Healthcare Industry News: metabolic disease
News Release - July 1, 2010
Eisai Inc. Enters Marketing and Supply Agreement with Arena Pharmaceuticals for LorcaserinA Potential Treatment for Obesity and Weight Management
WOODCLIFF LAKE, N.J.--(HSMN NewsFeed)--Eisai Inc., the U.S. pharmaceutical operation of Tokyo-based Eisai Co., Ltd., announced today that it has entered into an agreement with Arena Pharmaceuticals GmbH, a wholly owned subsidiary of Arena Pharmaceuticals, Inc., for exclusive U.S. rights to commercialize lorcaserin, a drug candidate for potential use in the treatment of obesity, including weight loss, for patients who are obese (Body Mass Index or BMI ≥ 30) or overweight (BMI ≥ 27) with at least one weight-related co-morbid condition. If approved by the Food and Drug Administration (FDA), Eisai will market and distribute lorcaserin in the United States. Arena will handle the manufacture and supply of the finished commercial product at its facility in Switzerland.
“Obesity is one of the most pressing public health issues of our day and one which cannot be overlooked,” said Lonnel Coats, President and Chief Executive Officer, Eisai Inc.
Over one-third of American adults1 are obese according to the Centers for Disease Control and Prevention. Furthermore, the prevalence of obesity in the United States more than doubled (from 15 percent to 34 percent) among adults from 1980 to 2008.
“As part of our human health care (hhc) mission, Eisai is committed to increasing benefits to patients and their families by addressing unmet medical needs,” stated Mr. Coats. “Through this agreement, we believe Eisai has an opportunity to bring a new option to market to address the significant and growing need for medical obesity treatments. Additionally, by building on our expertise and success in the primary care and specialty areas, with strong synergy in our gastrointestinal franchise, this arrangement will enable Eisai to establish a strong presence in the United States for the medical management of obesity.”
“We support the human health care mission and believe that Eisai is the right company to market lorcaserin in the United States,” said Jack Lief, Arena’s President and Chief Executive Officer. “Execution of this commercial agreement is a major milestone in our plans for lorcaserin, and we look forward to working with Eisai to help patients achieve weight loss in a well-tolerated manner.”
Lorcaserin is a single agent that is believed to act as a specific and selective serotonin 2C receptor agonist. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area involved in the control of appetite and metabolism. Stimulation of the serotonin 2C receptor in the hypothalamus is associated with feeding behavior and satiety. An NDA for lorcaserin is currently under review by the FDA, which has assigned a PDUFA date of October 22, 2010. In addition, the FDA has notified Arena of the tentative scheduling of an Endocrinologic and Metabolic Drugs Advisory Committee meeting on September 16, 2010, for the review of the lorcaserin NDA.
About the Phase III Program
The NDA is based on a data package from lorcaserin’s development program that includes 18 clinical trials totaling 8,576 patients. The pivotal Phase III clinical trial program, BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management) and BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management), evaluated nearly 7,200 patients treated for up to two years. In both trials, lorcaserin produced statistically significant and clinically meaningful weight loss and was generally well tolerated. The most frequently reported adverse events in these trials were headache, upper respiratory infection, nasopharyngitis, dizziness and nausea.
These double-blind, randomized, placebo-controlled trials evaluated non-diabetic obese patients (BMI 30 to 45) with or without co-morbid conditions and non-diabetic overweight patients (BMI 27 to 29.9) with at least one co-morbid condition, such as hypertension, cardiovascular diseases or glucose intolerance.
In addition to the pivotal program, Arena is evaluating lorcaserin for weight loss in obese and overweight patients with type II diabetes in its BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus) trial. Arena plans to file the results of BLOOM-DM as a supplement to the NDA.
Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors, an important class of validated drug targets, in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases.
Arena Pharmaceuticals® and Arena® are registered service marks of the company.
Eisai Inc. was established in 1995 and is ranked among the top-20 U.S. pharmaceutical companies (based on retail sales). The company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business with fiscal year 2009 (year ended March 31, 2010) sales of approximately $3.9 billion. Eisai’s areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd.
Eisai has a global product creation organization that includes U.S.-based R&D facilities in Maryland, 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.
Eisai Co., Ltd.
Eisai Co., Ltd. is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care system. Eisai employs approximately 11,000 employees worldwide.
1 Flegal KM, Carroll MD, Ogden CL, Curtin LR. Prevalence and trends in obesity among U.S. adults, 1999-2008. JAMA. 2010 Jan 20; 303(3):235-41. Epub 2010 Jan 13.
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