This Day On The Street
Continue to site right-arrow
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!

NovaBay Pharmaceuticals (NBY) Receives $2.6 Million From Partner Galderma

Stocks in this article: NBY

Marks Advancement of Aganocide ® NVC-422 Clinical Program for Impetigo Treatment

EMERYVILLE, Calif., Sept. 26, 2012 (GLOBE NEWSWIRE) -- NovaBay ® Pharmaceuticals, Inc. (NYSE:NBY), a biotechnology company focused on addressing the large unmet therapeutic needs of the global anti-infective market with first-in-class compounds such as its proprietary Aganocides ® , today announced that it has received $2.6 million from partner Galderma S.A., a global leading pharmaceutical company exclusively focused on dermatology. The payment is associated with the clinical advancement of NovaBay's "non-antibiotic, anti-infective" Aganocide ® compound NVC-422 as a topical formulation moving to replace traditional antibiotics for the impetigo treatment, a highly contagious skin infection caused by common bacteria such as methicillin-resistant Staphylococcus aureus (MRSA).

Under the terms of an exclusive licensing agreement, Galderma is responsible for the ongoing clinical development program for NVC-422 for impetigo, among other indications, and NovaBay will receive escalating double-digit royalties on net sales of products. The agreement is worldwide in scope and covers potentially all major dermatological conditions. NovaBay has retained rights to certain Asian markets, onychomycosis (nail fungus), post surgical use and use in wound care, and orphan drug indications. NovaBay has retained all rights in other Asian markets outside Japan, and has exclusive rights to promote the products developed under the agreement in hospitals and other healthcare institutions in North America.

Galderma and NovaBay recently announced on September 24, 2012 the first patients enrolled in the Phase 2b global trial for impetigo treatment, which according to the Food and Drug Administration (FDA) has all the design elements (controls, sample size, end-points) to be considered a pivotal trial. Results from this clinical trial are expected in the first half of 2013.

About NovaBay Pharmaceuticals, Inc.

Going Beyond Antibiotics

NovaBay Pharmaceuticals is a biotechnology company focused on addressing the large unmet therapeutic needs of the global anti-infective market with its two distinct categories of compounds, Aganocides® and NeutroPhase® Skin & Wound Cleanser. The Company's four core business units, DermaBay, UroBay, EyeBay and MediBay, are developing treatments that tackle infections in the dermatology, urology, ophthalmology and wound care areas.

Aganocide ® Compounds

NovaBay's first-in-class Aganocide compounds, led by NVC-422, are patented, synthetic Aganocides, proprietary to NovaBay, are non-systemic "non-antibiotics, anti-infective" topical compounds involving synthetic molecules with a broad spectrum of activity against bacteria, viruses and fungi. Mimicking the mechanism of action that human white blood cells use against infections, Aganocides possess a reduced likelihood that bacteria or viruses will be able to develop resistance, critical characteristic for advanced anti-infectives in today's environment. Having demonstrated therapeutic proof-of-concept in three Phase 2 clinical studies, these compounds are suited to treat and prevent a wide range of local, non-systemic infections involving the skin, eye, bladder and may have potential for other opportunities such as sinus, lung and nail infections. NovaBay is currently concentrated on three large therapeutic markets:

  • Dermatology - Partnered with Galderma, a leading dermatology company, to develop a formulation of NVC-422 for treatment of highly contagious skin infection, impetigo. Current product offerings give rise to resistance. Enrollment in a major global Phase 2b/3 clinical study began on September 24, 2012 with top-line data expected in the first half of 2013.  
  • Ophthalmology - NovaBay is developing an eye drop formulation of NVC-422 for treating viral conjunctivitis, for which there is currently no FDA-approved treatment. Enrollment into a global Phase 2b/3 clinical study has begun with top-line data expected in the first half of 2013.  
  • Urology – NovaBay's irrigation solution containing NVC-422 is currently in Phase 2 clinical studies, with the goal of reducing the incidence of urinary catheter blockage and encrustation (UCBE). The Company reported positive data from Part A of this study and expects to announce top-line results from Part B later in the first half of 2013.

NeutroPhase ®

NeutroPhase Skin and Wound Cleanser is the only patented pure hypochlorous acid (HOCI) cleared by the U.S. Food and Drug Administration (FDA) to target the six-million-patient U.S. market of chronic non-healing wounds, such as pressure, venous stasis and diabetic ulcers. The saline based solution is the only skin and wound cleanser available to include a stabilized, pure form HOCI shown in studies to kill bacteria in solution, including necrotizing fasciitis. For additional information, visit: .

Stay informed on NovaBay's progress:

Cautionary Information Regarding Forward Looking Statements

The statements in this press release regarding NovaBay's expectation regarding its partnership with Galderma and bringing products to market for dermatological indication; NovaBay's expectation on the potential efficacy of Aganocide compounds for the treatment of impetigo and other indications; any potential plans for future clinical development of NVC-422; the expected timing of enrollment and commencement of clinical trials, expected timing of receipt and announcement of results of clinical studies, and efficacy of NeutroPhase and Aganocides are forward-looking statements subject to risks and uncertainties. Actual results may be different from those that NovaBay expects due to a number of factors, including risk that negative results from the development program could preclude Galderma from providing additional funding to NovaBay, risks and uncertainties in obtaining regulatory approvals for NovaBay's products, as well as other risks relating to NovaBay, its NeutroPhase and Aganocide compounds detailed in NovaBay's Form 10-K and Form 10-Q filings with the Securities and Exchange Commission, especially under the heading "Risk Factors." The forward-looking statements in this release speak only as of this date, and NovaBay disclaims any intent or obligation to revise or update publicly any forward-looking statement except as required by law.

CONTACT: Investors:
         NovaBay Pharmaceuticals, Inc.
         Thomas J. Paulson
         Chief Financial Officer
         Investors and Media:
         The Ruth Group
         Nicole Greenbaum (Investors)
         (646) 536-7009
         Victoria Aguiar (Media)
         (646) 536-7013

Select the service that is right for you!

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 17,804.80 +26.65 0.15%
S&P 500 2,070.65 +9.42 0.46%
NASDAQ 4,765.38 +16.9840 0.36%

Brokerage Partners

Rates from

  • 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