Orexigen Therapeutics, Inc. (OREX - Free Report) entered into a commercial supply agreement with Sanofi (SNY - Free Report) for its obesity drug, Contrave, for territories outside North America. As per the terms of the agreement, Sanofi will manufacture Contrave at one of the facilities in France.
In Oct 2013, Orexigen submitted a marketing authorization application to the European Medicines Agency for Contrave with a final decision expected in the second half of 2014. Subject to regulatory approval, the company plans to launch the drug in early 2015. The company is working on ensuring that Contrave is ready for global supply, once approved.
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 Light study to 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 U.S. Food and Drug Administration (FDA). Based on the outcome of interim analysis, the company plans to re-submit the new drug application for Contrave to the 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 Ltd 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, Belviq and Qsymia, were approved.
Orexigen carries a Zacks Rank #4 (Sell). At present, companies like Actelion Ltd. look well-positioned with a Zacks #1 Rank (Strong Buy).