Shares in Elan gained 4 per cent in Dublin yesterday after the company said it would seek European regulatory approval for the use of its drug, Antegren, in the treatment of Crohn's disease.
Elan and Biogen Idec, the United State's company with whom it is developing the drug, said they expected to submit the filing to the European Medicines Agency in the fourth quarter of 2004.
The announcement that they had decided to file for approval, based on the results of recent trials of the drug, lifted the shares by 7 per cent to a high of €20 in morning trade before they gave up some ground later in the day.
In Dublin, they closed 76 cents higher at €19.44 while in New York, their main market, they were down 72 cents to $21.90.
"This filing timeline is earlier than we had assumed for the product and is likely to see approval of the drug in the second half of 2005, which again is earlier than our forecast timeline for a first-half 2006 launch of Antegren for Crohn's disease in Europe," said Mr David Marshall, analyst at NCB Stockbrokers.
Others were more cautious in their welcome, however.
Mr Peter Frawley, analyst at Merrion Stockbrokers, described the announcement as "an incremental positive" for Elan.
"It brings it forward but the major opportunity is in getting approval in the US and the key indication for the drug is multiple sclerosis (MS) rather than Crohn's," he said.
Elan and Biogen are still in discussions with the US Food and Drug Administration (FDA) in relation to the timing of the filing in the US, the more important market for the drug.
But it is thought the FDA will want to see more data from a second induction trial currently underway before accepting a filing.
Analysts estimate that the US market for Crohn's disease, a disorder of the bowel, is worth around $700 million (€583 million) compared to just $100 million in Europe.
At a conference on digestive diseases in New Orleans yesterday, Elan presented results from its Phase III maintenance trial of Antegren for the treatment of Crohn's disease.
Analysts said most of the data had been in the public domain since the beginning of May, however.
Elan also said yesterday that it had completed the sale of another drug, Frova, to British biotech firm Vernalis.
