TOKYO, Oct 16, 2018 - (JCN Newswire) - Eisai Co., Ltd. has entered into an agreement to grant exclusive development and marketing rights for its anti-obesity agent lorcaserin hydrochloride (generic name, product name in the United States: BELVIQ, product name for once-daily formulation in the United States: BELVIQ XR, "lorcaserin") in 17 countries(1) in Latin America and the Caribbean, excluding Brazil, to Eurofarma Laboratorios S.A. which has a business foundation in Latin America.
Under this agreement, Eisai will supply Eurofarma with lorcaserin. Eisai will receive a one-time contractual payment and is eligible for milestone payments for development and sales in each country.
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. Lorcaserin was approved in 2012 by the U.S. Food and Drug Administration (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 in June 2013. Lorcaserin was approved in Mexico and Brazil with the same indication as for the United States in July 2016 and December 2016, respectively.
By entering into this agreement with Eurofarma, which has a strong business foundation throughout the region, Eisai aims to continue its effort to make lorcaserin widely available to appropriate patients as soon as possible.
(1) 17 countries: Argentina, Belize, Bolivia, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, Uruguay, Venezuela
About lorcaserin hydrochloride (product name in the United States: BELVIQ, product name for once-daily formulation in the United States: BELVIQ XR, "lorcaserin")
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 U.S. Food and Drug Administration (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 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. In January 2017, Eisai acquired all of Arena's rights to develop and market lorcaserin.
In August 2018, in a cardiovascular outcomes trial (CAMELLIA-TIMI61) of lorcaserin, a post-marketing clinical trial evaluating safety as the primary objective, it was confirmed that lorcaserin did not increase the incidence of major adverse cardiovascular events (MACE: defined as cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) compared to placebo, and the primary safety objective was met. Regarding the primary efficacy endpoint of incidence of MACE+ (consisting of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, hospitalization due to unstable angina, heart failure or coronary revascularization), statistical non-inferiority compared to placebo was confirmed for lorcaserin. Data on the effect of lorcaserin on prevention and remission of type-2 diabetes mellitus was announced in October 2018.
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.
About Worldwide Overweight and Obesity (Eisai's internal estimates)
In recent years, obesity has become a major global health problem, with more than 1.4 billion adults worldwide believed to be overweight (BMI of 25 kg/m2 or greater) and approximately 500 million of that number qualifying as obese (BMI of 30 kg/m2 or greater). 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.
In Latin America as well, obesity is becoming a serious health issue, with approximately 125 million patients diagnosed with obesity. Due to changes in lifestyle and other factors, the incidence of obesity is expected to increase from approximately 20% at present to approximately 30% by 2024.
About Eurofarma Laboratorios S.A. (Eurofarma)
Founded in 1972, Eurofarma is one of the largest pharmaceutical companies in Brazil and is present in 20 countries in South and Central America, the Caribbean and Africa. In addition to Brazil, it has its own operations in Argentina, Bolivia, Chile, Colombia, Ecuador, Guatemala, Paraguay, Peru and Uruguay, and also sells products in Belize, Costa Rica, Dominican Republic, El Salvador, Honduras, Mexico, Nicaragua, Panama, Venezuela and Mozambique. Eurofarma's capabilities span from research and development to clinical trial execution to marketing and sales of in-licensed and wholly owned products. Eurofarma's mission is to promote access to health and quality of life with reasonably priced treatments while maintaining a profitable operation to assure sustainable growth and share the value generated with employees and society. To learn more about Eurofarma, please visit www.eurofarma.com.br.
Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products in various therapeutic areas with high unmet medical needs, including Neurology and Oncology.
Furthermore, we invest and participate in several partnership-based initiatives to improve access to medicines in developing and emerging countries.
For more information about Eisai Co., Ltd., please visit www.eisai.com
Public Relations Department,
Eisai Co., Ltd.
Oct 16, 2018 17:38 HKT/SGT
Eisai (TSE: 4523)
Topic: Press release summary
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