Orexigen Therapeutics, Inc., along with Takeda Pharmaceutical Company Limited, has accepted the Executive Steering Committee's recommendation to terminate the Light Study, a cardiovascular outcomes clinical trial comparing obesity medication Contrave to placebo.
Contrave has already received approval from the U.S. Food and Drug Administration back in 2014 but the agency required a new cardiovascular outcomes clinical trial, a post-marketing requirement to aid evaluations for effects associated with long-term use of the drug. The drug is targeted to obese and overweight individuals, which may have cardiovascular disease or multiple risks factors involving cardiovascular health. Takeda will be pushing through with the new clinical trial, which is scheduled to begin later in the year. It is targeted to be completed by 2022.
Orexigen wants to clarify though that the Light Study is not being shut down because of harmful effects being discovered. Data produced from the Light Study will be gathered and analyzed then reported in a scientific forum.
"We ... 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," said Orexigen.
At the time of Contrave's approval, Takeda tried to renegotiate its collaboration agreement with Orexigen, prompting the announcement of a non-binding term sheet. Discussions between the two parties unearthed a previously disclosed non-binding term sheet but did not reach an amicable solution. Takeda has officially initiated a formal dispute process, accusing Orexigen of material breach. In line with this, the company is seeking to have Orexigen shoulder all of the costs of the new cardiovascular outcomes clinical trial it is planning to carry out.
But while the two companies are now entering dispute resolution, which may call for arbitration unless a different resolution comes up, Orexigen is confident that working out problems with Takeda should not affect Contrave's commercialization.
Dr. Steven Nissen, the lead researcher for the Light Study, said interim data from the study showed a reduction in cases of heart attacks, strokes and deaths, but subsequent data highlighted a different trend. However, the results were consistent with FDA requirements calling for the study to demonstrate that cardiovascular risks are not doubled for patients taking Contrave.
According to Takeda, first quarter sales of Contrave in the United States resulted in $11.5 million in net sales; $2.3 million of which went to Orexigen as royalties. Contrave combines two drugs: bupropion and naltrexone. Bupropion is an antidepressant while naltrexone is used for treating addictions.
Photo: Tony Alter | Flickr
