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

RedHill Biopharma Announces Positive European Scientific Advice Meeting Regarding RHB-102 And Plans To Submit A European Marketing Application

  • The Company concluded a positive scientific advice meeting with the UK MHRA regarding RHB-102 and plans to submit, during the second half of the year, a European marketing application for the prevention of chemotherapy and radiotherapy-induced nausea and vomiting in cancer patients
  • RHB-102 is a proprietary, once-daily, oral pill formulation of the anti-emetic oncology support drug ondansetron
  • The Company commenced a comparative bioavailability study with RHB-102 to support its planned European marketing application, with study results expected by July 2014
  • In addition to the currently pursued indications, the MHRA provided guidance regarding a new undisclosed indication which may significantly expand RHB-102's potential market; A Phase III study for this indication is planned in the U.S. for later this year

TEL-AVIV, Israel, April 7, 2014 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) (the "Company" or "RedHill"), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, proprietary drugs for the treatment of inflammatory and gastrointestinal diseases and related conditions, today announced that it had concluded a positive European scientific advice meeting with the UK Medicines and Healthcare Products Regulatory Agency (MHRA) regarding RHB-102, a proprietary, extended-release (once-daily) oral pill formulation of the anti-emetic oncology support drug ondansetron for the prevention of chemotherapy and radiotherapy-induced nausea and vomiting ("CINV" and "RINV" respectively).

In light of the positive feedback from the UK MHRA, RedHill intends to submit, during the second half of the year, a Marketing Authorization Application (MAA) in Europe with the UK as the reference EU member state for the European Mutual Recognition Procedure (MRP).

To support the planned MAA submission, RedHill has commenced a comparative bioavailability study comparing RHB-102 to the European reference drug. The two-arm crossover comparative bioavailability study includes 20 healthy volunteers and is intended to explore the relative bioavailability between RHB-102 and GlaxoSmithKline's European reference drug. The secondary objective of the study is to further assess the safety and tolerability of RHB-102.

1 of 2

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 17,156.85 +24.88 0.15%
S&P 500 2,001.57 +2.59 0.13%
NASDAQ 4,562.1890 +9.43 0.21%

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