Biogen Idec announced that the US Food and Drug Administration (FDA) has approved the company's high titer process for the production of its multiple sclerosis (MS) drug Tysabri (natalizumab). Biogen Idec received similar approval from the European Medicines Agency (EMEA) for the high titer process in December 2008. The new, higher-yield process will be used to manufacture Tysabri at the company's plant in Research Triangle Park (RTP).
"Developing this high titer process is another example of our world-class expertise and leadership in biologics manufacturing," said Biogen Idec chief operating officer Bob Hamm. "We expect this new process to result in about a four-fold increase in yield."
Biogen Idec is a global leader in biologics manufacturing with capabilities and capacity for protein production that are world-class in quality and scale. Biogen Idec is one of a handful of biotechnology companies that has two licensed and dedicated biological bulk-manufacturing facilities, including its large-scale manufacturing plant in RTP, which is one of the world's largest cell culture facilities.
Tysabri, which is co-marketed with Elan Corporation, plc, is approved in more than 40 countries. Tysabri is approved in the United States for relapsing forms of MS and moderately-to-severely active Crohn's disease. It is approved in the European Union for relapsing-remitting MS.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies.
Tysabri is a treatment approved for relapsing forms of MS in the US and relapsing-remitting MS in the European Union. Tysabri is also approved in the US to induce and maintain clinical response and remission in adult patients with moderately-to-severely active Crohn's disease (CD) with evidence of inflammation in those patients who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-alpha. Tysabri increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Biogen Idec and Elan Corporation are in a 50-50 partnership for the development and promotion of the drug.