BASEL (dpa-AFX) - Biogen Idec Inc. (BIIB) said Friday that regulators in Europe have granted the company's multiple sclerosis drug Tecfidera a 'new active substance' designation, enabling the biotechnology company to clear a major hurdle for launch of the drug in Europe. Multiple sclerosis is a chronic disease of the central nervous system that may lead to paralysis and loss of vision.
Biogen Idec said that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency has determined that dimethyl fumarate in Tecfidera qualifies as a 'new active substance' or NAS.
The designation will provide 10 years of regulatory exclusivity for Tecfidera in the European Union. This means that the drug will get added protection against launch of generic copies of the drug in Europe by other companies.
Douglas Williams, executive vice president of Research and Development at Biogen Idec said, 'We are heartened by the CHMP's NAS determination, which brings us closer to our goal of providing this important new treatment to multiple sclerosis (MS) patients in Europe. We are ready to introduce TECFIDERA in EU countries shortly after anticipated approval.'
The NAS determination follows a positive opinion by the CHMP in March 2013 that recommended a marketing authorization in the EU for Tecfidera as a first-line oral treatment for adults with relapsing-remitting multiple sclerosis. The CHMP's determination will now be referred to the European Commission or EC, which grants marketing authorization for medicines in the EU.
Tecifdera will now compete with Novartis AG's (NVS) oral Gilenya, though the drug has led to concerns about heart safety. Gilenya generated worldwide sales of $1.2 billion last year. Tecfidera will also compete with Sanofi's (SNY) MS drug Aubagio.
In late March, Biogen Idec said that the U.S. Food and Drug Administration approved Tecfidera as a new first-line oral treatment for patients suffering from forms of multiple sclerosis. Tecfidera is currently approved in the United States, Canada and Australia.
BIIB closed Friday's regular trading session at $285.62, up $33.19 or 13.15 percent on a volume of 4.70 million shares.
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