Orexigen Therapeutics, Inc.
) announced that the U.S. Food and Drug Administration (FDA) is
expected to render a decision on obesity candidate, Contrave, by
Jun 10, 2014. The stock gained 2.7% on the news.
Orexigen had resubmitted the new drug application (NDA) for
Contrave to the FDA in Dec 2013. The company had received a
complete response letter (CRL) from the FDA in Jan 2011. 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 regulatory application was submitted on the basis of an
encouraging summary report by the independent Data Monitoring
Committee on the Light Study. The interim analysis of the
clinical study report (CSR) will be submitted to the FDA by
We note that the randomized, double-blind, placebo-controlled
Light Study (n = 8,900) is underway to assess the risk of major
adverse cardiovascular events in overweight and obese patients
treated with Contrave. The study is being conducted under the
FDA's Special Protocol Assessment program.
Contrave is also under regulatory review in the EU with a final
decision expected in the second half of 2014. Orexigen expects
the interim analysis data from the Light Study to equip the
company to answer the Committee for Medicinal Products for Human
Use Day 120 List of Questions.
We note that the company has a collaboration agreement with
Takeda for the development and commercialization of Contrave in
North America. Takeda has experience in the metabolic disorder
market, which should be beneficial. The companies are planning to
launch Contrave, if approved, in the U.S. in the second half of
It is likely that Contrave will be approved both in the U.S. and
EU given the positive data from the Light Study. This will also
help Orexigen secure a lucrative partnership for Contrave in the
ex-North American region in 2014.
However, we note that Contrave, once launched, will be a late
entrant in the obesity market. Last year, two obesity drugs -
Arena Pharmaceuticals Inc.
) and Eisai Inc.'s Belviq and
) Qsymia - were approved.
Orexigen carries a Zacks Rank #3 (Hold). Some better-ranked
) carrying a Zacks Rank #1 (Strong Buy).
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