Analysis: Elan says its Crohn's disease drug impresses regulatorsand holds out the prospect of early European approval, writes Dominic Coyle

Regulators have been impressed with data from Elan's clinical trials of Antegren for Crohn's disease despite the fact that the company missed a critical target in the trial, shareholders heard yesterday.

Elan's research and development chief, Dr Lars Ekman, said the company had held talks with regulators in both the United States and Europe following the setback in the Crohn's trial.

"They were impressed," he said, adding that the European authorities had indicated they did not require any further data but would want to further analyse the current figures.

Elan is currently carrying out maintenance trials for Crohn's sufferers using Antegren and expected results in the first quarter of next year. Dr Ekman said this would be passed to the authorities.

His comments hold out the prospect of a release of Antegren as a treatment for Crohn's in Europe ahead of any US approval.

The US Food and Drugs Administration (FDA) is also awaiting data from the maintenance trial before deciding on its next move.

However, the company announced yesterday that it was launching a further trial with its partner Biogen to provide more data that it expects the FDA will require.

Dr Ekman also said information on the efficacy of Antegren as a treatment for multiple sclerosis could be available by the middle of next year.

He held out the prospect of approval for the treatment being fast-tracked if the phase three trials produced results as spectacular as earlier indications.

The R&D director said the company was investigating the possibility of Antegren having potential as a treatment for a range of other auto-immune conditions such as rheumatoid arthritis, psoriasis, ulcerative colitis and even organ transplant.

"However, we will take this one step at a time," he said.

He also said the group was making good progress in treatments it is developing to tackle Alzheimer's disease.

Chief executive Mr Kelly Martin acknowledged that the company was "reaching a point in our life cycle where innovation and ideas need to be got to the market".

"We have made enormous progress and are ever so close to production, but we have to show the market that we can take the science to the market," he said, adding that the company's development of Prialt indicated its ability to deliver on its potential.