Apricus Biosciences Announces the Launch of Its Topical Treatment for Erectile
Dysfunction Vitaros(R) in the United Kingdom
First in a Series of Ex-US Vitaros(R) Launches Expected Throughout 2014
SAN DIEGO, June 16, 2014 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc.
(Nasdaq:APRI), a pharmaceutical company focusing on the development and
commercialization of novel therapeutics for men's and women's health, today
announced the launch of Vitaros^®, Apricus' novel topical on-demand treatment
for erectile dysfunction ("ED"). Vitaros will be marketed in the United
Kingdom by Takeda Pharmaceuticals International GmbH.
Richard Pascoe, Chief Executive Officer of Apricus, commented, "We are pleased
to announce the launch of Apricus' first product, Vitaros, in the United
Kingdom. This launch marks a significant milestone for Apricus and its
partners, as it exemplifies our commitment to bringing novel products to
market that address unmet need.With the launch of Vitaros, the first and only
on-demand topical treatment for erectile dysfunction, we look forward to a
series of Vitaros launches by our commercial partners in Europe and Canada
The launch of Vitaros in the United Kingdom marks the availability of the
first novel ED treatment in Europe in nearly a decade. According to IMS
Health, the ED market in the United Kingdom was approximately $200 million in
2013 based on prescription sales, making it one of the largest ED markets in
Europe. The European PDE-5 inhibitor market is approximately $1.5 billion as
estimated by IMS Health, and analyst estimates for ex-US Vitaros sales are in
the range of $300 million at peak.
Apricus has received multiple commercial product orders of Vitaros from its
partners and is currently manufacturing multiple product batches through its
contract manufacturer in Canada to support launches in Europe. The
commercialization of Vitaros has been fully licensed to these partners, with
Apricus positioned to earn tiered double-digit royalties and more than $200
million in potential milestone payments.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI) is a pharmaceutical company focused on the
development and commercialization of novel therapeutics for men's and women's
health.The Company's lead product, Vitaros, for the treatment of erectile
dysfunction, is approved in Europe and Canada and will be commercialized by
Apricus' marketing partners, which include Abbott Laboratories Limited, Takeda
Pharmaceuticals International GmbH, Hexal AG (Sandoz), Recordati Ireland Ltd.
(Recordati S.p.A.), Bracco S.p.A. and Laboratoires Majorelle.The Company's
second-generation Vitaros^® room temperature device is under development and
is expected to enhance the product's commercial value. Femprox™, the Company's
product candidate for the treatment of female sexual interest/arousal
disorder, has successfully completed an approximately 400-subject
proof-of-concept study.The Company is currently seeking a strategic partner
for Femprox. RayVa™, the Company's product candidate for the treatment of
Raynaud's phenomenon, recently received FDA clearance to begin clinical
studies. The Company intends to begin a Phase 2a trial with RayVa in the
second half of 2014.
For further information on Apricus, visit http://www.apricusbio.com.
This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act, as amended. Statements in this
press release that are not purely historical are forward-looking
statements.Such forward-looking statements include, among other things:
references to the timing of planned launches of Vitaros® in various countries
by Apricus' commercial partners; the potential for Vitaros^® to achieve
commercial success generally or in any specific territory, including Apricus'
receipt of royalties and potential milestone payments from its commercial
partners; the size of the commercial opportunity for Vitaros; and expectations
regarding the commercial value and timing of future product development.
Actual results could differ from those projected in any forward-looking
statements due to a variety of reasons that are outside the control of the
Company, including, but not limited to: Apricus' dependence on Takeda for
sales of Vitaros in the United Kingdom and Apricus' other commercial partners
to carry out the commercial launch of Vitaros in other various territories,
and the potential for delays in the timing of commercial launch; competition
in the ED market and other markets in which Apricus and its partners operate;
Apricus' ability to obtain and maintain intellectual property protection for
Vitaros; Apricus' and its commercial partners reliance on third party
manufactures for the supply and manufacture of Vitaros and its product
candidates; risks and uncertainties related to Apricus' ability to further
develop its second-generation Vitaros room temperature device and its product
candidate RayVa for the treatment of Raynaud's phenomenon; Apricus' ability to
raise additional funding that it may need to continue to pursue its commercial
and business development plans; and market conditions. These forward-looking
statements are made as of the date of this press release, and Apricus assumes
no obligation to update the forward-looking statements, or to update the
reasons why actual results could differ from those projected in the
forward-looking statements. 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 at www.sec.gov or
without charge from the Company.
CONTACT: Steve Martin
Chief Financial Officer
Senior Vice President
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