• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

Genzyme drug helps MS; serious side effect seen

Posted on: Friday, 16 September 2005, 09:49 CDT

By Julie Steenhuysen and Sitaraman Shankar

CHICAGO/FRANKFURT (Reuters) - A drug from Genzyme Corp. and Schering helped reduce the risk of relapses in multiple sclerosis patients, but caused a serious side effect in three cases that led to a death, the companies said on Friday.

Genzyme and Schering have suspended dosing in the trial for Campath, which is approved to treat a form of leukemia, while they work closely with U.S. regulators and clinical investigators "to ensure that a comprehensive approach is in place to manage patient safety," the companies said.

The side effect in the Phase II or mid-stage trial included three cases of idiopathic thrombocytopenic purpura, or ITP, a condition in which patients experience a low platelet count that can result in abnormal bleeding.

One patient died from the condition. Two remaining cases are being treated.

Genzyme and Schering said they have notified regulatory authorities, trial sites and patients about risks. The companies have consulted a panel of experts to advise the companies on how to reduce risks of ITP.

The companies are in talks with the U.S. Food and Drug Administration about what steps might be needed to protect patient safety.

Analyst views differed widely on the results, with Citigroup seeing the data as a strong positive for the stock, and Deutsche Bank expressing doubt about Campath's approval.

"This is a mixed result," said Sal. Oppenheim analyst Marcus Konstanti. "The drug seems very efficacious but with severe side effects. The question is whether the companies can bring a low dose to market or whether there are strong measures to control side effects."

He said the result could delay the launch of Campath in treating multiple sclerosis beyond his earlier expectation of 2009 or 2010.

Treatments for multiple sclerosis already are under a spotlight after the drug Tysabri, made by Ireland's Elan Corp. and Cambridge, Massachusetts-based Biogen Idec Inc., was pulled from the market in February after it was linked to a rare and potentially fatal brain disease.

"Given the recent heightened scrutiny related to Tysabri safety concerns, we are skeptical that Campath will eventually become a treatment for multiple sclerosis," said Deutsche Bank biotech analyst Jennifer Chao in a research note.

She said Campath's safety and efficacy potential make it a suitable cancer treatment, given the potential for saving lives, but MS is a chronic autoimmune disease that may not warrant the same risk of severe side effects.

Citigroup analyst Yaron Werber, however, said the results could represent "a major advance in MS treatment."

A Schering spokesman said the company was giving no launch date or peak sales forecast for the drug in treating multiple sclerosis.

Campath had sales of 63 million euros or $77 million last year from its use in treating leukemia.

COMPARISON WITH REBIF

Schering shares reacted little to the announcement, trading slightly higher at 51.1 euros, but underperforming a 1.3 percent rise in the DAX blue-chip index. Genzyme's sales gained 57 cents, or .8 percent, to $72.23 in morning trade on Nasdaq.

While Campath met one of its key goals, reducing relapse, it just missed a second, which was to show a statistically significant reduction in the risk of progression of clinically significant disability.

The companies said they will continue to collect both efficacy and safety data from this Phase II trial -- which compared Campath (alemtuzumab) with Rebif, a drug from Switzerland's Serono -- while preparing to initiate a Phase III trial.

In Switzerland, Serono shares were also flat at 840 Swiss francs.

Schering is keen to expand its multiple sclerosis franchise because its flagship drug, Betaseron, is facing strong competition from Rebif, Teva's Copaxone and Biogen Idec's Avonex.

Source: REUTERS

More News in this Category