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Eisai submits new drug submission for Belviq with Health Canada
San Diego | Friday, June 28, 2013, 09:00 Hrs  [IST]

Arena Pharmaceuticals, Inc. announced that Ontario-based, Eisai Limited which is 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 per cent 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.

Belviq is believed to decrease food consumption and promote satiety by selectively activating serotonin 2C receptors in the brain. The exact mechanism of action of Belviq is not known.

Belviq (lorcaserin HCl) CIV is approved by the US Food and Drug Administration (FDA).

Arena is a biopharmaceutical company focused on discovering, developing and commercializing novel drugs that target G protein-coupled receptors, or GPCRs, to address unmet medical needs.

Eisai Inc. is focussed on human health care and gives its first thoughts to patients and their families, and helping to increase the benefits health care provides.

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