Apricus Biosciences' Partner in the United Kingdom Accepts First Shipment of Vitaros(R)
April 16 2014 - 8:30AM
Takeda UK to be the First to Launch
Vitaros® in Europe
Apricus Anticipates Follow-On Vitaros
Product Shipments and Launches Throughout 2014
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 that
Takeda Pharmaceuticals International GmbH, the Company's partner in
the United Kingdom, has accepted the first shipment of Vitaros®,
Apricus' novel topical on-demand treatment for erectile dysfunction
("ED").
Richard Pascoe, Chief Executive Officer of Apricus, commented,
"We are excited to have completed the first of several product
shipments of Vitaros® to different territories in Europe this year.
With the commercial availability of Vitaros® in the United Kingdom,
Takeda is in a position to finalize its pre-launch activities in an
effort to be the first Vitaros® commercial partner to offer an on
demand topical cream treatment for men with erectile
dysfunction."
In September 2012, Apricus and Takeda entered into an exclusive
license agreement to market Vitaros® in the UK. According to IMS
Health, the erectile dysfunction market in the United Kingdom was
worth approximately $225 million in 2013, the largest ED market in
Europe. The product received regulatory approval in Europe in June
of 2013 and in August of 2013, Apricus received the national phase
approval to have the product marketed in the United Kingdom.
Earlier this year, Apricus received commercial product orders
from certain of its partners, including Takeda, and commenced
manufacturing of product for these partners through its contract
manufacturer in Canada. In addition to manufacturing commercial
product for its partners, Apricus will also provide clinical
support for its partners' pre-commercialization activities in an
effort to facilitate a consistent launch of Vitaros® throughout
2014.
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 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 further
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®.
For further information on Apricus, visit
http://www.apricusbio.com.
About Takeda UK Limited
Takeda is a research-based global company with its main focus on
pharmaceuticals. As the largest pharmaceutical company in Japan and
one of the global leaders of the industry, Takeda is committed to
strive toward better health for people worldwide through leading
innovation in medicine.
The company has a commercial presence covering around 70
countries, with particular strength in Asia, North America, Europe
and fast-growing emerging markets including Latin America,
Russia-CIS and China. Takeda is ranked 12th by global Rx sales,
14th in the BRIC countries and 18th in Europe. Areas of focus
include cardiovascular and metabolic, oncology, respiratory and
immunology, central nervous system, general medicine, and
vaccines.
Through the integration of Millennium Pharmaceuticals and
Nycomed, Takeda has been transforming itself, broadening its
therapeutic expertise and geographic reach.
Takeda UK, located in High Wycombe, Buckinghamshire, is the UK
marketing and sales organisation of Takeda Pharmaceutical Company
Limited.
More information about Takeda in the UK is available at
www.takeda.co.uk
Forward-Looking Statements
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 the treatment of erectile
dysfunction, such as the room temperature version of Vitaros® and
product candidate Femprox® for the treatment of female sexual
interest/arousal disorder among others, as well as the timing of
such events; the timing of commercial launch of Vitaros® in Europe,
such as the UK, and Canada; to have its product and product
candidates receive additional patent protection and be approved by
the relevant regulatory authorities in Europe, the United States,
Canada and in other countries, such as additional national phase
approvals of Vitaros® in the remaining CMS territory, Spain; and
the ability to achieve our other development, commercialization and
financial goals, including the ability to out-license ex-U.S.
rights to Femprox®, develop a pipeline of products and product
candidates and further complement our management team and/or board
of directors. 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: Steve Martin
Apricus Biosciences
Chief Financial Officer
ir@apricusbio.com
(858) 222-8041
Investors:
Angeli Kolhatkar
Burns McClellan
Senior Vice President
akolhatkar@burnsmc.com
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