FDA hits brakes on Novartis' hep C program after death

Novartis appears to be well behind the top dogs in the hepatitis C race. U.S. regulators have put a hold on Novartis' ($NVS) clinical trial for an experimental hepatitis C drug alisporivir after cases of pancreatitis were reported in the trial and one patient in the study died. Yet the company hasn't determined that the death was linked to the drug.

The Swiss drug giant has been developing the compound--which blocks a protein linked with reproduction of the liver-damaging virus--amid the well-documented chase to bring safer and swifter treatments for the chronic disease to patients. The death and cases of pancreatitis occurred in a trial involving the use of the drug, also known as DEB025, in combination with pegylated interferon, Dow Jones Newswires reported.

Novartis hasn't been one of standouts in the hep C game--unlike companies with the closely watched interferon-free treatments in development such as Gilead Sciences ($GILD), Bristol-Myers Squibb ($BMY) and Abbott Labs ($ABT). And the setback in the development of alisporivir might not wound the Big Pharma very much.

"The role of the drug in the death remains to be determined. The case is open," Bank Sarasin analyst David Kaegi said, as quoted by Dow Jones, who noted that analysts were keeping very close tabs on the program.

- read the Dow Jones article
- and an Associated Press report

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