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UPDATE: Arena Pharma Issues Update on Upcoming US Launch of BELVIQ, to Get $65M Milestone Payment from Eisai

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Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today that the Office of the Federal Register filed for public inspection the US Drug Enforcement Administration's (DEA) final rule placing BELVIQ ^ (pronounced BEL-VEEK) into Schedule IV of the Controlled Substances Act. The scheduling designation will be effective 30 days after tomorrow's expected publication in the Federal Register. Following the effective date, BELVIQ will be available to patients in the United States by prescription, and Arena will receive $65 million in milestone payments from Eisai Inc. under their marketing and supply agreement.

BELVIQ is approved for use 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/m^2 or greater (obese), or 27 kg/m^2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes). The indication includes the following limitations of use: The safety and efficacy of coadministration of BELVIQ with other products intended for weight loss and the effect of BELVIQ on cardiovascular morbidity and mortality have not been established.

"We are thrilled that BELVIQ will soon be available in the United States as a new treatment option for the medical management of patients who are overweight with a comorbidity or obese," said Jack Lief, Arena's President and Chief Executive Officer.

Eisai is responsible for the marketing and distribution of BELVIQ in the United States. Arena manufactures BELVIQ at its facility in Switzerland, and sells finished commercial product to Eisai for a purchase price starting at 31.5% of Eisai's annual net product sales. The purchase price increases on a tiered basis up to 36.5% on the portion of annual net product sales exceeding $750 million. Arena is also eligible to receive $1.16 billion in purchase price adjustment payments based on annual net sales levels of BELVIQ.

Posted-In: News FDA

 

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