CHICAGO, April 10 (UPI) -- The risk-management plan that would accompany multiple-sclerosis drug Tysabri's return to market will not include patient waivers.

In a CNBC report Monday, Biogen Idec President and Chief Executive Officer James Mullen said the company is not looking to include in Tysabri's risk-management plan personal-injury waivers for patients to sign before taking Tysabri.

Noting that the risk-management plan is meant primarily as an educational tool for patients and doctors, Mullen said, "We are working intensely with FDA day-by-day to refine the risk management plan."

Mullen's remarks came on the heels of the release of two late-stage clinical trials of Tysabri showing that the drug improves the quality of life for MS patients. The studies were presented Monday at the BIO 2006 conference in Chicago.

Mullen said the Food and Drug Administration was already "fully aware" of the results of the new Tysabri studies, so the news would be unlikely to impact the agency's decision whether to follow its advisory panel's recommendation made earlier this month to return Tysabri to market.

An FDA decision is expected June 28.

Mullen declined to comment on whether a re-introduced Tysabri would be priced differently from when the drug was first introduced, noting the question of pricing was one for Biogen Idec's partner, Elan, based in Dublin, Ireland. He also noted the cost of the Tysabri risk-management plan was unlikely to have an impact on Biogen Idec's bottom line.

Tysabri was withdrawn from the market last year after three patients taking the drug developed a serious brain infection. Since that time an analysis conducted by the drug's sponsors revealed no further incidents of the disorder.
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