Trading in Elan shares to be suspended for two days
Neuroscience-based biotechnology company Elan has announced the suspension of trading of its shares with effect from March 7, 2006 for up to two days.
Neuroscience-based biotechnology company Elan has announced the suspension of trading of its shares with effect from March 7, 2006 for up to two days.
The suspension of trading applies to the Irish, UK and US Stock Exchanges and is due to the scheduled US FDA Advisory Committee meeting to review Tysabri (natalizumab). Trading is expected to resume once the Advisory Committee meeting has finished.
Tysabri had been suspended voluntarily by Elan and Biogen Idec from the US market and all ongoing clinical trials on the basis of reports of progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal demyelinating disease of the central nervous system. The two companies completed a comprehensive safety evaluation of more than 3,000 Tysabri patients in collaboration with leading experts in PML and multiple sclerosis. The results of the safety evaluation yielded no new confirmed cases of PML beyond the three previously reported.
Last month the FDA informed the companies that it had removed the hold on clinical trial dosing of Tysabri in MS in the US, and an open label, multi-centre safety extension study of Tysabri monotherapy in the US and internationally was expected to resume within weeks.
The review in March follows the submission of a supplemental Biologics License Application to the FDA last September, as a result of which the drug was granted Priority Review status.