Biogen Idec Inc. (BIIB), the world’s biggest maker of multiple sclerosis drugs, surged the most in 20 months on investor optimism that the company’s Tecfidera pill may gain protection from generic-drug competition in Europe.
Biogen climbed 4.8 percent to $218.85 at 12:59 p.m. New York time, after increasing 16 percent in its biggest intraday gain since October 2011. European regulators may rule later this year on whether to approve Tecfidera, already cleared in the U.S., the Weston, Massachusetts-based company said in May.
The European Medicines Agency’s Committee for Medicinal Products for Human Use today granted “new active substance” status to Sanofi’s MS treatment Aubagio, which protects the medicine from generic competition for 10 years. The ruling may help Biogen gain protection for Tecfidera as well, said Brian Abrahams, an analyst at Wells Fargo & Co. in New York.
The Sanofi ruling shows the European regulator “is open to a sponsor’s arguments that a new drug should merit some regulatory exclusivity,” Abrahams said in a note. “We see this as an indirect, incremental positive.”
Tecfidera was approved in the U.S. in March. Biogen has asked the European regulator for exclusivity under a process referred to as the “independent development principle,” Abrahams said. On May 30, Biogen said a European regulatory decision on its pill would be delayed until the second half of this year while the company seeks clarity of the drug’s exclusivity.
The new status for Aubagio also reduces the chance that a generic medicine will contribute to price erosion in the European market for MS therapies, Abrahams said.
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