Tysabri-Important Info

[Guest guest]

I know we don't discuss traditional drugs here, but from memory there

at least a couple of people on Tysabri in the group and I can't

remember who, so I thought I'd better send this to the group if that

is OK. Apologies if not:

Two fresh cases of brain infection linked to Biogen/Elan's Tysabri

<http://www.pharmatimes.com/WorldNews/article.aspx?id=14052 & src=EWorldNews>

Biogen Idec and Elan Corp have suffered a stock slide in after-hours

trading after the firms revealed two new cases of progressive multifocal

leukoencephalopathy, in MS patients being treated with Tysabri, the

brain infection that led to the drug being withdrawn in 2005

arrowread more

<http://www.pharmatimes.com/WorldNews/article.aspx?id=14052 & src=EWorldNews>

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Two fresh cases of brain infection linked to Biogen/Elan's Tysabri

01 August 2008

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Biogen Idec and Elan Corp have suffered a stock slide in after-hours

trading after the firms revealed two new cases of progressive multifocal

leukoencephalopathy, in multiple sclerosis patients being treated with

Tysabri, the brain infection that led to the drug being withdrawn in 2005.

In a filing to the US Securities and Exchange Commission, the two

companies said they had notified the relevant regulatory agencies of two

confirmed cases of PML in MS patients treated with Tysabri

(natalizumab). The first case involves a treatment-naive patient who had

been taking the drug as monotherapy for around 17 months, but " remains

clinically stable and ambulatory at home " .

The second case involves a patient, who is currently hospitalised, who

was taking Tysabri as monotherapy for 14 months but has a history of

prior disease-modifying therapies including azathioprine and

beta-interferons. These are the first cases to be recorded since the

reintroduction of natalizumab in the USA and approval in Europe two

years ago. Biogen and Elan had voluntarily withdrawn the drug a year

earlier after three patients developed PML.

Since re-introduction, Tysabri has boomed and earlier this month the two

companies noted that some 31,800 patients were being treated with the

drug, which had second-quarter sales of $200 million. It has also

recently been approved in the USA as a treatment for Crohn's disease.

Given the increase in patients on Tysabri, fresh cases of PML come as no

surprise and the fact that the plight of the two patients, who are both

in the European Union, has been identified so quickly is proof that

Biogen and Elan's stringent monitoring programme for the therapy is

working. Nevertheless, as Stanley analyst Harr has pointed

out in a research note, doctors may be less keen to start patients on

Tysabri as they are reminded of the long-term potential safety issues.

This is the second blow in as many days for Elan's stock which lost

one-third of its value on Wednesday over mixed data from a Phase II

trial of the experimental Alzheimer's drug bapineuzumab which is being

developing with Wyeth. The Irish firm and Biogen will host a conference

call to discuss the cases at 1:30 this afternoon, UK time.

By Grogan