Posted on 03/03/2005 8:44:21 PM PST by neverdem
The makers of the multiple sclerosis drug Tysabri said yesterday that a second patient who used the drug had been confirmed to be suffering from a rare but deadly brain infection. The confirmed diagnosis is likely to somewhat diminish the chances that the drug will be able to return to the market.
The makers of the drug, Biogen Idec and Elan, halted sales and clinical trials on Monday, saying that one patient in a clinical trial had died from the brain infection and a second patient from the same trial, who was still alive, was also suspected of having it.
The companies also said yesterday that they had "undertaken to provide information" to the Securities and Exchange Commission about the suspension of sales, which led to major declines in the stocks of both companies. Anita Kawatra, a spokeswoman for Elan, said, "Our understanding is it's a routine inquiry related to the stock price move."
A few executives or directors of Biogen sold shares in the days just before the company said it learned of the possible problem with Tysabri. One executive sold on the same day that the company told regulators about the problem. A company spokesman said the executives did not know of the situation with Tysabri when they sold.
The brain infection, called progressive multifocal leukoencephalopathy, or P.M.L., is extremely rare, so even one confirmed case raised alarms, officials of the companies have said. The confirmation of a second case is stronger evidence that the disease is linked to the drug.
The two patients were among 500 people in a trial who had received both Tysabri and Avonex, another Biogen multiple sclerosis drug, for more than two years.
Biogen and Elan reiterated yesterday that they had received no reports of P.M.L. in patients who received Tysabri alone. Avonex has been on the market for years and has never been associated with the condition when used alone.
Tysabri was approved only three months ago and was viewed by many doctors as a major advance. Analysts expected sales to eventually surpass $2 billion a year.
Biogen and Elan, based in Ireland, plan to meet today with experts on P.M.L.
The disease is caused by the reactivation of a virus that is present in most adults but is usually controlled by the immune system. In some people with severely weakened immune systems, particularly those with AIDS, the virus infects the brain cells responsible for making the insulation around nerve cells. Death often comes in a few months.
Some law firms have announced shareholder lawsuits against Biogen, and at least one has said it would file a suit against Elan.
FReepmail me if you want on or off my health and science ping list.
But maybe not, as Chris Rock says;
"They're still mad over the money they lost curing Polio."
And this crowd wants herbs and vitamin/mineral supplements to be obtainable only by prescription because they pose a danger!
Their example is, "It's the German thing to do".
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