Tuesday, December 19, 2006

Warning Given On Drug's Use To Treat Lupus

New York Times Full Feed - Dec. 19, 2006

Biogen Idec and Genentech have warned doctors of two deaths among patients receiving the cancer drug Rituxan as a treatment for the autoimmune disorder lupus.

The medicine, used to treat patients with non-Hodgkin's lymphoma and rheumatoid arthritis, is not approved as a therapy for lupus, Biogen, based in Cambridge, Mass., said yesterday in a regulatory filing. The patients developed a rare brain infection called progressive multifocal leukoencephalopathy, or P.M.L., the companies said.

Rituxan's prescribing information already includes a warning about P.M.L. for cancer patients taking the drug. The infection is also a risk of Biogen's multiple sclerosis drug Tysabri, which was withdrawn from the market in 2005 because of three cases of the disease, which has no treatment and is usually fatal. It was reintroduced last July after Biogen adopted a new safety program for the drug. The companies are also testing Rituxan as a multiple sclerosis treatment.

''This might make it more challenging to develop Rituxan in M.S. and lupus,'' Eric Schmidt, an analyst with Cowen & Company in New York, said in a telephone interview. ''Even though we can't necessarily link this to Rituxan, it's an unfortunate circumstance.''

The Food and Drug Administration posted a public health advisory on its Web site about the two deaths.

Biogen shares, after closing at $50.23 on Nasdaq yesterday, fell $2.69, or 5.3 percent, to $47.54 in after-market trading. Genentech shares, after closing at $80.96 on the New York Stock Exchange, fell $1.46 in after-hours trading, or 1.5 percent, to $79.50. Genentech, based in South San Francisco, Calif., markets the drug with Biogen in the United States. Roche Holding, based in Basel, Switzerland, sells Rituxan in Europe under the name Mabthera.

Since its approval in 1997, Rituxan has been linked to 23 cases of P.M.L. among patients with non-Hodgkin's lymphoma, a cancer of the lymphatic system, said Tim Hunt, a Biogen spokesman.

The infection is a known risk in patients whose immune systems are suppressed because of their diseases or the drugs they are taking, the companies said.