Faced with running additional studies that could take until 2010, Bristol-Myers Squibb said it may terminate development of Pargluva (muraglitazar), its potential blockbuster diabetes drug.
The announcement follows last week's request by the FDA for additional information about cardiovascular safety before making a decision on the drug. Wall Street analysts had predicted that that request could delay launch plans for at least a year. But yesterday the firm said it may need to run additional studies, "because the ongoing trials were not designed to answer questions raised by the FDA" and that these could take five years to complete.
"Bristol-Myers Squibb will continue discussions with the FDA and will consider a range of options including conducting additional studies or terminating further development of muraglitazar," it said in a statement.
The company also said last night that it is in discussions with Merck, its Pargluva marketing partner, to end their collaboration.
In September an agency advisory panel strongly endorsed Pargluva, voting 8 to 1 in favor of approval. Analysts had predicted the drug, after coming to market in 2006, could top $1 billion in sales within several years.
Then came the FDA's request, within an approvable letter, for more information from the clinical trials to evaluate the drug's heart risk.
Later that week, researchers from the Cleveland Clinic, writing in the Journal of the American Medical Association, called for a large study examining Pargluva's long-term heart effect, based on their analysis of existing data showing that it appeared to double the risk of heart attack.
"We continue to believe in the strength of our data and that Pargluva has the potential to be a valuable treatment option for patients with type 2 diabetes," BMS spokesman Jeffrey Schoenborn told MM&M.
Pargluva was on track to become the first FDA-approved product in the class known as dual PPARs, designed to control patients' blood sugar as well as blood cholesterol levels. BMS has another dual PPAR compound in its pipeline, but the drug just began testing in humans, Schoenborn said.
Merck's own diabetes compound sitagliptin, part of another new class of agents called DPP-4 inhibitors, is in phase III studies, and Merck anticipates filing an NDA next year. BMS said its DPP-4 inhibitor, saxagliptin, is also in phase III.