DGAP-News: Apricus Biosciences, Inc. /
Apricus Biosciences Announces National Phase Approval for Erectile
Dysfunction Cream - Vitaros(R) in Belgium
23.01.2014 / 16:07
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Vitaros(R) Remains on Track for Launch in 2014
SAN DIEGO, 2014-01-23 16:07 CET (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus' or the 'Company') (Nasdaq:APRI)
(www.apricusbio.com), today announced that Belgium's Ministry of Social
Affairs, Public Health and Environment has granted national phase approval to
Vitaros(r), indicated for the treatment of patients with erectile dysfunction
('ED'). The Company has now received a total of eight national phase approvals
for Vitaros(r), including Belgium, France, Germany, Ireland, Italy, the
Netherlands, Sweden and the United Kingdom ('UK') following its broad approval
by European health authorities in June 2013. Apricus has an exclusive
commercialization partnership in place with Hexal AG, an affiliate within the
Sandoz Division of the Novartis Group of Companies ('Sandoz'), for the
commercialization of Vitaros(r) in several European countries, including
Belgium.
'We are pleased to be working with our partner Sandoz as they make progress
towards preparing Vitaros(r) for commercial launch in their licensed territories
including Belgium,' said Richard Pascoe, Chief Executive Officer of Apricus.
'We remain excited about the opportunity for all of our existing partners to
bring the first and only on-demand, topical erectile dysfunction treatment to
the market this year.'
In June 2013, Apricus announced that its marketing application for Vitaros(r)
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 the remaining national phase
approvals in Spain and Luxembourg.
Once launched, Vitaros(r) will become the first new and novel ED product 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, it 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(r).
Vitaros(r) is currently partnered in key markets, including with Takeda in the
UK, Sandoz in Germany, Switzerland and certain countries in 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(r) product launches in their respective territories with
product launches expected throughout 2014.
About Vitaros(r)
Vitaros(r) has been approved for the treatment of ED by the European health
authorities and by Health Canada. Vitaros(r) 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. Alprostadil is a widely accepted alternative to the
PDE-5 inhibitors for difficult to treat patients, and Vitaros(r), 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. 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(r) 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. The Company has
one approved product, Vitaros(r), 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(r), 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(r) for ED, such as the room temperature version of Vitaros(r) and
product
candidate Femprox(r) 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(r) in the remaining CMS territories, Spain and Luxembourg;
to successfully commercialize such product and product candidates and other
NexACT(r) product candidates and drug delivery technology; and to achieve its
other development, commercialization and financial goals, such as successfully
manufacturing and launching Vitaros(r) in partnered territories. 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
News Source: NASDAQ OMX
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Language: English
Company: Apricus Biosciences, Inc.
United States
ISIN: US9901429525
End of News DGAP News-Service
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249355 23.01.2014
DGAP-News: Apricus Biosciences Announces National Phase Approval for Erectile Dysfunction Cream - Vitaros(R) in Belgium
| Source: EQS Group AG