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Will Tysabri make it back to market?
Biogen continues to make drug, in hopes of return
By Val Brickates Kennedy, MarketWatch
Last Update: 7:24 PM ET May 12, 2005
BOSTON -- It's been nearly three months since Biogen Idec Inc. voluntarily pulled its multiple sclerosis drug Tysabri from the market over safety concerns, but the company holds out hope the treatment will make a comeback.
Not only does Cambridge, Mass.-based Biogen continue to maintain inventories of the drug, it also has retained its nearly 100 Tysabri salespeople along with its marketing team.
And at least for now, Biogen (BIIB: news, chart, profile) still produces Tysabri, albeit at a lower rate. Biogen co-markets Tysabri with Irish drugmaker Elan Corp. Plc. (ELN: news, chart, profile)
"We have a pretty good feeling that it will go back on the market," said Peter Kellogg, Biogen's chief financial officer. "We had a lot of people lining up for the drug [before the recall] and they're still inquiring."
While Biogen management continues to be hopeful, one question continues to vex biotechnology investors and medical professionals alike: Can Tysabri, once hailed as a wonder treatment for multiple sclerosis, really make it back to the market?
Tysabri was recalled by Biogen and Elan on Feb. 28 after two members of an MS clinical trial were discovered to have developed progressive multifocal leukoencephalopathy, or PML, an extremely rare but deadly brain infection seen mostly in AIDS patients. One patient died.
A subsequent review of Tysabri patient records revealed a third user also had died of PML, during a clinical trial for the treatment of Crohn's disease.
As a result, Biogen and Elan have suspended all clinical trials of the drug until it figures out what triggered the PML cases. The companies are engaged in a review of all Tysabri patient files in an effort to solve the puzzle and plan to discuss the results with the Food and Drug Administration later this summer.
Skepticism
Biogen and Elan are trying to get Tysabri back on the market to treat MS as soon as possible, but it's likely to be greeted with a good measure of skepticism, analysts say.
"Confidence in the drug has been damaged," says Deutsche Bank analyst Jennifer Chao. "It will take time for physicians to regain confidence in the drug."
"I think there's a high possibility that Tysabri will be relaunched onto the market, but with significant labeling," said Chao, who doesn't see Tysabri back on the market before 2006. "I think the FDA will likely insist upon long-term, post-marketing clinical trials. They may allow a relaunch contingent upon finishing those trials."
Biogen has continued to make Tysabri largely to keep up its inventories of the drug, which takes months to produce, in case of a relaunch down the road.
The company plans to destroy all returned quantities of the drug, out of safety concerns. Biogen will make a decision as to whether to keep producing the drug sometime next quarter, when it expects the results of its safety review to be completed.
Based on the antibody natalizumab, Tysabri originally was developed by Elan, which saw its potential in treating such autoimmune disorders as MS and Crohn's disease.
MS, a progressive disease where the immune system attacks the body's central nervous system, is characterized by lesions on the brain and bouts of physical debilitation. About 400,000 Americans have from the illness.
To print: Select File and Then Print in your browser pull-down menus. Back to story
Will Tysabri make it back to market?
Biogen continues to make drug, in hopes of return
By Val Brickates Kennedy, MarketWatch
Last Update: 7:24 PM ET May 12, 2005
BOSTON -- It's been nearly three months since Biogen Idec Inc. voluntarily pulled its multiple sclerosis drug Tysabri from the market over safety concerns, but the company holds out hope the treatment will make a comeback.
Not only does Cambridge, Mass.-based Biogen continue to maintain inventories of the drug, it also has retained its nearly 100 Tysabri salespeople along with its marketing team.
And at least for now, Biogen (BIIB: news, chart, profile) still produces Tysabri, albeit at a lower rate. Biogen co-markets Tysabri with Irish drugmaker Elan Corp. Plc. (ELN: news, chart, profile)
"We have a pretty good feeling that it will go back on the market," said Peter Kellogg, Biogen's chief financial officer. "We had a lot of people lining up for the drug [before the recall] and they're still inquiring."
While Biogen management continues to be hopeful, one question continues to vex biotechnology investors and medical professionals alike: Can Tysabri, once hailed as a wonder treatment for multiple sclerosis, really make it back to the market?
Tysabri was recalled by Biogen and Elan on Feb. 28 after two members of an MS clinical trial were discovered to have developed progressive multifocal leukoencephalopathy, or PML, an extremely rare but deadly brain infection seen mostly in AIDS patients. One patient died.
A subsequent review of Tysabri patient records revealed a third user also had died of PML, during a clinical trial for the treatment of Crohn's disease.
As a result, Biogen and Elan have suspended all clinical trials of the drug until it figures out what triggered the PML cases. The companies are engaged in a review of all Tysabri patient files in an effort to solve the puzzle and plan to discuss the results with the Food and Drug Administration later this summer.
Skepticism
Biogen and Elan are trying to get Tysabri back on the market to treat MS as soon as possible, but it's likely to be greeted with a good measure of skepticism, analysts say.
"Confidence in the drug has been damaged," says Deutsche Bank analyst Jennifer Chao. "It will take time for physicians to regain confidence in the drug."
"I think there's a high possibility that Tysabri will be relaunched onto the market, but with significant labeling," said Chao, who doesn't see Tysabri back on the market before 2006. "I think the FDA will likely insist upon long-term, post-marketing clinical trials. They may allow a relaunch contingent upon finishing those trials."
Biogen has continued to make Tysabri largely to keep up its inventories of the drug, which takes months to produce, in case of a relaunch down the road.
The company plans to destroy all returned quantities of the drug, out of safety concerns. Biogen will make a decision as to whether to keep producing the drug sometime next quarter, when it expects the results of its safety review to be completed.
Based on the antibody natalizumab, Tysabri originally was developed by Elan, which saw its potential in treating such autoimmune disorders as MS and Crohn's disease.
MS, a progressive disease where the immune system attacks the body's central nervous system, is characterized by lesions on the brain and bouts of physical debilitation. About 400,000 Americans have from the illness.
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