Tecfidera qualifies as a "new active substance," European regulators said, which along with patents, should give Biogen the market protection it needs to begin selling the drug in Europe later this year.
Biogen had put the European launch of Tecfidera on hold while it worked to gain protection against the early entrance of cheaper generic copies.
Biogen shares rose 9% to $275 in early Friday trading.
J.P. Morgan biotech analyst Geoff Meacham reacted to the decision:
-- Reported by Adam Feuerstein in Boston. Follow Adam Feuerstein on Twitter.
This morning, the CHMP granted Tecfidera regulatory data protection in EU, preventing generic competition for 10 years post launch. Tecfidera is now deemed a 'new active substance,' according to EU regulators. Recall, the CHMP recommended Tedfidera for approval in March, but Biogen delayed the launch to secure appropriate data exclusivity. While this process has been somewhat of a black box, Biogen has maintained it is entitled to regulatory data protection. We are not surprised by the favorable outcome and note that investor sentiment was leaning towards this outcome. This is implied by the fact that EU Tecfidera forecasts have not changed much despite the RDP uncertainty. That said, removal of the RDP overhang is a positive and paves the way for a 1H14 launch. While data protection is a clear positive, looking ahead we remain concerned about the potential for cannibalization in the MS business as well as further upside to WW Tecifera forecasts. As such, we are maintaining our Neutral rating.
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