Arena Seeks Canadian Approval for Belviq - Analyst Blog

Arena Pharmaceuticals, Inc. ( ARNA ) recently announced the submission of a marketing application for its obesity treatment, Belviq, in Canada. Arena Pharma's partner, Eisai Inc.'s subsidiary, Eisai Limited, submitted a New Drug Submission (NDS) for Belviq to the Canadian regulatory body, Health Canada.

Arena Pharma and Eisai are looking to get Belviq approved in Canada for chronic weight management in addition to a reduced-calorie diet and increased physical activity in adult patients who are obese (initial body mass index (BMI) of ≥ 30 kg per square meter) or overweight patients (BMI ≥ 27 kg per square meter). The patients should have atleast one additional cardiovascular risk factor like hypertension, type II diabetes, dyslipidemia or other such diseases. Arena Pharma is entitled to receive $500,000 from Eisai for the Canada NDS as a milestone payment.

Arena Pharma and Eisai's collaboration for Belviq was initially signed in Jul 2010. Under the marketing and supply collaboration, Eisai gained commercialization rights to Belviq in the US and its territories. In 2012, the agreement was amended and Eisai received commercialization rights in most areas of North and South America.

The obesity market represents huge commercial potential. According to the World Health Organization (WHO), the worldwide obese population has almost doubled since 1980. Furthermore, 1.5 billion people around the globe are overweight with 500 million falling under the obese category.

Earlier this month, Arena Pharma launched Belviq in the US and received a milestone payment of $65 million from Eisai. However, the company has faced some hurdles in gaining approval for Belviq in the EU. In May, Arena Pharma announced that it has withdrawn its application in the EU. However, the company plans to file the application again.

Currently approved therapies for obesity include VIVUS Inc.'s ( VVUS ) Qsymia, which was launched in Sep 2012. Qsymia's sales are yet to pick up - first quarter 2013 sales were $4.1 million.

Arena Pharma currently carries a Zacks Rank #3 (Hold). At present, companies like Jazz Pharmaceuticals Public Limited Company ( JAZZ ) and Santarus, Inc. ( SNTS ) look well positioned with a Zacks Rank #1 (Strong Buy).

ARENA PHARMA (ARNA): Free Stock Analysis Report

JAZZ PHARMACEUT (JAZZ): Free Stock Analysis Report

SANTARUS INC (SNTS): Free Stock Analysis Report

VIVUS INC (VVUS): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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