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
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

Vertex Announces Initiation Of Pivotal Phase 3 Program Of VX-809 In Combination With Ivacaftor For The Treatment Of People With Cystic Fibrosis Who Have Two Copies Of The F508del Mutation

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the initiation of a global pivotal Phase 3 development program for fixed-dose combinations of VX-809 (lumacaftor) and ivacaftor in people with cystic fibrosis (CF) who have two copies (homozygous) of the F508del mutation in the cystic fibrosis transmembrane conductance regulator ( CFTR) gene. Vertex plans to conduct two 24-week Phase 3 studies to support approval of the combination of VX-809 and ivacaftor in people with CF ages 12 and older. The studies, TRAFFIC and TRANSPORT, will each include two treatment groups that will evaluate VX-809 (600mg QD or 400mg q12h) in combination with ivacaftor (250mg q12h) compared to a placebo group. Vertex expects to obtain 24-week safety and efficacy data from both studies and to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA), pending study results.

Vertex also plans to conduct a pharmacokinetics and safety study to evaluate VX-809 in combination with ivacaftor in children with CF ages 6 to 11 who have two copies of the F508del mutation. The company expects to use the data from this study for subsequent registration in children ages 6 to 11 in the United States and is continuing discussions with European regulatory agencies for patients in this age group.

Vertex will host a conference call for investors and media today, February 26, 2013 at 5:15 p.m. EST, to discuss the company’s Phase 3 development plan.

“This Phase 3 development program is a significant advance in our efforts to develop new medicines that treat the underlying cause of cystic fibrosis for people with the most common type of the disease,” said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer at Vertex. “Importantly, these studies will evaluate two doses of VX-809 in combination with ivacaftor for 24 weeks, and pending data, enable submissions to U.S. and European regulatory authorities. People with CF are in urgent need of new treatments, and we are committed to advancing this combination through Phase 3 development as quickly as possible.”

1 of 7

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 17,065.78 +86.65 0.51%
S&P 500 1,993.30 +6.79 0.34%
NASDAQ 4,531.4180 +4.9360 0.11%

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