Orexigen Therapeutics, Inc. (OREX) recently provided an update on its obesity candidate, Contrave. The company stated that the Independent Data Monitoring Committee for the Light Study expects sufficient major adverse cardiovascular events to occur by Oct 2013, which would facilitate an interim analysis by early December.
Based on the outcome of interim analysis, the company plans to re-submit the new drug application for Contrave to the U.S. Food and Drug Administration (FDA) by the end of this year. The company plans to submit the marketing authorization application for Contrave to the European Medicines Agency before the interim analysis of the Light Study.
We remind investors that the company had received a complete response letter (CRL) from the FDA in Jan 2011 for Contrave. At the time of issuing the CRL, the FDA had expressed concerns regarding the long-term cardiovascular safety profile of Contrave, and had asked Orexigen to conduct an additional study.
The randomized, double-blind, placebo-controlled Light Study is being conducted to assess the risk of major adverse cardiovascular events in overweight and obese subjects treated with Contrave. The study is being conducted under a Special Protocol Assessment with the FDA.
The company has a collaboration agreement with Takeda Pharmaceutical Company Limited (TKPYY) for the development and commercialization of Contrave in North America. Takeda has experience in the metabolic disorder market, which should prove beneficial. Orexigen is looking for partnerships in the rest of the world.
We note that obesity market has two new obesity drugs – Belviq and Qnexa.
Orexigen carries a Zacks Rank #3 (Hold). At present, companies like Biogen Idec (BIIB) and Gilead Sciences, Inc. (GILD) look well-positioned with both being Zacks #1 Ranked (Strong Buy) stocks.
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