Originally, Orexigen and Takeda Pharmaceutical announced that they accepted the recommendation of the Executive Steering Committee (ESC), for early termination of the Light Study, a cardiovascular (CV) outcomes trial that compared the obesity drug Contrave. The study had a total of 8,909 overweight and obese patients with certain CV risk factors.
What Orexigen is saying, is that the Light Study is not being terminated due to a finding of superiority or harm. The ESC, Takeda and Orexigen expect to report the final Light Study data in a scientific forum after all the CV events in the Light Study have been collected and properly adjudicated.
Orexigen released a statement Wednesday morning:
This morning we and Takeda announced termination of the Light Study. We agreed with our partner, and together discussed our preferences with the U.S. Food and Drug Administration (:FDA), that it was best to conclude the study in an orderly fashion, search for and gather all CV events and other safety data, have the CV events properly adjudicated, carefully analyze the final data and have these data presented and published in a scientific forum. …We are pleased that the Light Study is now being terminated and want to thank the patients and all of those involved in the study. This trial has yielded important information about the safety profile for Contrave. …We have been informed that Takeda is on track to initiate a PMR cardiovascular outcomes trial (:CVOT) later this year and recently achieved the first planned milestone with FDA acceptance of the study protocol in April. …Today some of the 50% interim analysis of the Light Study was disclosed by a third party. Because most of our management team remains blinded to the 50% data, we are unable to comment …
Wednesday afternoon, shares of Orexigen were down about 18% at $4.88, in a 52-week trading range of $3.11 to $9.37. The stock has a consensus analyst price target of $13.57.
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