DGAP-News: Apricus Biosciences Receives National Phase Approvals for Vitaros(R)
in Ireland and the Netherlands
Apricus Biosciences, Inc.
SAN DIEGO, 2013-08-15 13:00 CEST (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus Bio' or the 'Company') (Nasdaq:APRI)
(www.apricusbio.com), today announced that the Irish Medicines Board and the
Netherlands' Medicines Evaluations Board have each granted national phase
approvals to Vitaros(r), indicated for the treatment of patients with erectile
dysfunction ('ED'). The Company has now received a total of four national phase
approvals for Vitaros(r) including Ireland, the Netherlands, Sweden and the
United Kingdom ('UK').
In June 2013, Apricus Bio announced that its marketing application for
was approved through the European Decentralized Procedure ('DCP'). Under the
DCP, Apricus Bio filed its application for marketing approval designating
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 independently, as well as with its commercialization
partners, to obtain country-by-country national phase approvals in the
remaining CMS territories including France, Germany, Italy, 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 Bio's commercialization partners.
'Vitaros(r) has now received national approvals in four of the ten European
countries where marketing authorization applications are being pursued,' said
Richard Pascoe, Chief Executive Officer of Apricus Bio. 'We believe that
Vitaros(r) is on track to obtain the remaining European approvals beginning in
the third quarter of this year and continuing through the first quarter of
2014. Our regulatory efforts, along with the actions taken by our existing
European partners, Takeda, Sandoz and Bracco, continue to move successfully
toward making Vitaros(r) ready to launch in each of the included territories
Vitaros(r) is currently partnered in key markets, including with Takeda in the
UK, Sandoz in Germany, Bracco in Italy and Abbott in Canada. Apricus Bio
recently launched a comprehensive partnering process with the goal of licensing
Vitaros(r) in the remaining un-partnered territories in Europe, Latin America
North Africa. The Company is reviewing bids recently received from multiple
interested parties for the available territories and Company expects the
Vitaros(r) partnering process to be completed in the fourth quarter of 2013.
Once launched, Vitaros(r) will become the first new and novel erectile
dysfunction 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
these existing therapies, or who are intolerant to the systematic effects of
PDE5 inhibitors, it is well-positioned for commercial success. In Europe alone,
the existing erectile dysfunction products generated over $1 billion in sales
in 2012. Apricus Bio believes that a significant portion of the market remains
untreated or under-treated, which represents a substantial commercial
opportunity for Vitaros(r).
Vitaros(r) has been approved for the treatment of Erectile Dysfunction ('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 erectile dysfunction and an ED market size of approximately $1 billion in
revenue in Europe alone, Vitaros(r) represents a major market opportunity for
Apricus Bio 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 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(r), for the treatment of
erectile dysfunction, which is now approved in Europe and Canada and will be
commercialized by Apricus Bio's marketing partners, which include Abbott
Laboratories Limited, Takeda Pharmaceuticals International GmbH, Hexal AG
(Sandoz), and Bracco SpA. Femprox(r), the Company's product candidate for the
treatment of female sexual arousal disorder, has successfully completed a
nearly 400-subject proof-of-concept study.
For further information on Apricus Bio, visit http://www.apricusbio.com.
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 product
Vitaros(r) for erectile dysfunction, and product candidate Femprox(r) for Female
Sexual Interest and 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; to successfully commercialize such product and
product candidates and other NexACT(r) product candidates and drug delivery
technology; to have its French subsidiaries reorganize or liquidate
successfully; and to achieve its other 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 Bio Investor Relations:
David Pitts or Lourdes Catala
News Source: NASDAQ OMX
15.08.2013 Dissemination of a Corporate News, transmitted by DGAP -
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Company: Apricus Biosciences, Inc.
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