Tuesday, October 24, 2006

US doctors still wary of Tysabri - survey

October 24, 2006 09:14

US doctors are proving more wary than many had expected about prescribing Elan's multiple sclerosis drug Tysabri, which was relaunched in July after being suspended because of safety concerns.

Over the past month or so, analysts have drawn down their 2006 sales forecasts as it becomes clear that doctors wary of the risk of the rare but potentially fatal brain disease PML are reserving the drug as a treatment of last resort.

The drug, which is made by Elan and its US Biogen Idec, had been expected by some analysts to generate sales this year of more than $100m, but those figures have dropped dramatically.

Ian Hunter, an analyst at Goodbody stockbrokers, said yesterday that he has cut his full-year Tysabri forecast to $25.7m from $78m, partly because of continuing safety concerns and the complexity of reimbursement systems in Europe.

A survey of 63 US neurologists indicates that in 2006 Tysabri will be used in less than 1% of multiple sclerosis patients - translating into revenue of under $30m.

Since July, only 47 of more than 8,500 patients treated by US physicians surveyed had used Tysabri, even though more than 700 patients had discussed using it, according to the report. And more than 75% of the patients who had used Tysabri prior to its 2005 suspension have decided not to use it since its reintroduction, the survey showed.

In taking the rare decision to allow a withdrawn drug back onto the market, the US Food and Drug Administration was partially influenced by calls from patients who said they were willing to take the risk of contracting progressive multifocal leukoencephalopathy, or PML, because of the potential benefits of the drug.

Tysabri's ultimate sales potential will depend, to an acute degree, on whether there are any more cases of PML, analysts say. Most of the respondents to the survey said they would stop using Tysabri altogether if two new PML-related deaths were associated with Tysabri.

Elan is due to report its third quarter results tomorrow.