FDA OKs Schering’s Hepatitis C Package

Schering-Plough Corp. said Wednesday it has received regulatory approval to sell two hepatitis C drugs in a combination package that’s expected to become the new “gold standard” for treating a disease that affects 4 million Americans.

The U.S. Food and Drug Administration said the New Jersey pharmaceuticals company can sell Peg-Intron, a longer-lasting form of its Intron A drug, in a single-package combination with its Rebetol drug from ICN Pharmaceuticals Inc. of Costa Mesa.

The decision follows an FDA ruling last month granting Schering-Plough the right to sell Rebetol as an individual product, allowing doctors for the first time to mix and match hepatitis C therapies.

The latest FDA ruling enables Schering-Plough to create a single-branded package combining Rebetol and Peg-Intron, for which doctors can write a single prescription. There is no cure for the disease, which can cause fatal liver damage.

Sanford Bernstein analyst Richard Evans predicts that U.S. sales of Schering-Plough’s hepatitis C drugs will double next year to $1.4 billion, with global sales rising 56% to $2.5 billion from $1.6 billion.

The approval should boost ICN, which receives royalties from Rebetol, also known as ribavirin, said Richard Stover, pharmaceutical analyst with Arnhold & S. Bleichroeder in New York. He said he expects ICN’s royalties to nearly double to $300 million next year.

ICN’s earnings have sagged the last nine months as doctors held off prescribing ribavirin in anticipation of the new therapy, said Tom DesChamps, an analyst with Mehta Partners in New York.

Schering-Plough’s stock closed at $38.35, up 17 cents a share, while ICN’s stock was off 13 cents to $32.85.

Schering said Rebetol and Peg-Intron will be available separately this fall. At that point doctors will be able to combine them.

The approval gives Schering-Plough a jump on Swiss rival Roche Holding Ltd., which has developed a competitor to Peg-Intron called Pegasys.

The Peg-Intron and Rebetol combination kept the hepatitis C virus at undetectable levels in 52% of patients tested, compared with 46% of patients using Intron A and Rebetol. But the new regimen had a higher rate of side effects, the FDA said.

While doctors will be free to prescribe Rebetol with either Pegasys or Peg-Intron, analysts expect most doctors will prescribe Schering-Plough’s combination, partly because of the convenience and partly because of Schering-Plough’s marketing clout.

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Reuters and Bloomberg News were used in compiling this report.