OT: Tysabri latest news

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Biogen says Tysabri PML patient dies in U.S.

By Toni e Friday, Dec. 19, 2008; 4:27 PM

BOSTON (Reuters) - Biogen Idec Inc said on Friday that a multiple

sclerosis patient who had been diagnosed with a rare brain infection

while taking its drug Tysabri has died, sending the company's shares

down nearly 3 percent.

Biogen and its partner Elan Corp Plc disclosed the case in October.

Naomi Aoki, a spokeswoman for Biogen, said the company learned of the

patient's death earlier this week.

Tysabri is seen as crucial to the growth of both companies. The drug

was temporarily withdrawn from the market in 2005 after it was linked

with a rare brain infection known as progressive multifocal

leukoencephalopathy, or PML.

The drug was reintroduced in July 2006 with stricter safety warnings.

So far, there have been four new cases of PML, an infection rate that

is still less than the one in 1,000 warned of in the drug's label.

Nearly 18,000 patients have received at least a year of Tysabri. But

investors are watching to see if the rate increases, and they are also

looking at how successfully patients can recover.

" While we continue to believe the benefit/risk profile of Tysabri as

favorable, we believe this death could lead the FDA and physicians to

alter how future PML cases are managed, " said , an

analyst at Rodman & Renshaw.

The patient who died was a United States patient who had received 14

monthly infusions of Tysabri as a stand-alone treatment. Previously

she had received other therapies.

After developing the brain infection, the patient was treated with a

procedure known as plasmapheresis, in which blood is removed, cleared

of the drug, and replaced.

While the U.S. patient died, two patients who developed PML in Europe,

and whose cases were announced in July, appear to be recovering

following treatment, even though one had not been expected to survive.

Earlier this month, Biogen announced that a fourth patient had

developed PML. This patient, in Europe, is still alive.

The European patient that had not been expected to survive had

developed a condition known as immune reconstitution inflammatory

syndrome, or IRIS. This occurs when the immune system, in eliminating

an infection, produces an excessive inflammatory response that can

worsen symptoms.