Elan seeks early US licence for MS drug

Elan and its development partner, Biogen Idec, could be licensed within a year to sell a multiple sclerosis (MS) treatment with…

Elan and its development partner, Biogen Idec, could be licensed within a year to sell a multiple sclerosis (MS) treatment with significant potential. Barry O'Halloran reports.

The companies announced that they have applied to the US Food and Drug Administration (FDA) for a licence to sell the MS treatment, Antegren, in the US. They are expected to seek approval in Europe by the end of this quarter.

They made the application after meeting early success in clinical trials. As Antegren is a naturally occurring enzyme rather than an artificially produced chemical, the pair applied to the FDA for a biologics licence, which is the drug licence equivalent for biotechnology products.

Merrion Capital analyst, Mr Peter Frawley, told The Irish Times last night that the FDA was expected to grant this in the first half of 2005.

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Mr Frawley predicted that the market for Antegren could be worth up to $4 billion (€3.31 billion) within four years of it being placed on the market. He estimated that there were at least 100,000 MS sufferers in the US who would be likely to avail of the treatment immediately.

He added that it could generate sales in its first year of $200 million. "But they would ramp up fairly quickly after that," Mr Frawley said. Elan will split the revenues 50-50 with Biogen.

Elan closed up 8 cents at €18.05 in Dublin last night and rose $1.70 to $23.01 in New York.