Elan falls 12pc despite Tysabri nod Tuesday June 6th 2006
Elan falls 12pc despite Tysabri nod Tuesday June 6th 2006
SHARES in the Irish pharmaceutical group Elan fell sharply in New York last night on the back of fears that sales of its MS drug Tysabri would fall below expectations.
Despite news that the FDA had given approval for its return to market, dealers focussed on the possible restrictions to be placed on the drug when it returns.
In late trading last night, Elan shares on the Nasdaq market continued a weakening trend and closed down over 12pc in heavy trading at $16.60.
In an earlier announcement, Elan said it and partner Biogen had won US approval to resume sales of their Tysabri multiple sclerosis drug, pulled from the market last year because of a fatal side effect.
The treatment is for patients who haven't responded to older drugs or can't tolerate them, the Food and Drug Administration said yesterday in a statement.
A government advisory committee in March recommended that Tysabri be approved as a first-choice treatment.
Monitor
The agency mandated strict measures to monitor side effects. Tysabri, welcomed as the best hope in a decade for multiple sclerosis sufferers when approved in November 2004, was removed from the market three months later after being linked to a rare, fatal brain infection.
At the March meeting, patients and the companies cited research showing the drug is twice as effective as other treatments against a debilitating neurological disorder that affects 400,000 Americans.
The safety programme "will help patients and physicians assess the benefits and risks of Tysabri and make informed decisions about therapy," Biogen chief executive officer James C Mullen said in a statement.
Shares of Cambridge, Massachusetts based Biogen fell $1.64, or 3.4pc, to $46.07 on the Nasdaq. The stock had gained 31pc in the 12 months through June 2. Tysabri will be administered only at registered infusion centers and Biogen will implement distribution controls.
Patients will be required to participate in a registry and will have to read and sign a form confirming they understand Tysabri's risks. Each patient will be assigned an authorisation number.
People taking Tysabri face a 1 in 1,000 risk of contracting the neurological disorder progressive multifocal leukoencephalopathy, or PML, according to the National Institutes of Health. Three patients contracted the disease, which caused two deaths.
The product is only the second drug to be put back on the US market following a safety-related suspension. The only other was GlaxoSmithKline Plc's irritable bowel drug Lotronex, returned to the market with restrictions in 2002 after a link to patient deaths.
Tysabri sales were halted in February, 2005, on the first reported death from PML, wiping out $17.8bn in combined market value for Biogen and Ireland-based Elan.
Pat Boyle
http://www.unison.ie/business/stories.php3?ca=80&si=1628234
SHARES in the Irish pharmaceutical group Elan fell sharply in New York last night on the back of fears that sales of its MS drug Tysabri would fall below expectations.
Despite news that the FDA had given approval for its return to market, dealers focussed on the possible restrictions to be placed on the drug when it returns.
In late trading last night, Elan shares on the Nasdaq market continued a weakening trend and closed down over 12pc in heavy trading at $16.60.
In an earlier announcement, Elan said it and partner Biogen had won US approval to resume sales of their Tysabri multiple sclerosis drug, pulled from the market last year because of a fatal side effect.
The treatment is for patients who haven't responded to older drugs or can't tolerate them, the Food and Drug Administration said yesterday in a statement.
A government advisory committee in March recommended that Tysabri be approved as a first-choice treatment.
Monitor
The agency mandated strict measures to monitor side effects. Tysabri, welcomed as the best hope in a decade for multiple sclerosis sufferers when approved in November 2004, was removed from the market three months later after being linked to a rare, fatal brain infection.
At the March meeting, patients and the companies cited research showing the drug is twice as effective as other treatments against a debilitating neurological disorder that affects 400,000 Americans.
The safety programme "will help patients and physicians assess the benefits and risks of Tysabri and make informed decisions about therapy," Biogen chief executive officer James C Mullen said in a statement.
Shares of Cambridge, Massachusetts based Biogen fell $1.64, or 3.4pc, to $46.07 on the Nasdaq. The stock had gained 31pc in the 12 months through June 2. Tysabri will be administered only at registered infusion centers and Biogen will implement distribution controls.
Patients will be required to participate in a registry and will have to read and sign a form confirming they understand Tysabri's risks. Each patient will be assigned an authorisation number.
People taking Tysabri face a 1 in 1,000 risk of contracting the neurological disorder progressive multifocal leukoencephalopathy, or PML, according to the National Institutes of Health. Three patients contracted the disease, which caused two deaths.
The product is only the second drug to be put back on the US market following a safety-related suspension. The only other was GlaxoSmithKline Plc's irritable bowel drug Lotronex, returned to the market with restrictions in 2002 after a link to patient deaths.
Tysabri sales were halted in February, 2005, on the first reported death from PML, wiping out $17.8bn in combined market value for Biogen and Ireland-based Elan.
Pat Boyle
http://www.unison.ie/business/stories.php3?ca=80&si=1628234
posted by Bill at 12:33 AM
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