Dashed hopes for Elan
Analysts think it now unlikely that Elan/ Biogen Idec's MS drug, Tysabri (natalizumab), will be back on the market soon, after a third case of progressive multifocal leukoencephalopathy (PML), was diagnosed in a patient in an open label Crohn's disease clinical trial. This follows two previously reported cases of PML in multiple sclerosis clinical trials.
Analysts think it now unlikely that Elan/ Biogen Idec's MS drug, Tysabri (natalizumab), will be back on the market soon, after a third case of progressive multifocal leukoencephalopathy (PML), was diagnosed in a patient in an open label Crohn's disease clinical trial. This follows two previously reported cases of PML in multiple sclerosis clinical trials.
Elan and Biogen Idec initiated an additional comprehensive safety evaluation of Tysabri clinical trial patients, and in the course of this safety review, the companies identified a case warranting reassessment in an open label Crohn's disease clinical trial. This case was subsequently assessed as PML, a rare and frequently fatal, demyelinating disease of the central nervous system.
On February 28, 2005, the companies announced that they had suspended marketing of Tysabri in multiple sclerosis and dosing in all clinical trials based on two previously reported cases of PML.
The development comes at a difficult time for the Irish company, and analysts believe it will now have to initiate a cost-cutting programme as Elan has more than $1bn of debt to repay in 2008, and was relying on revenues from Tysabri to bring it back to profitability.
There is speculation it will look at selling off its two antibacterial medicines, Azactam and Maxipine, valued at around $350m (£185m), or sell its drug delivery business.
'We are reviewing cost structures as a result of recent events and will manage cash burn through aggressive cost control, both as it affects Tysabri and the rest of the business,' said a spokesman.
Tysabri had shown better results in MS patients than other drugs on the market, and had also been tried in people with Crohn's disease and rheumatoid arthritis. It works by suppressing the immune system in the brain, which is over-active in MS. PML is often seen in patients with Aids, where the immune system is suppressed.
Elan and its partner Biogen, a US drugs firm, are studying the 3,000 patients who have taken the drug to find whether there are more cases of PML.