February 7, 2006

The FDA has granted fast-track status to Schering-Plough's investigational oral hepatitis C protease inhibitor, a move that comes as the firm reports positive earnings for the fourth quarter of 2005.

The experimental drug (SCH 503034) is now in Phase II clinical development for the treatment of chronic hepatitis C virus (HCV) infection, Schering said recently.

The drug is intended for patients with a HCV genotype 1 strain of the virus who have not responded to combination therapy with pegylated interferon and ribavirin, the current standard of care. The product represents an unmet medical need, said the FDA in granting the fast-track designation. In addition, SCH 503034 is an orally active inhibitor of the hepatitis C virus serine protease that inhibits HCV replication. This mechanism is distinct from those of current therapies, and thus represents a novel class of HCV inhibitor, the agency said.

In other news, Schering reported it had net sales of $2.3 billion in the fourth quarter of 2005, up 6 percent from the previous year's quarter. The firm also reported it had earned $104 million, or 7 cents per share, in the 2005 quarter, compared to a net loss of $856 million, or 58 cents per share, in the previous year's quarter.

"2005 was a pivotal year for Schering-Plough," said Fred Hassan, the company's chairman and CEO. "We began our turnaround phase. We achieved our goal of growing revenues and earnings. We are moving from survive mode into thrive mode."