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

Galderma And NovaBay Enroll First Patients In Phase 2b Clinical Study Of NVC-422 For Impetigo

Stocks in this article: NBY

Global Study to Enroll Patients in Four Countries Worldwide

LAUSANNE, Switzerland and EMERYVILLE, Calif., Sept. 24, 2012 (GLOBE NEWSWIRE) -- Galderma S.A., a global leading pharmaceutical company exclusively focused on dermatology and NovaBay Pharmaceuticals, Inc. (NYSE MKT:NBY), a biotech company developing novel anti-infective products for the treatment and prevention of topical infections, including those caused by antibiotic-resistant bacterial strains, today announced that the first patients have been enrolled in the Companies' Phase 2b clinical study of a proprietary topical formulation of NVC-422 (CD07223) for the treatment of impetigo. The study is expected to enroll over 300 patients at 24 clinical sites in four countries worldwide and aims to confirm efficacy and evaluate 2 different dosage regimens.

"We are pleased with the Phase 2b study launch and our continuous progress with our partner NovaBay. We are highly committed to developing this exciting and differentiated product candidate for the treatment of impetigo," said Humberto C. Antunes, Chief Executive Officer of Galderma. "We share NovaBay's enthusiasm for NVC-422, and together we expect to advance this program through late-stage clinical development, and potential approval and commercialization."

"If successful, NVC-422 will be the first "non-antibiotic anti-infective" moving to replace traditional antibiotics in the treatment of impetigo. I commend both development teams at NovaBay and Galderma on our very successful collaboration and their efforts in bringing this product closer to the finish line," said Dr. Ron Najafi, Chairman and Chief Executive Officer of NovaBay. 

In further support of product registration, Galderma has established preclinical and clinical safety for topical NVC-422, including the successful completion of safety studies involving more than 300 healthy volunteers, as well as the feasibility of manufacturing scale-up and long-term shelf-life. As announced previously, following an End of Phase 2a meeting with the Food and Drug Administration (FDA) attended by both Companies, valuable guidance from the FDA has been incorporated into the Phase 2b protocol.

1 of 3

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!

Markets

DOW 17,685.80 +328.93 1.90%
S&P 500 2,049.14 +36.25 1.80%
NASDAQ 4,729.6280 +85.3160 1.84%

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