- For Print
- January 5, 2017
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito) announced today that, in association with its U.S. pharmaceutical subsidiary Eisai Inc. (collectively, “Eisai”), it has reached an agreement with Arena Pharmaceuticals, Inc. (Headquarters: California, United States, President and CEO: Amit D. Munshi) to revise the November 2013 marketing and supply agreement it concluded with Arena's wholly owned subsidiary, Arena Pharmaceuticals GmbH (collectively, “Arena”), for the chronic weight management treatment lorcaserin hydrochloride (generic name, U.S. brand name: BELVIQ® / BELVIQ XR®, “BELVIQ”). Under the new agreement, Eisai acquires all of Arena's rights to develop and market BELVIQ.
Under the latest agreement, Eisai becomes solely responsible for all decision-making and implementation related to global development and submissions for regulatory approvals, as well as global marketing for BELVIQ. The previously negotiated financial terms such as purchase price based on net sales and regulatory and sales milestones to Arena have also been reduced and modified. In addition, a technology transfer will take place to allow Eisai to participate in the manufacture of BELVIQ. Eisai will also assume Arena's exclusive distribution agreements with third-parties to develop and market BELVIQ in South Korea, Taiwan and Israel. Eisai will now serve as the third parties' exclusive supplier and receive income in the form of payment for the supply of product to the distributors.
BELVIQ was approved by the U.S. Food and Drug Administration (FDA) in 2012 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 co-morbid condition, and has been available to patients in the United States since June 2013. In addition, BELVIQ has been made available in South Korea via a third-party distributor contracted by Arena from 2015. In 2016, lorcaserin was approved in both Brazil and Mexico, and will be launched in Mexico under the brand name VENESPRI®. In addition, BELVIQ XR, a once-daily formulation of lorcaserin was approved in the United States in 2016.
By seeking to further the development of BELVIQ and to expand its availability to more patients, Eisai anticipates that the new agreement will give it greater freedom in its development and submission strategy, support its goal of making contributions to address unmet medical needs in the clinical management of obesity and increase the benefits for patients and their families worldwide.
Public Relations Department,
Eisai Co., Ltd.
< Notes to editors >
1.About lorcaserin hydrochloride (U.S. brand name: BELVIQ, once daily formulation U.S. brand name: BELVIQ XR)
Discovered and developed by Arena Pharmaceuticals, Inc., lorcaserin is a novel chemical entity that 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. Lorcaserin was approved in June 2012 by the FDA 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 co-morbid condition, and was launched in the United States under the brand name BELVIQ in June 2013 after receiving a final scheduling designation from the U.S. Drug Enforcement Administration (DEA). In addition, lorcaserin has been made available in South Korea via a third-party distributor contracted by Arena from 2015. Lorcaserin was approved in Mexico in July 2016 and in Brazil in December 2016, with the same indication as for the United States.
Furthermore, BELVIQ XR, a once-daily formulation of lorcaserin aiming to increase convenience of administration for patients, was approved in the United States in July 2016.
The most common adverse reactions observed in multiple Phase Ⅲ clinical studies on lorcaserin were headache, dizziness, fatigue, nausea, dry mouth and constipation in patients without diabetes, and hypoglycemia, headache, back pain, cough and fatigue in patients with diabetes. For further information on lorcaserin in the United States, including Important Safety Information (ISI), please visit the BELVIQ product website (http://www.belviq.com).
Furthermore, lorcaserin is currently being investigated in a cardiovascular outcomes trial conducted in multiple countries, including the United States, with 12,000 patients. The three primary outcome measures of the trial concern MACE (Major Adverse Cardiovascular Events including myocardial infarction, stroke and cardiovascular death), conversion to type 2 diabetes mellitus and MACE+ (including myocardial infarction, stroke, cardiovascular death and hospitalization due to unstable angina, heart failure, or any coronary revascularization), respectively. Topline results of the trial are expected in fiscal year 2018.
2.About Worldwide Overweight and Obesity
In recent years, obesity has become a major global health problem, with more than 1.4 billion adults worldwide believed to be overweight and approximately 500 million of that number qualifying as obese. By region, around 170 million people in the United States and 150 million people in Europe are reported to fall into one or both categories, while in Asia, the overweight and obese population includes an estimated 100 million people in China and a further 25 million people in Japan.