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Pancreatitis cases stall Novartis hepatitis C trial

FDA orders halt to clinical trials for alisporivir as investigation is launched

Novartis has been forced to halt a trial of its investigational hepatitis C drug alisporivir after three patients developed acute pancreatitis, which in one case was fatal.

The US Food and Drug Administration (FDA) has ordered a clinical hold on the trial, which was looking at a combination of alisporivir with pegylated interferon and ribavirin, while investigators try to establish whether the pancreatitis was linked to Novartis' drug.

Novartis' global head for the alisporivir programme, Nikolai Naoumov, told the European Association for the Study of the Liver (EASL) annual meeting in Barcelona this week that the investigation is examining whether alisporivir "potentiated a known side effect".

There has only been one death to date in the alisporivir clinical trials programme, with around 1,800 patients receiving the drug to date.

Alisporivir was originally developed by Debiopharm of Switzerland and is a cyclophilin inhibitor that is thought to interfere with proteins the hepatitis C virus needs for replication.

It has generated encouraging data in phase IIb testing, including in a hard-to-treat form of hepatitis C known as genotype 1.

Novartis licensed rights to alisporivir (formerly Deb 025) from Debiopharm in 2010, saying at the time it was an attractive treatment option for hepatitis C because it is an oral agent, it has potent activity across the HCV genotypes, and it has demonstrated a high barrier to viral resistance.

The company had three active studies of the drug in the US ahead of the clinical hold, according to the ClinicalTrials.gov database.

One is looking at the benefit of adding it to standard therapy with pegylated interferon plus ribavirin.

The second is comparing it to Merck/Roche's recently-launched protease inhibitor Victrelis (boceprevir) on top of standard therapy, while a third is examining its effects in patients who have failed protease inhibitor-based treatment for hepatitis C.

Alisporivir's sales potential is considered to be relatively modest, given the plethora of new orally-active hepatitis C agents coming through the pharmaceutical industry pipeline, and Novartis' shares did not react to the news.

20th April 2012

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