From the Wires
Arena Pharmaceuticals Establishes BELVIQ® (lorcaserin HCl) Marketing and Supply Agreement with Ildong Pharmaceutical for South Korea
-- Arena to Receive 35-45% of Ildong's Net Sales Following Regulatory Approval and Launch of BELVIQ for Treatment of Obese and Overweight Patients in South Korea --
By: PR Newswire
Nov. 6, 2012 04:02 PM
SAN DIEGO, Nov. 6, 2012 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced that its wholly owned subsidiary, Arena Pharmaceuticals GmbH, has entered into a marketing and supply agreement with Ildong Pharmaceutical Co., Ltd., for BELVIQ® (lorcaserin HCl). Under the agreement, Arena granted Ildong exclusive rights to market and distribute BELVIQ (pronounced "BEL-VEEK") in South Korea for weight loss or weight management in obese and overweight patients, subject to regulatory approval of BELVIQ by the Korea Food and Drug Administration (KFDA).
"We are continuing to execute on our vision to broaden the availability of BELVIQ for patients and physicians by establishing collaborations that support the drug's development, approval and commercialization in additional territories worldwide," said Jack Lief, Arena's President and Chief Executive Officer. "We are excited to work with Ildong, a leading Korean pharmaceutical company, to bring this novel weight-loss drug to patients who can benefit from treatment."
Arena will receive from Ildong an upfront payment of $5 million, and an additional $3 million upon the approval of BELVIQ by the KFDA. Ildong is responsible for the development, regulatory approval and, ultimately, marketing and distribution of BELVIQ in South Korea, including related costs and expenses. Arena will manufacture BELVIQ at its facility in Switzerland, and sell BELVIQ to Ildong for a purchase price starting at 35% of Ildong's annual net sales. The purchase price will increase on a tiered basis up to 45% on the portion of annual net sales exceeding $15 million.
"It is a great pleasure to establish this collaboration with Arena for BELVIQ, a new molecular entity that is the product of their research and development expertise," said Jung-chi Lee, Ildong's Chairman and Chief Executive Officer. "We have high expectations that BELVIQ will become a key treatment option for patients in Korea and help address the unmet medical need for obesity drugs."
Scheduled Conference Call and Webcast
Arena will host a conference call and webcast to provide a corporate update today at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). The conference call may be accessed by dialing 877.643.7155 for domestic callers and 914.495.8552 for international callers. Please specify to the operator that you would like to join the "Arena Pharmaceuticals' Corporate Update." The conference call will be webcast live under the investor relations section of Arena's website at www.arenapharm.com, and will be archived there for 30 days following the call. Please connect to Arena's website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.
About Obesity in South Korea
According to a Korea National Health and Nutrition Examination Survey (KNHANES), in 2007 to 2009 approximately one-third of the adult population in South Korea were classified as obese, which is defined by South Korea's obesity standard of body mass index >25 kg/m2. The total cost of obesity in South Korean adults is estimated at $1.3 billion per year.
About BELVIQ® (lorcaserin HCl)
BELVIQ (pronounced "BEL-VEEK") is believed to decrease food consumption and promote satiety by selectively activating serotonin 2C receptors in the brain. Activation of these receptors may help a person eat less and feel full after eating smaller amounts of food.
About Arena Pharmaceuticals
Arena Pharmaceuticals is a biopharmaceutical company focused on discovering, developing and commercializing novel drugs for weight management, cardiovascular disease, inflammation and other disorders. BELVIQ® (lorcaserin HCl), Arena's internally discovered drug, was approved by the US Food and Drug Administration in June 2012, and is under review for regulatory approval in additional territories. Arena's US operations are located 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, visit Arena's website at 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 Ildong Pharmaceutical Co., Ltd.
Ildong Pharmaceutical Co., Ltd., based in Seoul, Korea, is a leading Korean company focused on the development, manufacturing and marketing of pharmaceuticals and OTC products with sales of $294 million in 2011. Ildong, founded in 1941, is known to have leading expertise in various therapeutic categories, including antibiotics, gastrointestinal, anti-diabetics, cardiovascular and oncology. For more information, visit Ildong's website at www.ildong.com.
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 the advancement, therapeutic indication and use, safety, efficacy, mechanism of action, regulatory review and approval, commercialization and potential of BELVIQ; rights and obligations under the marketing and supply agreement with Ildong and the significance of such agreement; expectations and future activities related to such agreement, including the development, regulatory approval of BELVIQ, manufacture and sale of finished product, upfront, milestone and other payments, and commercialization of BELVIQ in South Korea; executing on Arena's vision; broadening the availability of BELVIQ; establishing collaborations that support BELVIQ's development, approval and commercialization in additional territories worldwide; bringing a novel weight-loss drug to patients; the use of BELVIQ by patients and physicians and the benefit to patients; the need for obesity treatments and BELVIQ's impact on such need; and Arena's vision, efforts, focus, goals, strategy, research and development programs, and ability to discover and 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: risks related to the implementation and continuation of the marketing and supply agreement with Ildong and dependence on collaborators; risks related to commercializing drugs, including regulatory, manufacturing and supply issues and the pace of market acceptance; cash and revenues generated from BELVIQ, including the impact of competition; the timing and outcome of regulatory review is uncertain; government and commercial reimbursement and pricing decisions; risks related to relying on collaborative arrangements; the timing and receipt of payments and fees, if any, from collaborators; the entry into or modification or termination of collaborative arrangements; 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 others, 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 may not meet safety, efficacy or other regulatory requirements or otherwise be sufficient for further research and development, regulatory review or 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.
SOURCE Arena Pharmaceuticals, Inc.
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