BMS, Merck end Pargluva pactBristol-Myers Squibb said it will terminate its collaborative agreement with Merck for Pargluva (muraglitazar), the investigational drug to treat type 2 diabetes.
BMS had announced in October that it was weighing whether to end the collaboration, following an FDA request for additional information about Pargluva's cardiovascular safety. To comply with the request, BMS said it would need to run additional studies that could take as long as five years.
The FDA had said it would not approve Pargluva without the additional data on cardiovascular risk, despite the fact that an advisory panel voted overwhelmingly to approve the drug.
Researchers from the Cleveland Clinic also have recommended a large study examining Pargluva's long-term heart effect.
Under their termination agreement, BMS and Merck agreed that all rights to muraglitazar returned to BMS as of Dec. 21. BMS also retained a back-up compound to muraglitazar.
The delay has caused BMS to consider a range of options, it said, including terminating further development of the diabetes compound. The firm said it is continuing discussions with the FDA.