This Day On The Street
Continue to site
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

Curis Announces Collaborator Roche’s Submission Of Marketing Authorization Application For Vismodegib In Advanced Basal Cell Carcinoma

Curis, Inc. (NASDAQ: CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that its collaborator Roche has submitted a Marketing Authorization Application (MAA) for vismodegib (GDC-0449, RG3616) to the European Medicines Agency (EMA). The MAA is currently under review for the treatment of adults with advanced basal cell carcinoma (BCC) for whom surgery is considered inappropriate. Vismodegib is a first-in-class, investigational, oral medicine designed to selectively inhibit signaling in the Hedgehog pathway and is being developed by Roche and Genentech, under a collaboration agreement between Curis and Genentech, a member of the Roche Group.

Curis earned a $6 million milestone payment from Genentech as a result of the MAA submission to the EMA. If vismodegib receives Marketing Authorization by the EMA , Curis will also be entitled to receive an additional milestone payment as well as royalties on any future sales.

"We continue to be extremely pleased with Roche and Genentech’s efforts in progressing vismodegib towards commercialization. Vismodegib is now under review for approval in both the United States and Europe, with an FDA PDUFA action date of March 8, 2012, in the U.S.," said Dan Passeri, Curis President and Chief Executive Officer. "Vismodegib represents a potential advance for patients suffering from this serious and debilitating form of BCC, for whom no current therapeutic alternatives are available. We continue to remain hopeful that this important treatment for advanced BCC will be approved in these territories."

The application is based on clinical data from ERIVANCE BCC/SHH4476g, a pivotal Phase II study of vismodegib in patients with advanced BCC. The results were presented at the Seventh European Association of Dermato-Oncology (EADO) Congress in July 2011 as well as at the European Multidisciplinary Cancer Congress (EMCC) in September 2011.

About Basal Cell Carcinoma

BCC is the most common cancer in Europe and the United States. The disease is generally considered curable when the cancer is restricted to a small area of the skin. However, in a small group of people, if the disease is left untreated or does not respond to treatment, the cancer may advance further into the skin, bones or other tissues, or spread to other parts of the body. In such rare cases, the disease can become difficult to treat and life-threatening. There are no approved therapies to treat advanced basal cell carcinoma.

1 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr 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

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

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
SYM TRADE IT LAST %CHG

Markets

Chart of I:DJI
DOW 16,654.77 +369.26 2.27%
S&P 500 1,987.66 +47.15 2.43%
NASDAQ 4,812.7080 +115.1720 2.45%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs