Genentech Withdraws Psoriasis Drug Linked to Brain Infections
Genentech, the biotechnology company acquired last month by Swiss drugmaker Roche Holding AG, has told doctors not to write prescriptions for new patients as part of a phased withdrawal of Raptiva to be completed by June 8, the South San Francisco-based company said yesterday in a statement. About 2,000 U.S. patients may be taking Raptiva, Genentech said
The decision to withdraw the drug, which generated $108 million in U.S. sales for Genentech last year, came after three patients were diagnosed since October with the brain infection progressive multifocal leukoencephalopathy, two of whom died, said Tara Cooper, a Genentech spokeswoman. The risk of PML, which causes irreversible brain damage, outweighed Raptivas benefits in controlling psoriasis, the company concluded.
“We said, and the Food and Drug Administration agreed, that Raptiva likely causes PML,” said Ivor Caro, Genentechs senior medical director for dermatology, in a telephone interview. What tipped the balance was that Genentech could neither predict which patients were likely to develop PML, nor come up with a strategy to lessen that risk, he said.
“It was the clinical science perspective, not how much Raptiva was being sold,” Caro said.
$125 Million Charge
The withdrawal will result in a one-time charge of about $125 million, the company said.
Raptiva, approved in 2003, was designed to suppress the abnormal immune response that triggers psoriasis, a painful, scaly rash that afflicts about 7.5 million Americans, according to the National Psoriasis Foundation. Sales never took off as other anti-inflammatory medicines, including Amgen Inc.s Enbrel, Johnson & Johnsons Remicade and Abbott Laboratories Humira, entered the psoriasis market.
“Most people could see this coming,” said Eric Schmidt, a biotechnology analyst with Cowen & Co. in New York in a telephone interview. ” We knew this drug had a severe side- effect profile, and its efficacy isnt that good.”
A fourth patient on Raptiva, who developed worsening neurologic symptoms, also died of unknown causes, the company said.
At least four other drugs have been linked to PML risk. They include Roches Cellcept, used to prevent transplant rejections; Biogen Idec Inc. and Genentechs cancer drug Rituxan; Biogens multiple sclerosis treatment Tysabri and Genzyme Corp .s leukemia drug Campath.
No Other Withdrawals
“I see zero impact” he said. “Rituxan treats cancer. Tysabri, multiple sclerosis. The risk benefit for using Rituxan and Tysabri for their respective indications is very favorable. Thats different from the profile for Raptiva, which Genentech decided is borderline.”
PML occurs when a common germ, called JC virus, mutates, then evades the bodys immune defenses and penetrates the brain. People with suppressed immune systems are most at risk for PML.
Biogen, based in Cambridge, Massachusetts, has been testing a malaria drug and a blood-cleansing therapy as treatments for the deadly brain infection.
Biogens multiple sclerosis drug Tysabri was pulled from the market in 2005 after three PML cases were reported. It was reintroduced a year later when U.S. regulators said the medications effectiveness, twice that of other MS drugs, outweighed its risks. Five cases of PML in Tysabri users have been reported since July.
Genentechs Caro said the company contemplates no similar withdrawal action for its Rituxan drug, which is used to treat non-Hodgkins lymphoma.