Orexigen Therapeutics, Inc.
) recently provided an update on its obesity candidate, Contrave.
The company, which had received a complete response letter (CRL)
from the US Food and Drug Administration (FDA) in Jan 2011 for
Contrave, said that it could be in a position to resubmit the NDA
for Contrave in the second half of 2013.
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 FDA
requested a randomized, double-blind, placebo-controlled trial of
sufficient size and duration which would show that the risk of
major adverse cardiovascular events in overweight and obese
subjects treated with Contrave does not adversely affect its
In Feb 2012, the company reached an agreement with the FDA on
a Special Protocol Assessment (SPA) for the Contrave outcomes
trial and the Light Study was initiated in Jun 2012.
The company said that the Division of Metabolism and
Endocrinology Products (DMEP) has proposed a resubmission
procedure under which an interim analysis report submitted by the
independent Data Monitoring Committee of the Light Study can be
used for the resubmission of the Contrave NDA.
While the timing of the interim analysis depends on the rate
of occurrence of major adverse cardiovascular events in the Light
Study, Orexigen is hopeful of gaining approval in early 2014.
The company has a collaboration agreement with Takeda for the
development and commercialization of Contrave in the US, Canada
and Mexico. Takeda has experience in the metabolic disorder
market which should prove beneficial. However, we note that
Contrave, once launched, will be a late entrant in the obesity
market. Last year, two obesity prevention drugs were approved:
Arena Pharmaceuticals, Inc.'s
) Belviq and
We currently have a Neutral recommendation on Orexigen. The
stock carries a Zacks Rank #3 (Hold). Right now,
) looks attractive with a Zacks Rank #1 (Strong Buy).
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