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Monday
CAMPATH: "Genzyme Says MS Drug Works Better Than Serono's Rebif"..CLICK FOR MORE... Bloomberg.com:
Genzyme Corp. said its Campath drug was more effective in treating multiple sclerosis than Serono SA's Rebif, the second-best selling MS treatment worldwide.
MS patients had 75 percent fewer symptom relapses after two years of treatment with Campath than with Rebif, Cambridge, Massachusetts-based Genzyme said today in releasing interim results of a 334-patient study. The Genzyme-sponsored trial was suspended a year ago after a patient died from abnormal bleeding.
The results suggest that Campath may be an effective option for treating MS, a debilitating neurological disorder that affects more than 2.5 million people worldwide, analysts said. A plan by Genzyme to reduce the bleeding risk may help persuade regulators to allow a larger patient study needed to win U.S. regulatory approval, the company said
``Patients and physicians are willing to take on a certain amount of risk when you have new opportunities to combat this debilitating disease,'' Aaron Reames, an analyst with A.G. Edwards in Boston said today in an interview. ``This is definitely positive data.''
The U.S. Food and Drug Administration in June approved Biogen Idec Inc.' Tysabri MS drug, which had been withdrawn more than a year ago because of a fatal side effect. The FDA allowed Tysabri back on the market after the company set up procedures designed to have doctors closely monitor patients. Biogen's Avonex is the world's top-selling MS medicine.
Safety Data
Shares of Genzyme, based in Cambridge, Massachusetts, gained $1.80, or 2.7 percent, to $68.35 in Nasdaq Stock Market composite trading. They had fallen 6 percent this year before today. Serono fell 8 Swiss francs to 871.5 francs in Zurich.
Safety data from the trial will be presented later this month at the meeting of the European Committee for Treatment and Research in MS in Madrid. Final results from the three-year trial are due in a year from now.
MS robs people of muscle coordination and balance, and can lead to damaged vision and paralysis. The disease is caused when the body's immune system attacks myelin, the coating on nerve fibers. In severe MS, people have permanent symptoms, including partial or complete paralysis.
The Campath study compared the drug to Rebif in patients with a form of the disease, called relapsing/remitting MS, in which a flare-up of symptoms is followed by remission.
Genzyme said today it requested a meeting with the FDA to present the data and to address the next steps in the drug's development. The company has already received scientific advice from the European Medicines Agency for moving forward into the last of three stages of human tests needed for regulatory approval.....MORE
Genzyme Corp. said its Campath drug was more effective in treating multiple sclerosis than Serono SA's Rebif, the second-best selling MS treatment worldwide.
MS patients had 75 percent fewer symptom relapses after two years of treatment with Campath than with Rebif, Cambridge, Massachusetts-based Genzyme said today in releasing interim results of a 334-patient study. The Genzyme-sponsored trial was suspended a year ago after a patient died from abnormal bleeding.
The results suggest that Campath may be an effective option for treating MS, a debilitating neurological disorder that affects more than 2.5 million people worldwide, analysts said. A plan by Genzyme to reduce the bleeding risk may help persuade regulators to allow a larger patient study needed to win U.S. regulatory approval, the company said
``Patients and physicians are willing to take on a certain amount of risk when you have new opportunities to combat this debilitating disease,'' Aaron Reames, an analyst with A.G. Edwards in Boston said today in an interview. ``This is definitely positive data.''
The U.S. Food and Drug Administration in June approved Biogen Idec Inc.' Tysabri MS drug, which had been withdrawn more than a year ago because of a fatal side effect. The FDA allowed Tysabri back on the market after the company set up procedures designed to have doctors closely monitor patients. Biogen's Avonex is the world's top-selling MS medicine.
Safety Data
Shares of Genzyme, based in Cambridge, Massachusetts, gained $1.80, or 2.7 percent, to $68.35 in Nasdaq Stock Market composite trading. They had fallen 6 percent this year before today. Serono fell 8 Swiss francs to 871.5 francs in Zurich.
Safety data from the trial will be presented later this month at the meeting of the European Committee for Treatment and Research in MS in Madrid. Final results from the three-year trial are due in a year from now.
MS robs people of muscle coordination and balance, and can lead to damaged vision and paralysis. The disease is caused when the body's immune system attacks myelin, the coating on nerve fibers. In severe MS, people have permanent symptoms, including partial or complete paralysis.
The Campath study compared the drug to Rebif in patients with a form of the disease, called relapsing/remitting MS, in which a flare-up of symptoms is followed by remission.
Genzyme said today it requested a meeting with the FDA to present the data and to address the next steps in the drug's development. The company has already received scientific advice from the European Medicines Agency for moving forward into the last of three stages of human tests needed for regulatory approval.....MORE