Orexigen Therapeutics, Inc.
) rose following the announcement of positive interim data from
the Light Study on its obesity candidate, Contrave. Based on the
encouraging data from the interim analysis, the company plans to
re-submit the new drug application for Contrave to the FDA in the
next few weeks with approval expected by Jun 2014.
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 a
Special Protocol Assessment with the U.S. Food and Drug
The FDA had agreed that Contrave could be approved if the
interim analysis met the specified criteria to exclude
cardiovascular risk (hazard ratio of 2.0 with the upper bound of
a 95% confidence interval using at least 87 events). The interim
analysis met the specified criteria.
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.
Orexigen has submitted a Marketing Authorisation Application to
the European Medicines Agency for Contrave with a final decision
on the approval 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 believe that the positive data from the study has improved the
chances of Contrave being approved in both the U.S. and EU.
Additionally, it will also help Orexigen secure a lucrative
partnership to market Contrave in the ex-North American region.
We note that 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 to be beneficial. The companies are preparing
to launch Contrave.
Orexigen is looking for a partnership in the rest of the world.
However, we note that Contrave, once launched, will be a late
entrant in the obesity market. Last year, two obesity drugs -
Belviq and Qnexa - were approved.
Orexigen carries a Zacks Rank #3 (Hold).
) are better-ranked stocks. While Actelion carries a Zacks Rank
#1 (Strong Buy), Affymetrix holds a Zacks Rank #2 (Buy).
AFFYMETRIX INC (AFFX): Free Stock Analysis
ACTELION LTD (ALIOF): Get Free Report
OREXIGEN THERAP (OREX): Free Stock Analysis
To read this article on Zacks.com click here.