THE makers of the multiple sclerosis treatment, Tysabri — Irish drug firm, Elan and its US counterpart, Biogen Idec — have reiterated confidence in global patient numbers for the product rising from 35,500 to 100,000 in the next two years, even in the light of another death occurring among users.
Tysabri was originally withdrawn from the market in early 2005 after three users developed the rare brain disease, PML — two of whom actually died. Since Tysabri’s return to global markets in 2006, four users have contracted the disease. Two of them have since recovered, while the latest was only reported this week. The latest fatal case — a female MS sufferer based in the US — contracted the disease last October.
Jose Juves, director of public affairs for Biogen Idec International, said yesterday that Tysabri — which is also used to treat Crohn’s Disease in the US — is not likely to be removed from the market by the drug authorities in either North America or Europe as a result of the latest news. He also reiterated Biogen and Elan’s previously held belief that the risks of contracting PML from using Tysabri are low. The drug does already carry a full warning of side effect risks — including the possibility of PML — on its labelling across the world.
"Before PML was identified as a potential, if rare, side effect of using Tysabri, the disease was characterised as almost always fatal. Early detection and corrective therapy has shown, however, that this is not the case" Ian Hunter, an analyst with Goodbody Stockbrokers said.
Indeed, the newest case of PML — announced earlier this week — is said to be "only" a mild strain of the disease. Nevertheless, Elan’s share price in Dublin dipped by 24c — or 5.39% — yesterday to €4.21.
However, of better news for Elan was the announcement that it could be in line for high level royalty revenues after US pharmaceutical firm, AstraZeneca said that it had entered Phase 3 clinical trials for a treatment for paediatric asthma, which avails of technology from Elan Drug Technology.
a d v e r t i s e m e n t
This appeared in the printed version of the Irish Examiner Saturday, December 20, 2008
