This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
TheStreet Open House

Biogen Wins Key European Protection for MS Pill Launch

Stocks in this article: BIIB

Biogen Idec  (BIIB - Get Report) cleared an important hurdle for the European launch of Tecfidera after regulators there decided Friday to grant market exclusivity to the multiple sclerosis pill. 

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:


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.

-- Reported by Adam Feuerstein in Boston.

Follow Adam Feuerstein on Twitter.

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

Check Out Our Best Services for Investors

Action Alerts PLUS

Jim Cramer and Stephanie Link reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

Jim Cramer's protégé, David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
Try it NOW
Try it NOW
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

Jim Cramer's protégé, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
Try it NOW
Try it NOW
Try it NOW
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!

Markets

DOW 17,164.95 -251.90 -1.45%
S&P 500 1,994.99 -26.26 -1.30%
NASDAQ 4,635.24 -48.1670 -1.03%

Partners Compare Online Brokers

Free Reports

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs