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

Curis Announces The Conditional Approval Of Erivedge(R) In The European Union

Stocks in this article: CRIS

LEXINGTON, Mass., July 15, 2013 (GLOBE NEWSWIRE) -- Curis, Inc. (Nasdaq:CRIS), an oncology-focused drug development company seeking to develop novel drug candidates for the treatment of human cancers, today announced that the European Commission has granted conditional approval to Erivedge ® (vismodegib) for the treatment of adult patients with symptomatic metastatic basal cell carcinoma (BCC) or locally advanced BCC inappropriate for surgery or radiotherapy. This conditional approval makes Erivedge the first licensed treatment in Europe for patients with advanced BCC, a rare form of skin cancer which can be disfiguring, debilitating and even fatal.

"We are extremely pleased that Erivedge will now be available as the first approved medicine in the European Union (EU) for patients with advanced basal cell carcinoma, a serious medical condition," stated Dan Passeri, Curis' Chief Executive Officer. "Roche's development and commercialization efforts have significantly expanded global patient access and the market opportunity for Erivedge, with regulatory approvals for Erivedge in the United States, Switzerland, Australia, Israel, South Korea, Mexico, and Ecuador, in addition to the EU. We expect that Roche will seek approval of Erivedge in several other territories and anticipate that these efforts will continue to expand the number of patients that will have access to this important medicine in the near future."

The European Commission granted the conditional approval based upon the positive recommendation received in April this year from the Committee of Medicinal Products for Human Use of the European Medicines Agency (EMA). The European Commission's decision will be applicable to all 28 European Union member states. As a result of this conditional approval, Curis earned a $6 million milestone payment from Genentech, a member of the Roche Group, and will continue to be entitled to receive royalties on future sales of Erivedge. Roche is responsible for commercializing Erivedge in the EU. A conditional marketing authorization is granted to medicinal products with a positive benefit/risk assessment that satisfy an unmet medical need and whose availability would result in a significant public health benefit. Under the provisions of the conditional approval, Roche is expected to provide additional data on Erivedge in advanced BCC from an ongoing global safety study.

1 of 4

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

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
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

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
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, 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
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

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

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
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!
DOW 16,974.31 -31.44 -0.18%
S&P 500 0.00 -2.75 -0.14%
NASDAQ 4,549.2260 -15.0680 -0.33%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

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