A tussle over the termination of a trial to assess the cardiovascular safety of obesity drug Contrave is in swing, with Orexigen Therapeutics ($OREX) and Takeda Pharmaceutical entering a dispute process, according to Reuters, with earlier data breaches the subject of a separate issue.
The Cleveland Clinic issued its own statement that the study was halted because trial data was leaked by Orexigen in March and may have compromised data integrity.
For its part, though so far not on its corporate website, Takeda has started a formal dispute process, according to a Reuters story. Among the demands, Reuters said, is that Takeda wants Orexigen to pay the entire cost of the new cardiovascular safety trial slated this year.
A spokesman for Takeda was not immediately available for comment. A company official in Tokyo, who declined to be named, however said that Takeda would issue its own comments when "appropriate."
In its statement, Orexigen said it was "evaluating the assertions made by Takeda and believe they are without merit."
On Tuesday, the Takeda Development Center Americas, a unit of Japan's Takeda Pharmaceutical, and Orexigen Therapeutics in a terse release announced the end of the cardiovascular outcomes trial that compared the obesity drug Contrave to a placebo--in addition to diet and exercise counselling--in 8,909 overweight and obese patients with certain CV risk factors.
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| Cleveland Clinic's Dr. Steven Nissen |
The May 12 release said the companies accepted the recommendation of the Executive Steering Committee chaired by Dr. Steven Nissen of The Cleveland Clinic for early termination.
"The Light Study is not being terminated due to a finding of superiority or harm," according to the release. "The ESC, Takeda and Orexigen expect to report the final Light Study data in a scientific forum after all of the CV events in the Light Study have been collected and properly adjudicated."
"At the time of United States (U.S.) approval of Contrave in September 2014, the U.S. Food and Drug Administration (FDA) required a new CV outcomes trial as a post-marketing requirement (PMR) 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 subjects with CV disease or multiple CV risk factors," the release said.
"This new CV outcomes trial is expected to begin later this year and has a target completion date of 2022."
- here's the story from Reuters
- read the Orexigen release and statement
- and the Cleveland Clinic's statement