) shares shot up 13.15% immediately after the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) granted new active substance (NAS) designation to
dimethyl fumarate in the company's new oral multiple sclerosis
Tecfidera, which is currently available in the U.S. for the
treatment of people with relapsing forms of multiple sclerosis,
is yet to gain approval in the EU. Shortly after receiving a
positive opinion from the CHMP in Mar 2013 regarding the EU
approval of Tecfidera, Biogen had announced that it expects a
delay in the EU launch of Tecfidera as it continues to work on
strengthening its patent coverage.
With the NAS designation in place, Tecfidera will enjoy 10
years of regulatory exclusivity in the EU. Final approval in the
EU should come shortly.
Meanwhile, the drug is already off to a strong start in the
U.S. bringing in sales of $478 million since it was launched in
early April. Biogen reported that according to IMS, Tecfidera is
the leading oral multiple sclerosis therapy in the U.S.
The NAS designation for Tecfidera in the EU has removed a
significant concern surrounding the stock. Tecfidera is one of
the most important new products in Biogen's portfolio. Although
Tecfidera is protected by a European patent until 2028, the 10
years of regulatory exclusivity strengthens patent protection for
the candidate further.
Once approved in the EU, Tecfidera will enter the multiple
sclerosis market which has players like
) Gilenya and
Biogen currently carries a Zacks Rank # 3 (Hold). Some
better-ranked stocks include
). Actelion is a Zacks Rank #1 (Strong Buy) stock.
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