BIOGEN IDEC AND ELAN ANNOUNCE RE-INITIATION OF TYSABRI® CLINICAL TRIAL DOSING IN MS
Biogen Idec - MORE
"Cambridge, MA and Dublin, Ireland - March 29, 2006 - Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc. (NYSE: ELN) announced today that they have enrolled and dosed the first patients in the TYSABRI® (natalizumab) monotherapy safety extension study program in multiple sclerosis (MS). Patients who previously participated in the Phase III MS trials and subsequent safety evaluation are eligible to be screened for entry in this open label multi-center study. Sites throughout Europe, the United States, Canada, Australia, New Zealand and Israel are expected to enroll patients. This safety extension study is being conducted under a U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) application in the U.S. and similar investigational approvals internationally.
Biogen Idec and Elan had previously voluntarily suspended TYSABRI from the U.S. market and dosing in all ongoing clinical trials based on reports of progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal, demyelinating disease of the central nervous system. Biogen Idec and Elan completed a comprehensive safety evaluation of more than 3,000 TYSABRI patients in collaboration with leading experts in PML and MS. The results of the safety evaluation yielded no new confirmed cases of PML beyond the three previously reported.
On March 8, 2006, the Peripheral and Central Nervous System Drugs Advisory Committee of the FDA voted unanimously to recommend reintroduction of TYSABRI as a treatment for relapsing forms of MS. The companies anticipate action by the FDA regarding the reintroduction of TYSABRI in the U.S. on or before June 28, 2006. The companies' application for approval of TYSABRI as a treatment for MS is also under review with the European Medicines Agency."
