IBDanswers

Tue October 14, 2003
By Sitaraman Shankar

FRANKFURT (Reuters) - German drugmaker Schering AG said on Tuesday that patients on its key Crohn's Disease drug Leukine showed significantly higher response than those on a placebo in a Phase II trial.

"Patients receiving Leukine (sargramostim) for the treatment of moderately to severely active Crohn's disease had significantly greater clinical response and remission rates than those receiving placebo," it said in a statement.

The company said Leukine had met two out of three endpoints in the trial, reducing the severity of Crohn's, a disorder of the gastrointestinal tract, and bringing about remission in some cases.

The drug did not, however, meet its primary endpoint of statistical significance compared to placebo in a 70-point reduction in Crohn's Disease Activity Index (CDAI), a standard measure of treatment effectiveness.

While it lowered CDAI by 70 points in 54 percent of patients, the placebo did this in 44 percent.

But analysts said they were satisfied with the data.

"I have no problem with these results," said Sal Oppenheim analyst Marcus Konstanti.

"The data is satisfying, and the fact that the primary endpoint was not met is not too important as two other, more demanding endpoints were achieved," he said.

Analysts said that more stringent criteria were needed for the primary endpoint to differentiate between the drug and placebo as placebo response was high in Crohn's disease in general.

By 6:16 a.m. EDT Schering shares were down 1.75 percent at 40.88 euros, underperforming the DAX index, which was down 0.33 percent.

A trader said a successful outcome in the trial was already priced in after Schering said on August 28 it would start Phase III trials on the drug as Phase II results were positive.

BIG HOPES

Leukine for Crohn's is one of a basket of promising drugs in the Schering pipeline. The company forecasts peak annual sales of 250 million euros ($290 million) from the drug three years after launch, which analysts expect in 2006.

Schering said on Tuesday that in the Phase II trial, 48 percent of patients taking Leukine had a decrease in the Crohn's Disease Activity Index of more than 100 points, and 40 percent of patients achieved clinical remission by the end of the study, versus 26 percent and 19 percent of the placebo-treated patients respectively.

The study on 124 patients began in 2001 and was conducted at 35 centers following positive results from a 15-patient pilot study.

Leukine is already approved for the treatment of leukemia in adults following chemotherapy, and for four other indications involving bone-marrow and stem-cell transplants.

The drug works by stimulating the immune system.

Analysts say the mechanism underlying its efficacy in Crohn's is not clear.

The current favorite among doctors for treating Crohn's is Johnson & Johnson's Remicade, which works by damping down the body's inflammatory response.