Apricus Biosciences, Inc.
10.05.2013 14:30
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Company to Host Conference Call/Webcast Today at 9:00 AM ET
SAN DIEGO, 2013-05-10 14:30 CEST (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus Bio' or the 'Company') (Nasdaq:APRI)
(http://www.apricusbio.com), today provided an update regarding ongoing
corporate activities and announced that it expects to file its Quarterly Report
on Form 10-Q for the quarter ended March 31, 2013 with the Securities and
Exchange Commission on Friday, May 10, 2013. As previously announced, the
Company will host its first quarter 2013 financial results conference call
today, May 10, 2013 at 9:00 a.m. ET.
'Apricus Bio began 2013 with a newly focused corporate strategy aimed at the
commercialization, through partnerships, of its lead product Vitaros(r) for
erectile dysfunction ('ED') and the development of its lead product candidate
Femprox(r) for female sexual arousal disorder ('FSAD'),' said Richard Pascoe,
Chief Executive Officer of Apricus Bio. 'Since the beginning of the year, we
have made important progress in support of that goal, including the successful
divestiture of multiple non-core assets, streamlining of our operations to
better align them with our objectives, and advancement of our regulatory and
commercial strategy for Vitaros(r) and Femprox(r). We continue to believe that
the
greatest opportunity for shareholder value creation remains in the global
development and commercialization, through strategic partnerships, of these
lead assets.'
Recent Corporate Developments
-- European approval decision for Vitaros(r) in Europe via the Decentralized
Procedure ('DCP'). We are currently awaiting a decision regarding the
approval of Vitaros(r) in Europe via the DCP with The Netherlands serving
as
the Reference Member State ('RMS'). In April of 2013, Apricus Bio, in
consultation with our European commercialization partners, submitted to the
RMS our response to the Day 120 List of Questions ('LOQ'). This week, which
marked Day 180 of the regulatory approval process, the RMS confirmed that
the major nonclinical, clinical and clinical safety issues outlined in the
Day 120 LOQ have been resolved. While the regulatory review process is
ongoing, and we remain in active dialogue with the RMS on certain remaining
matters included in the Day 180 response, we believe that the marketing
approval process for Vitaros(r) in Europe remains on track for an approval
decision on Day 210 of the process assuming there are no other
interruptions in the review process. If Vitaros(r) is approved by the RMS,
our commercialization partners will commence with the National Phase
approvals in their respective territories. Once those approvals are secured
on a country-by-country basis, marketing of Vitaros(r) can then be
initiated
in each country by our commercialization partners. In Europe, existing ED
products generated over $1 billion in sales in 2012 and Apricus Bio
believes that a significant portion of the market remains untreated or
undertreated, which represents a significant commercial opportunity for
Vitaros(r).
-- Commercial Launch of Vitaros(r) in Canada. Vitaros(r) is approved in
Canada,
and Apricus Bio licensed Vitaros(r) to Abbott Canada for commercialization
of
the product in that territory. Abbott remains fully committed to a
successful launch of the cold-chain version of Vitaros(r) in Canada in the
shortest timeframe possible. Abbott is working with their contract
manufacturer to optimize the product's shelf-life period, which is driven
by specifications that are applicable only to the product that will be sold
in Canada, prior to launching the product in that market. As a result of
these ongoing developments, Abbott has confirmed that a Vitaros(r) launch
in
Canada in the first half of 2013 will not occur.
-- Femprox(r) Development Program: Femprox(r) is our lead product candidate
for
the treatment of female sexual arousal disorder, or FSAD. To date, we have
completed seven clinical studies with Femprox(r) including a 100 patient
Phase 2 study in the U.S. and a 400 patient Phase 3 study in China. The
data generated from these studies strongly suggests that Femprox(r) has the
potential to effectively treat FSAD in a female patient population where
there are currently no available FDA approved treatment options. Moreover,
we believe that Femprox(r) could be the first and only on-demand treatment
approved for FSAD, where estimates of the market size are on par with that
found in the erectile dysfunction market. The Company continues to advance
the Femprox(r) development program in close consultation with our clinical
and regulatory advisors. Our near-term goal is to seek confirmatory
regulatory guidance from the U.S. FDA in the form of an End-of-Phase 2
meeting.
-- Divestiture of Non-Core Assets: The Company sold its product, Totect(r)
(dexrazoxane HCl), a marketed, injectable treatment for anthracycline
extravasation, to Biocodex USA ('Biocodex') in March 2013, in line with its
recently updated corporate strategy. Under terms of the arrangement,
Apricus Bio received an upfront payment at closing and is eligible to
receive royalties on net sales of Totect(r) by Biocodex through 2016, in
exchange for Apricus Bio's sale of its commercialization rights to
Totect(r)
in North America and South America.
Conference Call Information
The call 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
http://www.investorcalendar.com/IC/CEPage.asp?ID=17095. The teleconference
replay will be available for one week by dialing in the U.S. 877-660-6853 and
outside of the U.S. by dialing 201-612-7415. Replay Passcode 413843 is required
for playback. The webcast replay will be available for three months.
About Vitaros(r)
Vitaros(r), Apricus Bio's lead product candidate for the treatment of ED, is a
topically-applied cream formulation of alprostadil, a vasodilator, which
directly increases blood flow to the penis, causing an erection. Alprostadil is
a widely accepted alternative to the PDE5 inhibitors for difficult to treat
patients, and Vitaros(r) is relatively safe and effective, and offers greater
market opportunity due to its patient-friendly form versus both other
alprostadil dosage forms and also relative to oral ED products. With a market
affecting nearly 150 million men worldwide and representing approximately $2.6
billion in revenue - excluding the U.S. - Vitaros(r) represents a major market
opportunity, particularly as a distinct product that addresses a significant
underserved population.
About Femprox(r)
Femprox(r) is a product candidate for the treatment of female sexual arousal
disorder (FSAD). 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 will be marketed in Canada by Abbott Laboratories,
and Femprox(r), a product candidate, for the treatment of female sexual arousal
disorder.
For further information on Apricus Bio, visit http://www.apricusbio.com. You
can also receive information at http://twitter.com/apricusbio.
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 candidates 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 through
Abbott and its other licensees; 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
News Source: NASDAQ OMX
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Language: English
Company: Apricus Biosciences, Inc.
United States
Phone:
Fax:
E-mail:
Internet:
ISIN: US9901429525
WKN:
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DGAP-News: Apricus Biosciences Provides First Quarter 2013 Corporate Update
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