Apricus Biosciences Receives European Approval for Vitaros(R) for the Treatment of Erectile Dysfunction
June 10 2013 - 7:00AM
Apricus Biosciences, Inc. ("Apricus Bio" or the "Company")
(Nasdaq:APRI) (http://www.apricusbio.com), today announced that its
marketing application for Vitaros®, indicated for the treatment of
patients with erectile dysfunction ("ED"), has been approved
through the European Decentralized Procedure ("DCP").
"The approval of Vitaros® 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® 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® 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® 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® and Femprox®, 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® 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®
Vitaros® 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®, 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 a market affecting
nearly 150 million men worldwide and representing approximately $1
billion in revenue in Europe, Vitaros® represents a major market
opportunity, particularly as a distinct product that addresses a
significant underserved population.
About Femprox®
Femprox® 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®, 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®, 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® for erectile dysfunction , and product
candidate Femprox® 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® 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@argotpartners.com
lourdes@argotpartners.com
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