From: Reuters
Published January 14, 2008 07:46 PM

Schering says hepatitis drug matches Roche drug

By Ransdell Pierson and Lewis Krauskopf

NEW YORK (Reuters) - The world's leading treatments for hepatitis C were similarly effective in the first large trial pitting them against each other, Schering-Plough Corp said on Monday.

The company said its Pegintron injectable drug and Roche Holding AG's better-selling Pegasys drug both cut the liver damaging virus to undetectable levels in roughly 40 percent of patients.

Schering-Plough also said a lower-dose formulation of its injectable Pegintron was as effective as the standard dose of Pegintron. But the lower-dose formulation caused a similar incidence of side effects as the standard dose of Pegintron, possibly undercutting any potential marketing advantages.

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Both drugs are used in combination with an antiviral pill called ribavirin and are considered the standards of care.

Schering-Plough, which devised the head-to-head trial after U.S. sales of Roche's newer medicine leapfrogged Pegintron, declined to predict whether results of the study would help Pegintron reclaim lost market share.

"This is only top-line data. Overall data will be presented in coming months," Schering-Plough spokesman Bob Consalvo said.

The trial involved 3,070 patients infected with the genotype 1 strain of hepatitis C, the most common but hardest-to-treat form of the virus. An estimated 4 million Americans are believed to be infected with hepatitis C, the leading cause of liver transplants.

None of the patients in the so-called IDEAL trial had previously been treated for the infection.

They were divided into three groups, including one that received standard 1.5 microgram weekly doses of Pegintron plus ribavirin and one that received a 1 microgram weekly dose of Pegintron plus ribavirin. That smaller dose of Pegintron is sold by Schering-Plough but used by a relatively small number of patients who take it as a stand-alone treatment.

Another group in the trial received the standard 180 microgram weekly dose of Pegasys plus ribavirin.

After 48 weeks of treatment and then 6 months of observation, no detectable sign of the virus was found in 41 percent of patients taking Pegasys, in 40 percent of those taking standard doses of Pegintron and in 38 percent of those taking low-dose Pegintron.

"Efficacy in all three groups was similar, with about 40 percent of patients achieving a sustained virologic response," Consalvo said.

"The overall incidence of adverse events for the three regimens were similar," Consalvo said, as were the numbers of patients who dropped out of the trial due to side effects that included flu-like symptoms, fatigue and anemia.

Consalvo said 24 percent of patients taking standard doses of Pegintron experienced relapses, meaning a return of detectable viral infection, after the 48-week treatment period. That was similar to the 20-percent relapse rate among the low-dose Pegintron group.

Although the relapse rate was higher for the Pegasys group, at 32 percent, the percentage of Pegasys patients having no detectable virus levels in the final analysis was similar to the two Pegintron groups.

"The lower relapse rate for the Pegintron patients was meaningful clinically," Consalvo said, but was not deemed statistically significant.

Shares of Schering-Plough were down 6.7 percent to $25.87 in early afternoon trading, which analysts attributed to concern about mixed results from a separate trial involving the company's Vytorin cholesterol fighter.

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