Merck KGaA Pill Cuts MS Relapse Risk in Half, With Side Effects
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By Naomi Kresge and Rob Waters
April 29 (Bloomberg) -- Merck KGaA’s multiple sclerosis pill cladribine cut patients’ risk of relapsing in half even as it depleted white blood cells that protect the body from infection in some, a study showed.
Patients who took the German drugmaker’s pill were also less likely to see the neurological disease progress and more likely not to relapse at all than those on a placebo, according to results of a two-year clinical trial presented today at the American Academy of Neurology conference in Seattle. Lower counts of white blood cells, or lymphocytes, were found in as many as 31 percent of those getting the pill, researchers said.
Merck, based in Darmstadt, said it would seek U.S. and European regulatory approval mid-year as it races Switzerland’s Novartis AG to market the first pill for multiple sclerosis. The results suggest doctors and patients will have to balance the benefit of convenient treatment against infection risk, said Lily Jung, medical director of the neurology clinic at the Swedish Neuroscience Institute in Seattle.
“There are a lot of patients who need to be on medications but aren’t because they don’t want to take shots, and that’s who I would offer it to, said Jung in an interview today in Seattle. “But for my patients who are stable and doing well clinically I wouldn’t recommend they switch.”
The study was funded by Merck Serono SA in Geneva, Switzerland, an affiliate of Merck KGaA. The German company is not affiliated with U.S. drugmaker Merck & Co. Jung has accepted speaking or consulting fees in the past from German Merck.
White Blood Cells Lower
One side effect seen was lymphopenia, a condition in which disease-fighting white blood cells are abnormally low. It occurred in 31 percent of patients on a high dose of cladribine and 22 percent of those on a low dose, compared with 2 percent of the group that didn’t take the medicine at all, Merck said in slides prepared for presentation at the Seattle meeting.
Patients on cladribine had a “similar” rate of infections as those who took placebo, Merck said in a statement. Almost 2 percent of patients taking cladribine had herpes zoster skin infections, which were not seen in any of the placebo patients. Five people were diagnosed with cancer, including one case of choriocarcinoma, a cancer of the placenta, in a woman who became pregnant six months after she finished the study.
Merck had previously reported four cases of cancer among people in the study.
Five to 10 Years
“They’re going to need long-term follow-up,” said Jung, whose patients participated in the study. “The question is what will happen in five to 10 years.”
The results will encourage people with MS who are not currently being treated with injectable drugs to start getting therapy, said Bruno Musch, Merck’s vice president of global clinical development, in an interview today in Seattle.
“Historically the approach has been wait and see,” he said. “Some 82,000 patients in the U.S. don’t receive any treatment. Now doctors are switching to more aggressive treatment.” The availability of a pill will accelerate that trend, he said.
Patients on a low dose of cladribine had 58 percent fewer relapses than those on placebo, Merck said, confirming data it initially released in January. Patients in the higher-dose group experienced 55 percent fewer annualized relapses.
Both groups had fewer brain lesions than those in the placebo group and showed more than 30 percent reduction in the risk of disability progressing, compared with placebo, Merck said.
Relapse Risk Halved
The results are equivalent to cutting a patient’s relative risk of relapse in half, Musch said. The pill is meant for patients with the “relapsing-remitting” form of MS, in which symptoms flare and recede. Some 85 percent of patients are initially diagnosed with relapsing-remitting MS, according to the Multiple Sclerosis Society.
The FDA is likely to require the company to continue to study the safety of the treatment after it’s approved, Musch said.
The most common side effects are upper respiratory tract infections and nasal infections, Merck said.
“There’s a reason you need your lymphocytes -- to fight infection,” Jung said. “If you were an MS patient taking cladribine, you’d be very worried about swine flu right now because you’d be less able to fight it off,” Jung said.
Competition
How doctors interpret the side effects may determine if and when the products will take revenue from existing multiple sclerosis therapies by Bayer AG, Biogen Idec Inc. and Teva Pharmaceutical Industries Ltd., said Jack Scannell, a London- based analyst with Sanford C. Bernstein Ltd., before the results were released.
“This could easily be a blockbuster if things go for them,” Scannell said, referring to medicines with more than $1 billion in sales each year. Safety concerns that would restrict the drug to patients with more serious forms of the disease could hold Merck’s pill to a “middle of the line” drug, he said.
To contact the reporter on this story: Naomi Kresge in Geneva at nkresge@bloomberg.net
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