In late October, after the FDA said it wanted additional information about the drug’s cardiovascular risks, the company said it would walk away from the new PPAR inhibitor for type-II diabetes. But on Monday, the BMS insisted that it remains in serious negotiations with Merck, its partner in Pargluva (muraglitazar) development.
“It’s only been a month since we released our statement, and the status hasn’t really changed since then,” said Bristol-Myers spokesperson David Rosen, referring to the joint statement Bristol-Myers issued with Merck. “We are determining what is going to be the path going forward, but it’s too soon to determine what the final outcome is going to be based on all of our options,” Rosen added.
But some analysts wonder if the project can still go forward. They say Pargluva was a bad bet from the beginning.
“We had written a couple of reports on Pargluva before the FDA advisory committee came out,” said Barbara Ryan, managing director of Deutsche Bank, who predicted in a July interview with PharmExec that FDA would not approve the drug. “There were potentially worrisome liabilities on the cardiovascular side,” Ryan said in July.
However, just a few months ago, it looked as though FDA would approve the drug. On September 9, FDA’s Endocrinologic and Metabolic Drugs Advisory Committee gave Pargluva an 8-1 recommendation for approval. On October 18, both companies received an “approvable letter.”
But in response to the approvable letter, the Journal of the American Medical Association rushed into print with a study suggesting that Pargluva had links to heart attacks and strokes. Conducted by researchers at the Cleveland Clinic and co-authored by Dr. Steven E. Nissen, the study provoked comparisons with Vioxx, Merck’s withdrawn COX-2 painkiller.
Pargluva, an investigational oral medication, would have become the first marketed agent in a new class of compounds called glitazars. A dual peroxisome proliferators-activated receptor (PPAR) alpha/gamma agonist, the drug reduces plasma glucose and triglyceride levels while increasing the “good” cholesterol levels for type-II diabetics.
Then, instead of issuing final approval, FDA said it wanted more information about Pargluva’s cardiac risks. Rather than pursue additional studies, which Deutsche Bank’s Ryan said would cost up to $100 million, the companies said they would abandon the drug.
The announcement couldn’t have come at a more inconvenient time for Merck, still under siege after the withdrawal of Vioxx. But Pargluva’s failure dealt an even more resounding blow to BMS, who needed Pargluva to counter a recent accounting scandal that cost the company hundreds of millions of dollars in federal penalties and civil settlements.
“It remains a mystery to me why Merck even signed the deal in the first place,” said Ryan. “It’s a bigger deal for Bristol-Myers because they were counting on [the success of Pargluva] financially. It’s a big blow for Bristol because they have not had growth for many years and they still need to demonstrate that they can produce a successful drug.”