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news.Arena Pharmaceuticals has announced that Eisai Laboratorios, a subsidiary of Eisai, has filed for marketing authorization of Belviq as a treatment for chronic weight management with the Brazilian Health Surveillance Agency (Anvisa).
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In connection with the filing, Arena will receive a milestone payment of $500,000 from Eisai.
Arena Pharmaceuticals president and CEO Jack Lief noted with over half of adults in Brazil being overweight or obese, there is a significant need for new chronic weight management treatments to help address this medical need.
"The filing of this marketing application further illustrates Eisai’s commitment to make BELVIQ available to patients and physicians around the world," Lief added.
Belviq is being submitted for marketing authorization in Brazil as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult obese patients (initial body mass index, or BMI, = 30 kg/m2), or overweight patients (initial BMI = 27 kg/m2) in the presence of at least one weight-related comorbid condition (for example, hypertension, dyslipidemia, cardiovascular disease, type 2 diabetes managed with oral hypoglycemic agents, or sleep apnea).
Eisai is responsible for seeking the regulatory approval and the subsequent marketing and distribution of Belviq in Brazil. Arena has granted Eisai marketing and distribution rights to Belviq for all countries worldwide, except South Korea, Taiwan, Australia, New Zealand and Israel.
Arena manufactures Belviq at its facility in Switzerland, and sells finished commercial product to Eisai for distribution. Arena is eligible to receive payments based upon Eisai’s net sales of Belviq, and is also eligible to receive regulatory and development milestone payments.