DGAP-News: Apricus Biosciences, Inc. /
Apricus Biosciences Announces National Phase Approval for Erectile
Dysfunction Cream - Vitaros(R) in Italy
25.11.2013 / 22:40
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Vitaros(r) on Track for European Launch in 2014
Additional Vitaros(r) Partnerships Expected in 4Q 2013
SAN DIEGO, Nov. 25, 2013 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc.
('Apricus' or the 'Company') (Nasdaq:APRI) (www.apricusbio.com), today
announced that the Italian Medicines Agency (AIFA) 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 six national phase
approvals for Vitaros(r), including Germany, Ireland, Italy, the Netherlands,
Sweden and the United Kingdom ('UK') following its broad approval by European
health authorities in June 2013.
'We look forward to working with Bracco, our commercialization partner in
Italy, as they prepare for a successful launch of the first topical, on-demand
treatment for erectile dysfunction in this key European market,' said Richard
Pascoe, Chief Executive Officer of Apricus. 'Our regulatory efforts remain on
track to obtain the remaining four European national phase approvals during the
fourth quarter of 2013 and first quarter of 2014. Looking forward, our top
priorities are to secure additional Vitaros(r) partnerships and support our
commercialization partners' launch preparations in Europe. We expect to
announce one or more additional Vitaros(r) partnerships this quarter and
anticipate the rollout of multiple Vitaros(r) launches across Europe in 2014.'
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 country-by-country national phase
approvals in the remaining CMS territories including France, Spain, Belgium and
Luxembourg. Once the national phase approvals are secured on a
country-by-country basis, marketing of Vitaros(r) can then be initiated in each
country by Apricus' commercialization partners.
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
United Kingdom, Sandoz in Germany, 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.
Apricus has received and reviewed multiple bids for commercialization rights
for Vitaros(r) in the remaining un-partnered territories in Europe and it
expects
to announce additional licensing transactions by year-end 2013.
About Vitaros(r)
Vitaros(r) has been approved for the treatment of ED by 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 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 Biosciences' 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 and guidance on
approval of Femprox(r); 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.
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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241611 25.11.2013
DGAP-News: Apricus Biosciences Announces National Phase Approval for Erectile Dysfunction Cream - Vitaros(R) in Italy
| Source: EQS Group AG