Elan reports positive MS drug trial results
By Michael Smith
DUBLIN (Reuters) – Elan Corp. Plc said on Friday the latest
trials of its multiple sclerosis drug Tysabri showed
significant positive results in patients, sending its shares
“The Tysabri study data show not only significant
reductions in relapses and disability, but also suggest
improved quality of life. This is very encouraging,” the
company said in a statement.
Elan and drugmaker Biogen Idec faced a fresh delay in
getting Tysabri back to the market last month after U.S.
regulators extended their review of the drug by three months,
until June 28.
Tysabri was pulled abruptly last year following concerns
about a link with a life-threatening side effect, but an
independent advisory panel recommended that multiple sclerosis
sufferers be allowed to take the drug, subject to certain risk
Elan shares rose 4.0 percent to 12.06 euros by 0840 GMT
after releasing the results of its Phase III trials of the
drug, which were presented at the annual meeting of the
American Academy of Neurology in San Diego. The DJ Stoxx
European healthcare index was down 0.2 percent.
“These additional data further underpin Tysabri’s superior
efficacy profile to currently marketed MS drugs,” Davy
stockbrokers said in a note to clients.
Davy said its earnings forecasts for Elan assumed it would
launch the drug by mid-2006.
Elan aims to launch the drug within weeks of FDA approval,
which it expects to receive following the extended review.
Elan said this was the first time it had observed positive
findings on so-called quality of life measures in a Phase III
Multiple sclerosis causes progressive disability that can
include blurred vision, weakness, poor muscle coordination and
loss of memory and mental function as nerves lose their
The company said patients treated with the drug had a
reduction in the risk of visual decline and a reduction in the
risk of the rate of disability.
Biogen and Elan suspended Tysabri sales in February 2005
after three patients developed an infection called progressive
multifocal leukoencephalopathy, or PML. Two of them died.
But the advisory panel said that, despite potential risks,
Tysabri should be available as an option for MS sufferers, many
of whom they said did not find relief with current medicines.
(Additional reporting by Pete Harrison in London)