Eisai and Arena Pharmaceuticals Complete Transfer of BELVIQ® (lorcaserin HCl) New Drug Application
-- Eisai Plans to Submit Applications for Marketing Approval throughout the Americas --
WOODCLIFF LAKE, N.J., and SAN DIEGO, July 30, 2012 /PRNewswire/ -- Eisai Inc. and Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today that Arena has transferred the BELVIQ® (lorcaserin hydrochloride) New Drug Application (NDA) to Eisai. The transfer establishes Eisai as the marketing authorization holder responsible for regulatory activities in the United States related to the commercialization of BELVIQ, including pharmacovigilance
requirements. Arena will continue in its oversight role for the global development of BELVIQ while working closely with Eisai for the joint development plan in the United States.
"The NDA transfer furthers our commitment to BELVIQ as we prepare to launch in the United States and submit applications for approval throughout the Americas," said Lonnel Coats, President and Chief Executive Officer, Eisai Inc.
Eisai plans to submit marketing authorization applications based on the NDA to the health authorities throughout the territories in North and South America for which it currently holds commercialization rights, including Mexico, Brazil and Canada.
"We look forward to further exploring the therapeutic potential of BELVIQ and supporting Eisai's efforts to obtain marketing approval in additional North and South American countries," said Jack Lief, Arena's President and Chief Executive Officer.
About Arena Pharmaceuticals
Arena Pharmaceuticals is a biopharmaceutical company focused on discovering, developing and commercializing innovative medicines that selectively target G protein-coupled receptors. Arena is committed to delivering novel treatment options to patients for weight management, cardiovascular disease, inflammation and other disorders. Arena's US operations are in San Diego, California, and its operations outside of the United States, including its commercial manufacturing facility, are located in Zofingen, Switzerland. For more information about Arena, please visit www.arenapharm.com.
Arena Pharmaceuticals® and Arena® are registered service marks of Arena Pharmaceuticals, Inc.
BELVIQ® is a registered trademark of Arena Pharmaceuticals GmbH.
About Eisai Inc.
Eisai Inc. was established in 1995 and began marketing its first product in the United States in 1997. Since that time, Eisai Inc. has rapidly grown to become a fully integrated pharmaceutical business. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.
Eisai has a global product creation organization that includes US-based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as manufacturing facilities in Maryland and North Carolina. The company's areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based
programs. For more information about Eisai, please visit www.eisai.com/US.
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about Eisai's plans to submit marketing authorizations; Arena's and Eisai's roles in continuing development; the potential launch of BELVIQ; the therapeutic potential of BELVIQ; and Arena's efforts, focus, goals, strategy, research and development programs, and ability to develop compounds and commercialize drugs. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, the following: the timing and outcome of regulatory review is uncertain; risks related to
commercializing drugs, including regulatory, manufacturing and supply issues and the pace of market acceptance; cash and revenues generated from BELVIQ, including timing and impact of competition; government and commercial reimbursement and pricing decisions; risks related to relying on collaborative agreements; the timing and receipt of payments and fees, if any, from collaborators; unexpected or unfavorable new data; nonclinical and clinical data is voluminous and detailed, and regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than Arena or Eisai, request additional information, have additional recommendations or change their guidance or requirements before or after approval; data and other information related to any of Arena's research and development programs may not meet safety, efficacy or other regulatory requirements or
otherwise be sufficient for regulatory review, approval or continued marketing; Arena's ability to obtain and defend patents; the timing, success and cost of Arena's research and development programs; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; clinical trials and other studies may not proceed at the time or in the manner expected or at all; having adequate funds; and satisfactory resolution of litigation or other disagreements with others. Additional factors that could cause actual results to differ materially from those stated or implied by Arena's forward-looking statements are disclosed in Arena's filings with the Securities and Exchange Commission. These forward-looking statements represent Arena's judgment as of the time of this release. Arena disclaims any intent or obligation to
update these forward-looking statements, other than as may be required under applicable law.