Interesting update on the status of Campath
Genzyme bets Campath to be blockbuster
July 25, 2006 - Reuters - Genzyme is optimistic its cancer drug Campath will become a blockbuster if it is approved to treat multiple sclerosis, a senior executive said.
Campath, which is currently approved to treat B-cell chronic lymphocytic leukemia, a rare blood cancer, generated minimal sales in 2005.
But if the drug is approved for multiple sclerosis it could generate annual sales of more than $1 billion, said Mark Enyedy, senior vice president and general manager of Genzyme's oncology division, in an interview this week.
Campath, which is marketed by Schering AG of Germany, was effective in reducing the risk of relapse in multiple sclerosis patients, according to initial results of a Phase II, or mid-stage, trial.
However, the trial also showed that patients had a higher risk of developing idiopathic thrombocytopenic purpura, a condition that can lead to internal bleeding. Four patients out about 200 who took the drug in a 330-person trial developed ITP and one died, Enyedy said. That has led some analysts to dismiss the drug.
"Our consultants are not overly optimistic about Campath's potential in multiple sclerosis, as they believe that it is too toxic to enjoy widespread use," Cowen & Co. analysts said in a report.
Cambridge, Massachusetts-based Genzyme, however, is more optimistic. The company, which expects to initiate a late-stage, or Phase III, trial of the drug in multiple sclerosis by the end of this year, has developed a risk management program that it believes will be accepted by the U.S. Food and Drug Administration.
"The initial feedback is that the risk management plan is adequate," Enyedy said. "But we need further conversations with the agency, particularly on how it would be implemented in a Phase III study."
Risk management programs are designed to monitor patient safety and typically include patient education, medical monitoring and sometimes controlled distribution.
Last month, in an unusual move, the FDA allowed Biogen Idec Inc. and Elan Corp. to reintroduce their suspended multiple sclerosis drug, Tysabri -- albeit with a strict risk management program -- after it was linked to a rare but potentially fatal brain disease called progressive multifocal leukoencephalopathy, or PML.
The willingness of the FDA to accept a certain amount of risk in return for a drug with greater efficacy than existing treatments of a disease for which there is still no cure, appears to mirror the views of an increasing number of physicians.
According to a survey of 400 neurologists conducted by Genzyme, more than half said they would be willing to accept a very low risk -- defined as one in 1,000 -- of a life-threatening side effect in return for a more effective treatment, Enyedy said. Of 3,000 patients who have taken Tysabri, three developed PML.
The risk of developing ITP with Campath is initially slightly higher than the risk of developing PML with Tysabri, Enyedy said. But he said the risk of ITP is easier to screen than PML, and unlike PML, which typically leads to death or severe disability, ITP is usually treatable.
According to the National Institutes of Health, 250,000 to 350,000 Americans have been diagnosed with MS, a degenerative disease of the central nervous system with no known cure.
Initial results from Genzyme's Phase II trial showed that patients who took Campath had at least a 75 percent reduction in the risk of a relapse in symptoms -- including muscle weakness, blurred vision and disorientation -- than those who took Serono AG's drug Rebif.
Genzyme expects to reveal additional results from its Phase II trial of Campath later this year. If successful, the drug could be approved for multiple sclerosis as early as 2009.
Enyedy said that based on the potential benefit of Campath relative to its risks, the company would most likely price it closer to Tysabri, which costs $28,400 a year, than to other leading multiple sclerosis drugs such as Biogen's Avonex, which costs $18,115.
http://today.reuters.com/news/newsArtic ... AMPATH.xml