Schering shares fall on FDA alert - bad news for Campath 01 December 2005
FRANKFURT (Reuters) - Shares in German drugmaker Schering fell as much as 1.1 percent on Thursday after U.S. regulators issued a health alert over its Campath drug in a trial to treat multiple sclerosis.
Campath is approved to treat a type of blood cancer, but in a study on multiple sclerosis, three patients developed a severe blood disorder and one of them died, the FDA said.
The company initially reported the serious side effect in September and put the trial on hold.
"This is the official posting on the FDA website that pertains exactly to the announcement we made in September. We are still in discussions with the FDA," said a Schering spokesman.
Analysts said the FDA warning was anticipated, but the focus would now be on the future of the drug to treat multiple sclerosis.
"This is the expected official warning," said MM Warburg analyst Ulrich Huwald. "It will now be interesting to see if Schering can go ahead with Phase III trials."
Another analyst, who declined to be named, said: "The FDA obviously wants to spell out the risks to doctors. It's now a challenge to Schering to minimize the risks in future trials so as to get a line extension for multiple sclerosis.
"It's difficult to say what impact it will have on the main use in blood cancer -- it will probably be small," he said.
In its alert, the FDA said patients should talk to their doctors if they were concerned about taking the drug. The agency added it had not reached a final conclusion about the trial's data.
The patients in question developed idiopathic thrombocytopenic purpura, a disorder that causes the body to attack its own platelets and is already mentioned on the drug's label.