DGAP-News: Apricus Biosciences Receives European Approval for Vitaros(R) for the Treatment of Erectile Dysfunction
(firmenpresse) - Apricus Biosciences, Inc.
10.06.2013 13:00
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Company to Host Conference Call Today at 9:00 AM ET
SAN DIEGO, 2013-06-10 13:00 CEST (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus Bio' or the 'Company') (Nasdaq:APRI)
(http://www.apricusbio.com), today announced that its marketing application for
Vitaros(r), indicated for the treatment of patients with erectile dysfunction
('ED'), has been approved through the European Decentralized Procedure ('DCP').
'The approval of Vitaros(r) in Europe marks a significant milestone for Apricus
Bio as we continue to execute on our core strategy of developing, seeking
regulatory approval, and partnering our sexual health products,' said Richard
Pascoe, Chief Executive Officer of Apricus Bio. 'Vitaros(r) has a unique product
profile that meets the needs of a large number of patients suffering from
erectile dysfunction and who are intolerant to or do not respond to current
treatment options. With its rapid onset of action and unique topical delivery,
we believe that Vitaros(r) will capture a significant share of the approximately
$1 billion PDE-5 inhibitor market in Europe once it is launched by our
commercial partners.'
'Moreover, partnering interest in Vitaros(r) remains strong and we are actively
seeking to secure additional partnerships in the remaining European and global
markets,' continued Pascoe. 'With the completion of a $17.1 million financing,
the divestiture of multiple non-core assets, and streamlining of our global
operations in the second quarter of 2013, Apricus Bio is now well positioned to
advance our lead assets for male and female sexual health, Vitaros(r) and
Femprox(r), in an effort to create long-term shareholder value.'
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 CMS include France, Germany, Italy, UK, Ireland, Spain, Sweden, Belgium and
Luxembourg. The Company will continue to work independently as well as with its
commercialization partners, Sandoz, Takeda, and Bracco for the next step of
obtaining national phase approvals in order to make Vitaros(r) ready to launch in
each of the included territories across Europe.
Conference Call Information
The call will take place today, June 10 at 9:00 AM ET and can be accessed in
the U.S. by dialing 877-407-9210 and outside of the U.S. by dialing
201-689-8049 and asking the conference operator for the Apricus Bio Conference
Call. The conference call will also be webcast live at
www.investorcalendar.com/IC/CEPage.asp?ID=171060. The teleconference replay
will be available for three months by dialing in the U.S. 877-660-6853 and
outside of the U.S. by dialing 201-612-7415. Replay Passcode 415699 is required
for playback. The webcast replay will be available for three months.
About Vitaros(r)
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 besafe 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 a market affecting
nearly 150 million men worldwide and representing approximately $1 billion in
revenue in Europe, Vitaros(r) represents a major market opportunity, particularly
as a distinct product that addresses a significant underserved population.
About Femprox(r)
Femprox(r) is our product candidate for the treatment of female sexual arousal
disorder (FSAD) which contains a topically-applied cream formulation of
alprostadil, a vasodilator, and our proprietary permeation enhancer DDAIP.HCL.
Seven clinical studies have been successfully completed to date, including one,
98-subject Phase 2 study in the US and a nearly 400-subject Phase 3 study in
China. To date, no product has been approved in the U.S. to treat FSAD, a
persistent or recurring inability to attain or maintain adequate sexual
excitement, causing personal distress. Estimates of the FSAD market size put it
on par with erectile dysfunction in males, and possibly larger.
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
Canada, Takeda Pharmaceuticals International GmbH, 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 Phase 3 study
in China.
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 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 and Canada and in other
countries; to successfully commercialize such product and product candidates
and other NexACT(r) product candidates and drug delivery technology; to sell its
oncology supportive care business or assets to a third party or parties; to
cease funding to its French subsidiaries and to have such 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
Argot Partners
212-600-1902
david(at)argotpartners.com
lourdes(at)argotpartners.com
News Source: NASDAQ OMX
10.06.2013 Dissemination of a Corporate News, transmitted by DGAP -
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Language: English
Company: Apricus Biosciences, Inc.
United States
Phone:
Fax:
E-mail:
Internet:
ISIN: US9901429525
WKN:
End of Announcement DGAP News-Service
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