Friday, October 21
Study lifts prospects for return of Tysabri
Biogen, Elan say no more cases found of rare brain disease....
The news bolstered prospects for Tysabri's return to the market in a limited fashion.MORE - The Boston GlobeBiogen Idec Inc. of Cambridge and its partner, Elan Corp., yesterday said they have completed a safety review of all the patients who took the multiple sclerosis drug Tysabri and did not find more cases of a rare brain disease that infected three patients.
The news bolstered prospects for Tysabri's return to the market in a limited fashion.
''The overall prognosis has improved for Tysabri," said Ian Sanderson, an analyst with S.G. Cowen Securities in Boston. ''It helps things a little bit."
Biogen Idec and Elan, its Irish partner in the drug, halted sales and dosing of Tysabri in February after one patient died of the disease, called progressive multifocal leukoencephalopathy, and another was suspected of contracting it. Of the three patients confirmed with contracting the disease, two died.
Tysabri was approved last November to treat MS and was on sale for only three months. It was also being tested in patients suffering from rheumatoid arthritis and Crohn's disease, an intestinal ailment. The final part of the review revealed yesterday confirmed there weren't any more cases of PML in the 1,500 patients participating in clinical trials for rheumatoid arthritis and Crohn's disease.
''We're encouraged by the findings of the safety evaluation," said Amy Brockelman, a Biogen Idec spokeswoman. ''There's a significant unmet need in multiple sclerosis, and we hope to bring the product back to patients in need."
The two companies last month submitted a revised marketing plan to the Food and Drug Administration, including changed labeling language. The companies asked for ''accelerated review" of the revised plan.
The FDA has 30 days in which to decide whether it will accelerate the review. If it does, the agency would rule on Tysabri within six months, compared to about a year for standard review.
Sanderson said he believed Tysabri would ultimately generate annual revenue of $400 million to $500 million for the two firms. That is considerably higher than some earlier estimates of how Tysabri might perform if it was again approved for sale, but considerably lower than the billion-dollar blockbuster most anticipated when the drug was introduced.
Posted by MSnewsChanel.com.com at 10/21/2005 03:54:00 PM