DGAP-News: Apricus Biosciences Announces National Phase Approval for Erectile
Dysfunction Cream - Vitaros(R) in Germany
Apricus Biosciences, Inc.
First Topical, Fast-Acting, On-Demand Treatment for Erectile Dysfunction
Approved in One of Europe's Largest Markets
Apricus Remains On-Track to Announce Additional Vitaros(r) Partnering
in Q4 2013
SAN DIEGO, Oct. 7, 2013 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ('Apricus
Bio' or the 'Company') (Nasdaq:APRI) (www.apricusbio.com), today announced that
Germany's Federal Institute for Drugs and Medical Devices (BfArM) 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 five
national phase approvals for Vitaros(r), including Germany, Ireland, the
Netherlands, Sweden and the United Kingdom ('UK').
'National phase approval of Vitaros(r) in Germany, one of the largest ED markets
in Europe, is another important milestone for the Company,' said Richard
Pascoe, Chief Executive Officer of Apricus Bio. 'We look forward to working
with Sandoz, our commercialization partner in Germany, to move Vitaros(r) toward
a successful launch in this key territory. Our regulatory efforts, along with
actions taken by our existing European partners, continue to be on track to
obtain the remaining five of ten European approvals from the fourth quarter of
2013 through the first quarter of 2014.'
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, 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.
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 systematic effects of PDE5 inhibitors, it is
well-positioned for commercial success. In Europe alone, the existing ED
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) is currently partnered in key markets, including with Takeda in the
UK, Sandoz in Germany, Bracco in Italy and Abbott in Canada. Apricus Bio has
launched a comprehensive partnering process with the goal of licensing
in the remaining un-partnered territories in Europe, Latin America and North
Africa. Apricus Bio has received and reviewed multiple bids for the available
territories and has narrowed the number of potential partners to a select group
with which it will negotiate terms. Moreover, the Company remains on track to
complete this process in the fourth quarter of this year.
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 ED, 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; 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. 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
07.10.2013 Dissemination of a Corporate News, transmitted by DGAP -
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Company: Apricus Biosciences, Inc.
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