Hepatitis Studies Could Expand ICN Drug’s Use

A combination of drugs developed by Schering-Plough Corp. and Costa Mesa-based ICN Pharmaceuticals Inc. offers significant benefits in fighting hepatitis C in patients who haven’t ever been treated, new studies found.

The studies are significant because previously the combination of ICN’s Rebetol and Schering-Plough’s Intron-A proved effective for hepatitis C patients who suffered a relapse. The current results could expand use of the drugs.

“Based on these very encouraging results, we are moving quickly to compile data from these studies and file a supplemental new drug application with the U.S. Food and Drug Administration,” said Jonathan Spicehandler, president of Schering-Plough’s Research Institute.

Earlier this month, the companies won the backing of an FDA advisory panel for their drugs’ use in hepatitis C patients who suffered a relapse after previous treatment. Schering-Plough has the U.S. rights to market the combination therapy.

Shares of Madison, N.J.-based Schering-Plough fell $1.94 to close at $86.63, ICN shares fell 6 cents to $47.94.

The two studies compared the effects of the Intron-A/Rebetol combination with Intron-A alone in a total of 1,744 patients.

Six months after a 48-week course of therapy with the drug combination, 41% on the combination had no detectable hepatitis C virus, compared to 16% of patients treated with Intron-A alone.

The results in patients given 24 weeks of therapy were less significant. Six months after the combination group stopped the shorter course of therapy, 33% had no detectable virus compared to 6% in the Intron-A alone group.

Patients were able to tolerate the therapy well, Schering-Plough said, with just slightly more patients dropping out of the combination therapy versus those on the Intron-A alone therapy. The main side effects were flu-like symptoms, fatigue and headache, the company said.

Schering-Plough’s Intron-A is already approved for hepatitis and had sales of $598 million last year. ICN’s Rebetol is currently sold under the brand name Virazole for treatment of respiratory infections.

Hepatitis C has generated more attention as scientists learn more about the condition, first identified in 1989. Experts now estimate that almost 4 million Americans are infected with hepatitis C, a virus most often transmitted through sexual contact, contaminated needles or, before screening tests were available, a contaminated blood transfusion.

Hepatitis C can cause severe liver problems, including cirrhosis, in about 20% of those infected. Others may lead a full life with few problems.

To date, there’s no cure for the condition and many patients fail to derive long-term benefit from available treatments. Amgen Inc. and Roche Holding AG are among the other makers of hepatitis C treatments.