Orexigen Therapeutics, Inc. OREX and partner Takeda Pharmaceutical Company Ltd TKPYY announced that they have decided to terminate the Light study on their obesity drug, Contrave, following the recommendation of the Executive Steering Committee (ESC). The companies stated that the study is not being stopped due to any unexpected superiority or harm but after a 50% interim analysis.
The Light study (n=8,909), a cardiovascular (CV) trial, compared Contrave to placebo, in addition to diet and exercise counseling, in overweight and obese patients with certain CV risk factors.
Orexigen said that Takeda is on track to initiate a post-marketing requirement study for the evaluation of the effects of long-term treatment with Contrave on the incidence of major adverse cardiovascular events (MACE) in overweight and obese patients with CV disease or multiple CV risk factors. The study is expected to begin later this year with completion in 2022.
However, concerns have surfaced since the time Light study data has been reported by a third party. According to the third party, the second 25% interim analysis of the Light study demonstrated that a larger number of patients on Contrave experienced MACE compared to placebo (55 versus 43). We remind investors that the first 25% data from the study was made public in which fewer patients on Contrave experienced MACE compared to placebo (35 versus 59). The ESC, Takeda and Orexigen expect to report final data from the study in a scientific forum after a thorough analysis.
Orexigen’s shares plunged 13.6% following the release of the news.
Moreover, Takeda and Orexigen have entered into a dispute resolution process under which the former expects the latter to pay the entire cost of the new CV outcomes trial.
Orexigen carries a Zacks Rank #2 (Buy). Some better-ranked stocks in the health care sector are Gilead Sciences, Inc. GILD and Athersys, Inc. ATHX. Both are Zacks Rank #1 (Strong Buy) stocks.
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