Pharmaceutical company Biogen Idec affirmed its outlook for 2006 earnings as it awaits word from the US Food and Drug Administration on whether its withdrawn multiple sclerosis drug Tysabri can be returned to the market. The drug was co-developed with Elan.
The company still expects to earn $1.95 to $2.10 per share this year on an adjusted basis, which assumes a mid-year relaunch of the drug, Chief Executive Jim Mullen said at an investor conference yesterday.
Mullen said he expects the FDA to call for a special advisory panel to review the company's application to resume sales of Tysabri, although a date has not been set. The FDA is slated to make a decision on the drug by late March.
Elan and Biogen pulled Tysabri nearly a year ago after it was associated with a potentially fatal brain disorder. Industry analysts had hailed the drug as a potential blockbuster when it was launched in November 2004 because clinical data suggested it was more effective than existing MS treatments.
Mullen said Biogen's latest regulatory application includes longer-term data showing that the drug prevents progression of disability. Three cases of progressive multifocal leukoencephalopathy (PML), two of which were fatal, have been traced to the drug.
Mullen said Biogen is working with the FDA on how to educate neurologists about the drug's risks.
