Arena Pharmaceuticals Inc.
) 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
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
We remind investors that apart from Belviq, another weight-loss
) Qsymia, also received approval in the US last year.
Orexigen Therapeutics, Inc.
) 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
) look better positioned carrying a Zacks Rank #1 (Strong
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