Shares in Elan spike on Tysabri decision

Shares in Elan soared in Dublin yesterday as the market digested the impact of the overnight decision by by a US regulatory review panel to recommend a return of its key product, the MS drug Tysabri, to market.

The stock was up over 26 per cent at one point in heavy trade before coming back to close on €13, a gain of 15 per cent.

Analysts in Dublin were bullish about the company's prospects after the recommendation from the independent advisory panel appointed by the US Food and Drug Administration (FDA) that Tysabri be authorised for sale again.

The FDA is due to make a decision by the end of the month and, while not obliged to follow the recommendation, has indicated that it will do so.

"The committee's decisions are a strong positive for Elan and give us increased confidence in our existing model which sees peak sales of $1.9 billion by 2009," said Goodbody analyst Ian Hunter.

He said the panel's decision to allow Tysabri as a treatment in patients who had not yet failed with other therapies and for all patients with "relapsing remitting" MS were more than some observers had hoped for.

Davy's Jack Gorman said the proposal that Tysabri become only the second prescription drug to be allowed back on sale in the US after being withdrawn for safety reasons was "excellent news".

He said he expected that up to 80,000 patients would eventually opt for the treatment, which has been shown in trials to be twice as effective as other MS therapies currently available.

Dr Lars Ekman, head of global research at Elan, said the company was "very pleased" at the outcome of the two-day review hearing. "This is very good news for MS patients and also for the company."

Dr Ekman said the testimonies from patients who had had the chance to use the drug had played a "very significant part" in the effort to have the drug returned to market.

The requirement for a strict patient registry, which will make dispensing more restrictive than originally planned, should not adversely affect the success of the drug, he said.

Dr Ekman also said the company expected the drug to become available for European patients in the second half of the year. European approval was frozen at the same time as the drug was withdrawn from sale in the US last year.