Orexigen Therapeutics, Inc. (OREX - Free Report) 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.
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.’s (ARNA - Free Report) Belviq and VIVUS Inc.’s (VVUS - Free Report) Qsymia. - were approved.
Orexigen carries a Zacks Rank #4 (Sell). At present, companies like Actelion Ltd. look well-positioned with a Zacks #1 Ranked (Strong Buy).