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MS Drug Tysabri's Return Endorsed

Posted on: Thursday, 9 March 2006, 18:00 CST

By Penni Crabtree, The San Diego Union-Tribune

Mar. 9--A key advisory committee to the Food and Drug Administration unanimously endorsed the return of multiple sclerosis drug Tysabri to the market yesterday, making it likely that the FDA will give its final consent later this month.

The panel of 12 doctors and scientists backed the drug as a treatment for relapsing forms of MS and also voted 7-5 in favor of its use as a first-choice medicine, which means patients don't have to wait until other MS drugs fail before using it.

The FDA usually follows the advice of its expert panels.

The thumbs up from the panel came after a two-day hearing that included emotional testimony from multiple sclerosis patients who argued that the benefits of the drug outweigh the rare risk of activating a virus that can trigger an often fatal brain disorder.

Clinical studies indicate that Tysabri is twice as effective as other MS treatments. But the drug's makers, Biogen Idec and Elan, pulled it from the market last year after three patients developed the disorder known as progressive multifocal leukoencephalopathy, or PML.

Multiple sclerosis patients who testified before the FDA panel were jubilant yesterday about the outcome. Lauren Roberts, 51, a Palmdale woman who testified via video, said she was devastated when Tysabri was taken off the market.

Roberts, who must use a wheelchair, was still mobile when she received her first infusion of the drug early last year. She said she experienced improved balance and less foot-dragging, a symptom of the disease.

Multiple sclerosis affects the central nervous system, attacking a tissue that protects delicate nerve fibers. When the nerve fibers are damaged, their ability to transmit signals to the brain is impaired, producing symptoms such as memory loss, weakness and poor muscle coordination.

"I'm overjoyed and ecstatic," Roberts said. "I've been crying tears of joy since I found out the panel's decision. I think they put politics aside and listened to the patients."

Trading in both companies' stocks was halted during the two-day FDA meeting, but investors were also clearly pleased with the outcome. Shares of Irish drug maker Elan rose 25 percent, or $3.11, to close at $15.81. Shares of Cambridge, Mass.-based Biogen Idec did not resume trading until after the market closed, but in after-hours trading they rose as much as 9 percent.

Both companies maintain research or administrative units in San Diego.

Tysabri is an important drug for both companies, though more so for Elan.

Elan is counting on Tysabri to return it to profitability; Biogen Idec is already profitable and has other approved drugs, including the top-selling branded cancer drug, Rituxan, which it markets with Genentech.

Before Tysabri was withdrawn from the market, Wall Street analysts had speculated it would become the treatment of choice for multiple sclerosis and reap as much as $3 billion in annual sales.

Now a more restricted use is expected, although the drug could still reach peak sales of $1 billion, according to some analysts.

Although most on Wall Street believe the FDA will abide by the advisory panel's recommendation and allow sales of Tysabri to resume, details about how the companies plan to control the risk of PML and monitor patients for the ailment have yet to be worked out.

The FDA advisory panel said Tysabri must have mandatory controls to ensure that patients know the risks and that any new cases of a possibly fatal brain infection are spotted quickly.

The companies' risk-management plan calls for a mandatory registry of doctors who prescribe the drug. It also calls for patients who take it to better monitor for PML and to ensure that the drug is used as intended.

In a written statement yesterday, Biogen Idec and Elan said they will work closely with the FDA to, among other things, finalize the details of a Tysabri risk-management plan.

For Wall Street, the devil may be in details. If the plan proves too restrictive or burdensome, physicians are likely to reserve Tysabri for a smaller set of patients.

"These requirements will be critical for penetration," according to a research note yesterday by Goldman Sachs Global Investment. "We continue to believe that Tysabri will re-enter the market with a restricted label and slow ramp-up."

Sanford Bernstein analyst Geoff Porges predicted Tysabri sales of $700 million annually by 2010.

"Initially, there are going to be a lot of desperate patients who jump on it, but it's probably going to be a slow build," he said.

Bloomberg News contributed to this report.

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Source: The San Diego Union-Tribune

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