Warning on Genentech-Biogen drug - Two lupus patients succumb to rare brain infection after taking Rituxan

[Guest guest]

Warning on Genentech-Biogen drug

Two lupus patients succumb to rare brain infection after taking Rituxan,

regulator reports, sending companies' shares lower in after-hours trading.

December 18 2006: 7:21 PM EST

http://money.cnn.com/2006/12/18/news/companies/bc.genentech.rituxan.reut/index.h\

tm?section=money_email_alerts

WASHINGTON (Reuters) -- Two lupus patients died from a rare brain infection

after taking the Genentech and Biogen Idec drug Rituxan, U.S. health

officials said in an advisory issued Monday.

Shares of Genentech slipped over 2 percent in after-hours trading, while

Biogen stock tumbled over 5 percent.

Rituxan, authorized for lymphoma and rheumatoid arthritis, is not approved

for treating lupus but doctors sometimes prescribe it for that use, the Food

and Drug Administration said in a notice posted on its Web site.

Both patients died from a brain infection called progressive multifocal

leukoencephalopathy, or PML, the FDA said. The agency urged doctors to

discuss the chances of PML with Rituxan patients, saying there is no known

treatment.

Rituxan's prescribing instructions already include information about reports

of several types of viral infections, including PML, that became active

again or worsened in cancer patients taking Rituxan.

" FDA is working to gather more information about Rituxan and PML and to

strengthen the warnings about PML in the Rituxan product label, " the agency

said.

Biogen said it and Genentech issued a letter to doctors about the patients

with lupus, an autoimmune disease.

Genentech spokeswoman Debra worth said clinical trials of Rituxan

were ongoing for lupus and other conditions. The two lupus patients who died

were not enrolled in a clinical trial, she said.