Apricus Announces National Phase Approval for Erectile Dysfunction Cream - Vitaros(R) in France
Vitaros(R) Remains on Track for European Launch in 2014
SAN DIEGO, Dec. 19, 2013 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc.
("Apricus" or the "Company") (Nasdaq:APRI) (www.apricusbio.com), today announced
that France's National Agency for Medicines and Health Products Safety (ANSM)
has granted national phase approval to Vitaros(®), indicated for the treatment
of patients with erectile dysfunction ("ED"). The Company has now received a
total of seven national phase approvals for Vitaros(®), including France,
Germany, Ireland, Italy, the Netherlands, Sweden and the United Kingdom (the
"UK") following its broad approval by European health authorities in June 2013.
"The approval of the Vitaros(®) marketing authorization in France marks a
significant milestone for Apricus and Laboratories Majorelle, our
commercialization partner in France. We will continue to support Majorelle as
they prepare for a successful launch of the first topical, on-demand treatment
for ED in one of the largest ED markets in Europe," said Richard Pascoe, Chief
Executive Officer of Apricus. Â "Majorelle's depth and experience in the French
urology market gives us great confidence that Vitaros(®) will achieve long term
commercial success in France as a treatment of choice for men suffering from
ED."
In June 2013, Apricus announced that its marketing application for Vitaros(®)
was approved through the European Decentralized Procedure ("DCP"). Under the
DCP, Apricus filed its application for marketing approval designating the
Netherlands as the Reference Member State ("RMS") on behalf of nine other
European Concerned Member States ("CMS") participating in the procedure. The
Company continues to work toward obtaining country-by-country national phase
approvals in the remaining CMS territories including Belgium, Spain and
Luxembourg. Once the national phase approvals are secured on a country-by-
country basis, marketing of Vitaros(®) can then be initiated in each country by
Apricus' commercialization partners.
Vitaros(®) is expected to become the first new and novel ED product launched in
nearly a decade, and with its unique product profile that addresses a large
number of patients who cannot or do not respond well to the existing therapies,
or who are intolerant to the systemic effects of PDE-5 inhibitors, is well-
positioned for commercial success. In Europe alone, the existing ED products
generated over $1 billion in sales in 2012. Apricus believes that a significant
portion of the market remains untreated or under-treated, which represents a
substantial commercial opportunity for Vitaros(®).
Vitaros(®) is currently partnered in key markets, including with Takeda in the
UK, Sandoz in Germany, Switzerland and Northern Europe, Bracco in Italy,
Majorelle in France, Monaco and certain African countries, and Abbott in Canada.
 The Company's existing commercialization partners are preparing for Vitaros(®)
product launches throughout 2014 in their respective territories.
About Vitaros(®)
Vitaros(®) has been approved for the treatment of ED by the European health
authorities and by Health Canada. Vitaros(®) is a topically-applied cream
formulation of alprostadil, a vasodilator, combined with our proprietary
permeation enhancer DDAIP.HCl, which directly increases blood flow to the penis,
causing an erection. Â Alprostadil is a widely accepted alternative to the PDE-5
inhibitors for difficult to treat patients, and Vitaros(®), which was determined
to be safe and effective by the European health authorities and previously by
Health Canada, offers greater market opportunity due to its patient-friendly
form versus other alprostadil dosage forms and also relative to oral ED
products. Â With nearly 150 million men worldwide who suffer from ED and an ED
market size of approximately $1 billion in revenue in Europe alone, Vitaros(®)
represents a major market opportunity for Apricus and its commercial partners
given its unique product profile and its potential to treat a large underserved
population.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI) is a pharmaceutical company that develops and
markets through its licensing partners innovative treatments that have the
potential to help large patient populations across numerous, large-market
therapeutic classes including male and female sexual health. Â The Company has
one approved product, Vitaros(®), for the treatment of erectile dysfunction,
which is now approved in Europe and Canada and will be commercialized by
Apricus' marketing partners, which include Abbott Laboratories Limited, Takeda
Pharmaceuticals International GmbH, Hexal AG (Sandoz), Bracco SpA and
Laboratoires Majorelle.  Femprox(®), the Company's product candidate for the
treatment of female sexual interest/arousal disorder, has successfully completed
a nearly 400-subject proof-of-concept study.
For further information on Apricus, visit http://www.apricusbio.com.
Apricus' 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 product
Vitaros(®) for ED, such as the room temperature version of Vitaros(®) and
product candidate Femprox(®) for female sexual interest/arousal disorder among
others; to have its product and product candidates receive additional patent
protection and be approved by relevant regulatory authorities in Europe, the
United States, Canada and in other countries, such as additional national phase
approvals for Vitaros(®) in the remaining CMS territories, including Belgium,
Spain and Luxembourg; to successfully commercialize such product and product
candidates and other NexACT(®) product candidates and drug delivery technology;
and to achieve its other development, commercialization and financial goals,
such as successfully manufacturing and launching Vitaros(®) in partnered
territories, including France. 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, as amended, subsequent quarterly reports filed on Form 10-Q, as amended,
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 Investor Relations:
David Pitts or Lourdes Catala
Argot Partners
212-600-1902
david@argotpartners.com
lourdes@argotpartners.com
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Source: Apricus Biosciences, Inc. via GlobeNewswire
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