ARNA Sheds Light on Belviq Launch - Analyst Blog
May 09 2013 - 11:50AM
Zacks
Arena Pharmaceuticals
Inc. (ARNA) recently announced that the US Drug
Enforcement Administration (DEA) has assigned its obesity drug
Belviq into Schedule IV of the Controlled Substances Act. The
company expects to make Belviq available in the US in a month.
Upon commercialization of Belviq, Arena Pharma will receive $65
million of milestone payment from its partner, Eisai. Eisai will
undertake commercialization responsibilities of Belviq in the
US.
We remind investors that on Jun 27, 2012, Belviq was approved by
the US Food and Drug Administration (FDA) as an adjunct to a
healthy diet (low on calories) and increased physical activity for
chronic weight management in obese or overweight people.
Meanwhile, the company decided to withdraw its Marketing
Authorization Application (MAA) for Belviq in the EU. The Committee
for Medicinal Products for Human Use (CHMP), European Medicines
Agency’s (EMA) advisory body, believes that the results of
nonclinical studies were not sufficient for the drug’s approval.
The company intends to submit the application at a later date.
Arena Pharma has filed regulatory applications for Belviq in
Switzerland. Moreover, the company expects to file regulatory
filings for the drug in Canada, Brazil and South Korea in
near-term.
We remind investors that apart from Belviq, another weight-loss
drug, VIVUS Inc.’s (VVUS) Qsymia, also received
approval in the US last year. Orexigen Therapeutics,
Inc. (OREX) is also developing a candidate, Contrave,
targeting the lucrative obesity market.
Currently, Arena Pharma carries a Zacks Rank #3 (Hold).
Comparatively other biopharma stocks like XOMA
Corporation (XOMA) look better positioned carrying a Zacks
Rank #1 (Strong Buy).
ARENA PHARMA (ARNA): Free Stock Analysis Report
OREXIGEN THERAP (OREX): Free Stock Analysis Report
VIVUS INC (VVUS): Free Stock Analysis Report
XOMA CORP (XOMA): Free Stock Analysis Report
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