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Group Leader: Elizabeth Peterson  873-0818
 

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Elan, Biogen Idec Shares Fall in Late Trading on Third Infection
Related to Tysabri

NEW YORK (AP) -- Irish biotech firm Elan Corp. and partner Biogen Idec Inc. said Wednesday that their ongoing safety evaluation of multiple sclerosis drug Tysabri has turned up a second fatality, involving a patient in a Crohn's disease trial who died in December 2003.

Elan shares fell 12 cents to close at $6.98 on the New York Stock Exchange, but then plunged 38.4 percent to $4.30 in the after-market. Biogen shares rose 66 cents to close at $38.35 on the Nasdaq, but then dropped 8.8 percent to $34.99 in after-hours activity.

The patient was previously diagnosed as having a case of malignant astrocytoma, but that diagnosis is now being reassessed for possible progressive multifocal leukoencephalopathy, or PML -- a rare and often fatal disease of the central nervous system.

On Feb. 28, the companies announced that they suspended marketing of Tysabri in multiple sclerosis and dosing in all clinical trials based on two previously reported cases of PML. Elan and Cambridge, Mass.-based Biogen Idec then launched an additional safety evaluation of Tysabri clinical trial patients, which resulted in the patient's diagnosis being reassessed.

The deceased patient had received 8 doses of Tysabri over an 18-month period and prior medication history included multiple courses of immunosuppressant agents.

Elan and Biogen Idec's comprehensive safety evaluation concerning Tysabri and any possible link to PML is ongoing. The companies are reviewing clinical trial data, working with investigators to evaluate the about 3,000 patients in multiple sclerosis, Crohn's disease and rheumatoid arthritis trials, and working with PML and neurology experts.

The companies said that they will discuss the results of this safety evaluation with regulatory agencies to determine possible re-initiation of dosing in clinical trials and future commercial
availability.