Arena Pharmaceuticals Inc. (ARNA - Free Report) 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 - Free Report) Qsymia, also received approval in the US last year. Orexigen Therapeutics, Inc. (OREX - Free Report) 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 - Free Report) look better positioned carrying a Zacks Rank #1 (Strong Buy).