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PHARMA/BIOTECH UPDATE: Biogen Idec’s Hemo A Drug Delayed

November 12, 2013; Posted by: webleed staff

The FDA has requested more information about the way manufacturing data of Biogen Idec Inc’s new Hemophilia A drug “Eloctate” are collected and reported.  Originally projected to be released in the first half of 2014, Tony Kingsley, the head of operations for Biogen, told an audience today at a Credit Suisse conference that the delay is equal to about 90 days.  This moves market entry to mid-2014.

“The FDA requested additional information related to certain steps in the validation process in our manufacturing,” Kingsley said today. “We are working with them to provide that information.”

Eloctate is projected to draw nearly $700 million in revenue for Biogen in 2020.

Photo Credit: AP

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