Arena Pharmaceuticals submits marketing authorisation application in Brazil for BELVIQ for weight management.
NORDIC BUSINESS REPORT-February 13, 2014-Arena Pharmaceuticals submits marketing authorisation application in Brazil for BELVIQ for weight management
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Biopharmaceutical company Arena Pharmaceuticals Inc (NasdaqGS:ARNA) said on Wednesday that it has filed for marketing authorisation of BELVIQ (lorcaserin HCl) as a treatment for chronic weight management in Brazil.
This marketing application was initiated by Eisai Laboratorios Ltda, a subsidiary of Eisai Inc, with the Brazilian Health Surveillance Agency (Anvisa).
In conjunction with the filing, Arena will receive a milestone payment of USD500,000 from Eisai.
According to the company, BELVIQ is being submitted for marketing authorisation in Brazil as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult obese patients in the presence of at least one weight-related comorbid condition.
Under the agreement, Eisai is responsible for seeking the regulatory approval and the subsequent marketing and distribution of BELVIQ in Brazil. Arena has reportedly granted Eisai marketing and distribution rights to BELVIQ for all countries worldwide, except South Korea, Taiwan, Australia, New Zealand and Israel.
BELVIQ is manufactured at Arena's facility in Switzerland, and sells the finished commercial products 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.
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|Publication:||Nordic Business Report|
|Date:||Feb 13, 2014|
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