Eisai Co., Ltd. announced today that it 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* in Latin America and the Caribbean, excluding Brazil, to Eurofarma 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.
*17 countries: Argentina, Belize, Bolivia, Colombia, Costa Rica, Dominican Republic, Ecuador, El Savador, Guatemala, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, Uruguay, Venezuela
[Notes to editors]
- 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 Brazil
With 46 years of existence, the Eurofarma Group is the first Brazilian pharmaceutical multinational with 100% domestic capital, being acknowledged by the medical community and society for promoting access to health and quality of life with treatments at fair price and with quality and innovation.
Present in 20 countries, it operates in the Prescription and OTC, Generic, Hospital, Tender, Oncology, Veterinary and Third-Party Service segments. In Brazil, the portfolio is represented by 335 brands in 844 presentations, including 28 medical specialties and 148 therapeutic classes.
With roughly 6,300 employees, more than of whom 5,000 working in Brazil, the company has one of the largest sales and medical advertising forces and has been for 15 years among the best companies to work for on the main Brazilian rankings.
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