Orexigen Therapeutics, Inc.
) is focused on developing treatment for obesity. Its lead
pipeline candidate is Contrave. Orexigen has submitted a
marketing authorization application to the European Medicines
Agency for Contrave with a final decision on the approval
expected in the second half of 2014. Subject to regulatory
approval, the company plans to launch the drug in early 2015.
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We note that a randomized, double-blind, placebo-controlled Light
Study (n = 8,900) is being conducted to assess the risk of major
adverse cardiovascular events in overweight and obese subjects
treated with Contrave. The company expects data from the study
will be available for the Committee for Medicinal Products for
Human Use Day 120 List of Questions.
Orexigen expects to carry out an interim analysis from the Light
Study by early December. The study is being conducted under a
Special Protocol Assessment with the FDA. 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.
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 company has a collaboration agreement with Takeda
Pharmaceutical Company Limited for the development and
commercialization of Contrave in North America.
However, we note that Contrave, once launched, will be a late
entrant in the obesity market. Last year, two obesity drugs -
Arena Pharmaceuticals, Inc.
) Belviq and
) Qsymia. - were approved.
Orexigen carries a Zacks Rank #4 (Sell). At present, companies
) look well-positioned with a Zacks #1 Ranked (Strong Buy).