Genzyme's Campath Helps Multiple Sclerosis Patients at 5 Years
Genzyme Corp.’s Campath cut the risk of relapse in multiple sclerosis patients by 69 percent compared with Merck KGaA’s Rebif after five years, according to a study.
Patients on Campath had an annualized relapse rate of 0.11, while for those getting Rebif the rate was 0.35 at the end of five years, according to data presented today at the European Committee for Treatment and Research in Multiple Sclerosis meeting in Sweden. Campath is currently used to treat a type of blood cancer.
The study, from the second of three phases of clinical tests generally required for U.S. approval, is a five-year follow-up to data published in 2008 in the New England Journal of Medicine. Genzyme, based in Cambridge, Massachusetts, is now in the final stage of testing Campath, also known as alemtuzumab, for multiple sclerosis and expects data from those trials in 2011.
“These long-term patient follow-up data suggest that alemtuzumab may have a significant disease-modifying effect in patients with early, active, relapsing-remitting multiple sclerosis,” said Alasdair Coles, a senior lecturer in the Department of Clinical Neurosciences at the University of Cambridge and a lead investigator of the trial, in a statement.
Relapsing-remitting MS, the most common form of the chronic nerve disorder, is characterized by flare-ups of symptoms with some recovery in between relapses.
Genzyme rose 8 cents to $72.68 at 9:41 a.m. New York time in Nasdaq Stock Market composite trading. Before today, the shares gained 48 percent this year, boosted by an unsolicited takeover bid for the company by French drugmaker Sanofi-Aventis SA.
Once Yearly Dosing
In the study, patients on Campath received a course of the medication once annually for two or three years. Campath is given by infusion in a cycle of about five days. Patients on Rebif were given the drug three times weekly for three years.
The research found that 13 percent of patients taking Campath experienced an increase in disabilities compared with 38 percent of those taking Rebif, Genzyme said.
Genzyme’s drug was associated with a 30 percent risk of developing an autoimmune thyroid problem, and six patients taking the drug developed a bleeding disorder called immune thrombocytopenic purpura, or ITP. The first ITP patient’s symptoms weren’t recognized and the disorder led to a fatal cerebral hemorrhage, the company said. One patient in the Rebif arm developed ITP.
Safety, Side Effects
“We’re not convinced that Campath is going to be a big product in multiple sclerosis,” said Phil Nadeau, an analyst with Cowen & Co., in a Sept. 30 telephone interview. “Efficacy looked great, but what will really determine how successful it is will be safety and side effects. In Phase 2 it had some issues.”
Nadeau estimates that Campath could bring in about $500 million in annual revenue with added approval for multiple sclerosis. The drug had less than $150 million in 2009 revenue, according to Genzyme.
Patients are monitored with blood and urine tests to detect such disorders, and most are remedied with treatment, said Michael Panzara, head of Genzyme’s multiple sclerosis and immune diseases unit.
“What we’ve learned, in general, of potent treatments for MS is that you’re going to have a risk of various side effects,” Panzara said in a telephone interview yesterday. “The good news about our profile is we can detect these things.”
2.5 Million People
Multiple sclerosis, which affects about 2.5 million people worldwide including 400,000 in the U.S., is a disease in which the immune system attacks nerve coverings, damaging the brain’s ability to communicate with the rest of the body. The disease can cause blurred vision, loss of balance, slurred speech and tremors among other symptoms, according to the National Multiple Sclerosis Society.
The first pill for the disease on the U.S. market, Gilenya from Novartis AG in Basel, Switzerland, was approved by the U.S. Food and Drug Administration in September. The medicine will compete with drugs given by injection, including Rebif from Darmstadt, Germany-based Merck KGaA, Avonex from Biogen Idec Inc. in Weston, Massachusetts, and Copaxone from Teva Pharmaceutical Industries Ltd. in Petah Tikva, Israel.
Even compared with taking a pill every day, Genzyme’s Campath could be appealing to some patients who prefer to have treatment just once a year, said Nicholas LaRocca, vice president of healthcare delivery and policy research at the Multiple Sclerosis Society.
“Compared to having to do any kind of daily dosing, whether it’s an injection or a capsule, the idea of only having to have a treatment once a year could be very convenient,” LaRocca said in an Oct. 1 telephone interview. “The more options that we can have available for people, the more likely it is that patients will find a therapy that works best for them.”
To contact the reporter on this story: Meg Tirrell in New York at mtirrell@bloomberg.net.
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net.
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