Apricus Biosciences, Inc.
12.12.2011 18:16
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Apricus Biosciences' Vitaros(R) Podium Presentation Named Best Clinical
Presentation 2011 (Male Sexual Disorder) by the Scientific Committee of the
Congress for the European Society of Sexual Medicine Meeting in Milan
SAN DIEGO, 2011-12-12 18:03 CET (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc.
('Apricus Bio' or the 'Company') (Nasdaq:APRI) announced today that its podium
presentation by Dr. Jacques Buvat on Vitaros(r), entitled, 'Efficacy and Safety
of Topical Alprostadil Cream (Vitaros(r)) in Hypertensive, Diabetic and Cardiac
Patients with Male Erectile Dysfunction,' 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') that recently
took place in Milan, Italy on December 1-4, 2011. The list of Best Clinical
Presentation 2011 awards (MSD) can be viewed online at
http://www.essm-congress.org/essm-awards.html.
'We are very pleased that the number one sexual medicine society in Europe has
recognized the top quality of our Vitaros(r) product for erectile dysfunction,'
said Dr. Bassam Damaj, Chairman, President and Chief Executive Officer of
Apricus Bio. 'Like the ESSM, we are very excited about the potential that
Vitaros(r) can bring to the treatment of this male sexual problem and we are
very
pleased that a well-known, worldwide expert, Dr. Buvat, has been one of our
biggest advocates in Europe. Since our product competed with oral drugs of
other companies to treat this condition, we are very encouraged that our
topical treatment could be very competitive in this lucrative field. We are
presently working with the relevant European regulatory authorities and our
current and potential European partners to bring this important drug to the
market.'
Dr. Buvat's presentation, which was one of 18 podium presentations at the ESSM
event in the MSD category, discussed the overall combined dataset from two
pivotal Phase III clinical trials in 1,732 patients suffering from erectile
dysfunction ('ED') with special focus on integrated sub-analyses of these
trials in patients with hypertension, cardiovascular disease and diabetes.
Dr. Buvat was also presented with an additional Career Award at the ESSM event.
'We would like to congratulate Dr. Buvat on this prestigious career award and
we would like to thank him again for his advocacy for our product and for his
service on our Sexual Dysfunction Clinical Advisory Board,' said Dr. Damaj.
Apricus Bio received marketing approval for Vitaros(r) as a first-line treatment
for ED from Health Canada in November 2010 for sales of the product in that
country. In April 2011, the Company filed a marketing application in the
European Union, under the Decentralized Procedure ('DCP'), for Vitaros(r) for
the
treatment of ED, with the Netherlands as its Reference Member State. Under the
DCP, approval in a Reference Member State means that a drug may be sold in all
of the European Union countries that were filed with the DCP as Concerned
Member States. In July 2011, Apricus Bio filed for regulatory approval with
Swissmedic, the Swiss Agency for Therapeutic Products for marketing of
Vitaros(r)
in that country. Preparations for filing in certain Latin American countries
are ongoing.
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 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.
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
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ISIN: US9901429525
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