Tokyo, July 30, 2012 (JCN Newswire) - Eisai Co., Ltd. announced today that all rights pertaining to the New Drug Application (NDA) (rights as the marketing authorization holder) for the antiobesity agent BELVIQ(R) (lorcaserin HCl) have been transferred to its U.S. subsidiary Eisai Inc. from Arena Pharmaceuticals, Inc.
With the NDA transfer, Eisai Inc. will become the U.S. marketing authorization holder and will be responsible for commercialization of the drug in U.S., including pharmacovigilance requirements. Furthermore, Eisai Inc. plans to submit marketing authorization applications based on the U.S. NDA to the health authorities throughout the Americas for which it currently holds commercialization rights, including Mexico, Brazil and Canada.
BELVIQ was approved by the FDA on June 27, 2012 (local U.S. time) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight related comorbid condition.
Eisai is committed to providing BELVIQ as a new treatment option for weight management as it seeks to make further contributions to address the unmet medical needs that exist in the medical management of obesity and increase the benefits provided to patients and their families.
About BELVIQ(R) (lorcaserin hydrochloride)
BELVIQ(R), discovered and developed by Arena, is a new chemical entity that is believed to decrease food consumption and promote satiety by selectively activating 2C receptors in the brain. Activation of these receptors may help a person eat less and feel full after eating smaller amounts of food. BELVIQ was approved by the U.S. Food and Drug Administration (FDA) on June 27, 2012 as the first prescription weight-loss treatment to receive approval in the United States in 13 years. BELVIQ was approved by the FDA for the following indications.
Indications and Usage of BELVIQ
BELVIQ is indicated to be used along with a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:
- 30kg/m2 or greater (obese), or
- 27kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes)
Limitations of Use:
- The safety and efficacy of coadministration of BELVIQ with other products intended for weight loss including prescription drugs (e.g., phentermine), over-the-counter drugs, and herbal preparations have not been established
- The effect of BELVIQ on cardiovascular morbidity and mortality has not been established
In July 2010, Eisai's U.S. subsidiary Eisai Inc. entered into an exclusive U.S. marketing and supply agreement for BELVIQ with Arena Pharmaceuticals GmbH, the Swiss subsidiary of Arena. This agreement was amended in May 2012 to expand Eisai's commercialization rights in 20 additional countries throughout the Americas, including Mexico, Brazil and Canada, in addition to the United States.
According to the U.S. Centers for Disease Control and Prevention, over two thirds of adults in the U.S. are either overweight or obese, with the percentage of obese people more than doubling (from approx. 15% to 36%) between 1980 and 2010. Being obese or overweight may be accompanied by other comorbid conditions such as diabetes, hyperlipidemia and hypertension, with the increase in the obese and overweight population constituting a major social problem.
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(R) and Arena(R) are registered service marks of Arena Pharmaceuticals, Inc. BELVIQ(R) is a registered trademark of Arena Pharmaceuticals GmbH.
Eisai Co., Ltd. (TSE: 4523; ADR: ESALY) is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: integrative neuroscience, including neurology and psychiatric medicines; integrative oncology, which encompasses oncotherapy and supportive-care treatments; and vascular/immunological reaction. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system. For more information about Eisai Co., Ltd., please visit www.eisai.com.
Public Relations Department,
Eisai Co., Ltd.
July 30, 2012
Eisai (TSE: 4523) (U.S: ESALY)
From the Japan Corporate News Network
Topic: Press release summary
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