Novartis Drug Heralds Era Of New Multiple Sclerosis Therapies
In Seattle this week, the two companies will present results from late-stage trials of two oral drugs. If the products go on to win regulatory clearance, patients for the first time will be able to take pills, rather than shots or transfusions, to slow the muscle-wasting condition. Five more pills and two new infusion therapies may join the now $7.5 billion a year MS market by 2014, according to the National Multiple Sclerosis Society in New York.
Progress against MS is coming on three fronts, said John Richert, a doctor who leads research at the society. The new drugs may reduce the frequent relapses most patients face. Improved detection may allow earlier treatment before symptoms emerge. Stem-cell therapies now being tested may go even further, reversing disability in patients with advanced disease.
“In terms of stopping disease activity, there are more therapies coming onstream than ever before and many of these also appear to be more potent,” Richert said in a telephone interview. “While the whole idea of repairing the nervous system really seemed like science fiction five to six years ago, advances in the last year suggest this may well be within our grasp.”
First described 140 years ago, multiple sclerosis causes the body to attack itself through the immune system. Rogue immune cells travel to the brain and spinal cord and enter the nervous system. There the cells assault and destroy myelin, the fatty substance that surrounds nerve-cell fibers. That interferes with the nerve cells ability to transmit electrical impulses and move muscles.
Taking a Fall
MS generally starts in early adulthood, disrupting peoples coordination and balance and sometimes leading to damaged vision and paralysis. For Rhonda McHenry, a fall in 1994 while chasing her then 9-month-old son, and the resulting nerve pain, led to an MS diagnosis.
McHenry, now 44, was diagnosed with the “relapsing- remitting” form of MS that makes symptoms flare and recede and that 85 percent of patients have initially, according to the MS Society.
In one way, she was fortunate. Around the time of her diagnosis, three new drugs made from proteins called beta interferons were approved to prevent MS relapses.
The new treatments included Avonex, made by Biogen Idec Inc. of Cambridge, Massachusetts; Betaferon, made by Bayer AG of Levrkusen, Germany; and Copaxone, a product from Teva Pharmaceutical Industries Ltd., of Petah Tikva, Israel.
Inhibit Immune Response
These products, along with Rebif, made by Merck KGaA, of Darmstadt, Germany, inhibit the overactive immune response found in MS, reducing damage to nerves and slowing disability, Richert said. Rebif was approved by the U.S. Food and Drug Administration in 2002.
As researchers have learned more about how the immune system attacks nerves, they have been able to design drugs that interfere with that process, Richert said.
Blocks Cell Movement
The newest MS treatment on the market, Biogens Tysabri, blocks the movement of immune cells from the bloodstream into the nervous system.
The experimental Novartis drug FTY720 disrupts the movement of immune cells at an earlier stage than Tysabri, keeping them from leaving lymph nodes and entering the bloodstream, according to Richert.
German Merck is attempting to turn a cancer drug, cladribine, into an MS medicine because it suppresses the immune system, blunting its attack on nerve cells. The product was approved to treat leukemia more than a decade ago.
Novartis, based in Basel, Switzerland, and Merck will release results this week at a Seattle meeting of the American Academy of Neurology, a professional association based in St. Paul, Minnesota. Preliminary findings already released by both companies suggest that the drugs limit relapses.
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