Shares in Elan tumbled today in Dublin after it and its partner Biogen reported a third case of the brain disease PML in a patient taking their multiple sclerosis drug Tysabri.
In July, two cases of PML were reported in patients taking Tysabri, and the companies then decided to revise the drug's prescribing information.
The companies withdrew Tysabri from the market in February 2005 after three patients, two of whom died, contracted PML.
The drug returned to the market in 2006 with warnings after the US Food and Drug Administration decided MS patients willing to accept the risks should be able to have access to the drug's potential benefits.
The drug is given by injection once a month.
Just last week, Elan reported a 53% jump in third quarter revenues, driven by the continued growth of Tysabri. It said the drug generated in-market sales of $237m on a worldwide basis this quarter. That represented an increase of 154% over the $93.3m recorded the same time last year.
Elan said that Tysabri is fast approaching blockbuster status, defined in the industry as revenues exceeding $1 billion a year. At the end of September, about 35,500 patients were using Tysabri worldwide.
Tysabri also won US approval this year to treat adults with moderate to severe Crohn's disease who have had a poor response to, or can not take, other therapies.
Elan shares closed down 93 cent to €4.92 in Dublin this afternoon - a fall of 16%. They had slumped almost 49% in earlier trade.