Takeda UK to be the First to Launch Vitaros® in Europe
Apricus Anticipates Follow-On Vitaros Product Shipments and Launches Throughout 2014
SAN DIEGO, April 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 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.