Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today that Eisai Limited (based in Mississauga, Ontario), a subsidiary of Eisai Inc., has submitted a New Drug Submission (NDS) for BELVIQ™ (lorcaserin HCl) with Health Canada. BELVIQ is being evaluated in Canada as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management (including weight loss and weight maintenance) 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 additional cardiovascular risk factor (e.g., hypertension, dyslipidemia, type 2 diabetes, or sleep apnea). In connection with the NDS, Arena will receive a milestone payment of $500,000 from Eisai.
"Approximately 60 percent of Canadians are overweight or obese, but there are limited treatment options available in Canada beyond diet and exercise," said Jack Lief, Arena's President and Chief Executive Officer. "With this New Drug Submission for BELVIQ, we hope to provide physicians with a new tool to help motivated patients manage their weight."
Eisai is responsible for the regulatory approval and, ultimately, marketing and distribution of BELVIQ in Canada. Beyond Canada, Arena has granted Eisai marketing and distribution rights to BELVIQ in most of North and South America. 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.
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