MS drug withdrawn after patient dies

IRISH drugs group Elan and its partner Biogen have withdrawn sales of its multiple sclerosis drugs after a patient died from the rare and often fatal central nervous system disease, sending shares of both drug makers tumbling.

A second patient is also in danger.

One patient was 38 months on the drug and the other 27.

Elan chief executive Kelly Martin said the drug was withdrawn following consultation with the Federal Drugs Administration in the US.

“It shows we are following the highest ethical standards and practices,” he said.

The death occurred while the patient was using the alleged wonder drug Tysabri in conjunction with a Biogen prescription that has been on the market for some time.

In another dramatic day for Elan, the clinical trials of the drug have been suspended. Elan’s shares fell nearly 70% in Dublin, wiping over 3% off the value of the Irish stock market.

Shares plunged in Dublin from €20.30 to €6.37 following the shock news which wiped about €5.5bn off the market value of the group.

In the US, Biogen Idec shares tumbled 40% to $26.92, dragging the American Stock Exchange biotechnology index down 4.2%.

About 2,600 people are in clinical trials for the product in the United States, while a further 3,000 are taking the drug on a commercial basis.

Approved only last November, Tysabri was expected to become the world’s leading multiple sclerosis treatment.

Analysts also saw it as the key to Elan’s revival while at the same time providing fresh dynamism for Biogen Idec, whose existing multiple sclerosis drug, Avonex, faced increased competition.

In New York, several analysts warned that this was another strong blow to Elan following on the 2001 investigation by the Security and Exchange Commission into its accounting practices. If the drug comes back it will have a huge safety cloud over it and will require a set of investigations of all patients pre-and post marketing approval,” said Geoff Porges, analyst with Bernstein & Company.

Bloxham Stockbrokers head of research Kevin McConnell says it will take a few weeks to make a final judgment.

“It may well be that it is dead in the water, it’s just too soon to say at this stage,” he said. This latest suspension follows Merck’s withdrawal of its blockbuster pain drug Vioxx after a study showed it doubled heart attack and stroke risk compared with placebo in patients taking the drug for more than 18 months.

Biogen was the top performing stock over a 10-year period, according to a report in Monday’s Wall Street Journal.

Patients mentioned in yesterday’s withdrawal statement were on Tysabri and Avonex. To date, the companies said they have no reports of PML in patients receiving separate doses of Tysabri or Avonex.