsive to PDE-5 Inhibitors at American Urological Association
SAN DIEGO, May 7, 2013 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus
Bio" or the "Company") (Nasdaq:APRI) (www.apricusbio.com) announced today that
John P. Mulhall, MD, Director of the Male Sexual and Reproductive Medicine
Program at Memorial Sloan-Kettering Cancer Center, will present results from
an analysis of existing Phase 3 data for Vitaros®, the Company's lead product
candidate for the treatment of erectile dysfunction (ED), at the American
Urological Association Annual Meeting which is taking place May 4-8, 2013 in
San Diego, CA.
The abstract titled, "Vitaros^® Efficacy and Safety in Viagra^® Non-Responders
with Longer Term Use," will be presented as a moderated poster (#1519) during
a session titled "Sexual Function/Dysfunction/Andrology: Medical and
Non-Surgical Therapy," taking place Tuesday, May 7, 2013 from 8-10 a.m. local
time. Dr. Mulhall will give a short oral presentation, which will then be
followed by a question and answer period.
This analysis evaluated the safety and efficacy of Vitaros^® after 12 weeks,
and longer term use, in men previously unresponsive to phosphodiesterase type
5 (PDE-5) inhibitors, such as Viagra^® (n=325). Results showed that 200mcg and
300mcg doses of Vitaros® improved erections in this population and adverse
events (AE) were mild to moderate, similar to those seen in the control group,
and decreased with repeated exposure.
"PDE-5 inhibitors, while effective, address only a portion of the ED patient
population. In the current treatment landscape, this leaves a large population
of unresponsive or contraindicated patients with few or no alternatives," said
Dr. John Mulhall, lead author and Director of the Male Sexual and Reproductive
Medicine Program at Memorial Sloan-Kettering Cancer Center. "Vitaros^®
utilizes a novel mechanism of action that has demonstrated successful ED
therapy without the side effects associated with current products, making it
an effective and practical option for these patients."
Dr. Mulhall is also an Associate Editor for the Journal of Sexual Medicine and
past President of the Sexual Medicine Society of North America.
Vitaros^®, Apricus Bio's lead product candidate for the treatment of ED, is a
topically-applied cream formulation of alprostadil, a vasodilator, which
directly increases blood flow to the penis, causing an erection. Vitaros is
approved in Canada and Apricus Bio has filed for regulatory approval in
Europe.Alprostadil is a widely accepted alternative to the PDE5 inhibitors
for difficult to treat patients, and Vitaros^® is relatively safe and
effective, and offers greater market opportunity due to its patient-friendly
form versus both other alprostadil dosage forms and also relative to oral ED
products.With a market affecting nearly 150 million men worldwide and
representing approximately $2.6 billion in revenue – excluding the U.S. –
Vitaros^® represents a major market opportunity, particularly as a distinct
product that addresses a significant underserved population.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (Nasdaq:APRI) is a pharmaceutical company that
develops and markets innovative treatments that help large patient populations
across numerous, large-market therapeutic classes including male and female
sexual health. The Company has one approved product, Vitaros^®, for the
treatment of erectile dysfunction, which will be marketed in Canada by Abbott
Laboratories, and Femprox^®, a product candidate, for the treatment of female
sexual arousal disorder, which successfully completed one approximately
400-patient Phase III study in China.
For further information on Apricus Bio, visit http://www.apricusbio.com.You
can also receive information at http://twitter.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 achieve its
development, commercialization and financial goals, its ability to further
develop its products and product candidates including Vitaros® for erectile
dysfunction and to have this product be effective in men who have previously
tried PDE-5 inhibitors, the timing for a commercial launch of Vitaros^® in any
country, and its ability to have its products and product candidates approved
by relevant regulatory authorities, and its ability to receive appropriate
regulatory guidance on Femprox^® from various regulatory authorities, to
successfully conduct further clinical trials with this product and its ability
to eventually commercialize Femprox^®. 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: David Pitts or Lourdes Catala
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