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Grappling With Risks, Rewards Of Ms Drug

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Grappling with risks, rewards of MS drug

Managing risk is part of everyday business. But how do you deal with fear? Fear management has been a key challenge at Biogen Idec for the...

By STEVEN SYRE

The Boston Globe

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Managing risk is part of everyday business. But how do you deal with fear?

Fear management has been a key challenge at Biogen Idec for the past four years, since a few patients taking the company's promising new multiple-sclerosis drug, Tysabri, unexpectedly developed a rare but potentially lethal brain disease.

Biogen Idec shares were crushed at the time, losing 43 percent of their value in a single day. Regulators pulled Tysabri off the market until they could figure out what to do. Biogen Idec was allowed to reintroduce the drug 16 months later, but everyone continued to struggle to understand an unusual puzzle of risk and reward.

Biogen Idec's quarterly financial report last week included some of its most upbeat news to date on Tysabri.

Chief Executive Jim Mullen told investors the drug was developing into a certified "blockbuster." The company said total sales exceeded $250 million, putting it on track to generate more than $1 billion a year in revenues (Biogen Idec shares rights to Tysabri with Elan and claimed only $188 million of total sales in the results).

Tysabri sales had increased by an impressive 27 percent during the quarter. More important, the pace of new patients starting to take the drug accelerated. About 262 patients started taking Tysabri weekly during the second quarter, compared with about 170 per week in previous periods.

Those gains weren't achieved in a bad-news vacuum. Three new cases of progressive multifocal leukoencephalopathy, a viral brain disease known as PML, were reported among Tysabri patients in the month of June alone. A total of 10 cases have been reported since Tysabri returned to the market in 2006.

Stock analyst Eric Schmidt of Cowen & Co. said the new PML cases would dampen the impact of higher Tysabri sales on Biogen Idec shares. But "it is clear that Tysabri's growth continues despite all the negative attention the drug receives on Wall Street," he wrote in a note to investors Thursday.

By the end of June, 43,000 patients were taking Tysabri to treat multiple sclerosis, about half of them in the United States. They accepted a PML risk that is unlikely but very serious. How rare the complication will be over longer treatment remains unknown.

Many patients take Tysabri because it makes a dramatic difference in their lives. The drug can help some patients slow the progression of disability and manage effects of multiple sclerosis, improving their lives to a degree that makes the longshot risk of PML worth taking.

Biogen Idec executives work hard to help patients reach that decision. They argue the potential side effect, which has affected 13 patients, isn't as deadly as previously feared and point to treatment. They plaster the marketplace with information.

"We have a significant advantage," says Michael Panzara, Biogen Idec's chief medical officer for neurology. "You're starting from a place that, despite a rare risk, you have a drug that clearly does for MS patients what no other drug can do."

function ebStdBanner0_DoFSCommand(command,args){try{command = command.replace(/FSCommand:/ig,"");if((command.toLowerCase()=="ebinteraction") || (command.toLowerCase()=="ebclickthrough"))gEbStdBanners[0].handleInteraction();}catch(e){}}try{ebStdBanner0_DoFSCom

mand(command,args);}catch(e){}What Tysabri needs is more time. A year from now, Biogen Idec will have more information about patients who have been on its drug for a year, or two years or three years. Larger pools of patients who have been using the drug for longer periods will help define how much of a risk Tysabri might pose.

Considering all the Wall Street focus on Tysabri, you might think the drug was Biogen Idec's big-money product. Not so. The company's other MS drug, Avonex, generates much more revenue. Rituxan, which treats rheumatoid arthritis and non-Hodgkin lymphoma, outsells Tysabri, too.

But Tysabri is an important part of the growth story. Success would be sweet, and failure would be a serious setback.

Overcoming fear of any kind is no easy proposition. The Biogen Idec experience with patients suggests it takes time and many small steps.

Copyright © 2009 The Seattle Times Company

SOURCE: http://seattletimes.nwsource.com/html/heal...btbiogen20.html

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