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, Chinese 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.