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Tysabri Sales Show Little Impact From Labeling Change, Biogen Idec Says

This article was originally published in The Pink Sheet Daily

Executive Summary

The MS drug reached blockbuster status in 2009, with net sales of $1.1 billion.

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FDA's briefing documents for March 1 advisory committee review note that the kidney transplant rejection agent is linked to a potentially fatal adverse event.

Business News In Brief

Roche primary care "scale up": Ahead of a potential launch of the GLP-1 analog taspoglutide for the treatment of type 2 diabetes, Roche will need to "scale up" its primary care infrastructure, Pharmaceuticals Chief Operating Officer Pascal Soriot said during an investor meeting in New York Feb. 4. If approved, the drug would compete against entrenched rivals, including Lilly/Amylin's established Byetta (exenatide) and Novo Nordisk's recently approved Victoza (liraglutide). Still, Soriot maintained, "the scale-up is not as big as people ultimately think." In the U.S., the company already has a primary care infrastructure in place, he said, including 570 reps visiting physician offices and 250 visiting clinics. The filing for taspoglutide has been pushed back to 2011 from an earlier target of 2010 due to a delay in the start of a large cardiovascular safety study, T-EMERGE 8. Roche is expecting to file once interim results are in hand

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