Orexigen Therapeutics, Inc.
) 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.
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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
) 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
Orexigen carries a Zacks Rank #3 (Hold). At present, companies
Gilead Sciences, Inc.
) look well-positioned with both being Zacks #1 Ranked (Strong