Biogen Idec, maker of the multiple sclerosis drugs Avonex and Tysabri, won European Union backing for Tecfidera, its first pill for the central nervous system disease.
Biogen should be granted marketing authorization for the drug, the European Medicines Agency’s Committee for Medicinal Products for Human Use said in a statement Friday. The European Commission usually follows the committee’s advice.
The drug, formerly known as BG-12, will follow Novartis’s Gilenya to the market in the EU as an oral option for the treatment of MS. Because of its safety profile and efficacy, Weston, Mass.-based Biogen’s Tecfidera may generate $3.25 billion in annual revenue by 2017, based on the average analyst estimate compiled by Bloomberg.
Biogen employs more than 1,000 people at its Research Triangle Park campus.
Multiple sclerosis affects an estimated 2.1 million people worldwide, causing symptoms ranging from limb numbness to blindness and paralysis, according to the National Multiple Sclerosis Society. Other MS drugs, including Biogen’s, are given by injection or intravenous infusion, and patient anticipation for Tecfidera may drive it to capture as much as 20 percent of the MS market within a year, according to Eric Schmidt, a Cowen & Co. analyst.
“This will probably be the No. 1 drug in MS,” said Michael Yee, an analyst with RBC Capital Markets in San Francisco, in a telephone interview this week. He recommends buying Biogen shares.
Biogen’s stock has doubled since April 2011 when the company first reported positive data from a late-stage trial of Tecfidera. The results were better than analysts and investors had expected, and they were bolstered later that year with results from a second trial, dubbed Confirm.
The most common form of MS is relapsing-remitting, characterized by neurological attacks followed by periods of recovery. The studies together showed that Tecfidera reduced patients’ annual relapse rate by 49 percent when given either twice a day or three times a day, and cut the proportion of patients who relapsed by 43 percent at twice-daily dosing and 47 percent at three times daily compared with placebo.
Overall, side effects were similar across the placebo and treatment groups, with the most common adverse events associated with Tecfidera being flushing and gastrointestinal effects, the company said.
A decision on Tecfidera is due from the U.S. Food and Drug Administration by Thursday. The drug was delayed by the FDA in October for three months without asking for additional studies. The agency said it needed more time to review the application, Biogen said.
Staff writer David Bracken contributed.