Tysabri was taken off the market after being linked to a potentially life-threatening brain illness called progressive multifocal leukoencephalopathy. Elan and its marketing partner
(BIIB - Get Report)
recently completed a safety evaluation of more than 3,000 Tysabri patients in collaboration with leading experts on PML and MS. The results turned up no new confirmed cases of PML beyond the three that have been already reported.
Excluding potential revenue from Tysabri and the impact of share-based compensation, Elan expects this year's revenue to exceed $500 million, with product revenue accounting for more than 90% of the total.
Biogen and Elan have submitted a new application to the Food and Drug Administration in an effort to get Tysabri cleared again. The application has been designated for priority review, a status given to products seen as significant and that could address an unmet medical need. An FDA advisory committee plans to review the resubmission on March 7.
Elan also said it recently received a subpoena from the Justice Department and the Department of Health and Human Services asking for documents and materials mainly related to its marketing for Zonegran. The company said it will cooperate with the investigation. Elan sold its interests in Zonegran in North America and Europe to Japan's
in April 2004.