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NovaBay Pharmaceuticals Provides Fourth Quarter And Full Year 2010 Financial Results And Business Unit Updates

Stocks in this article: NBY

"We further advanced on our goal of building business units based upon the Aganocide anti-infective platform in four distinct therapeutic areas: dermatology, ophthalmology, urology and hospital infections. Each of these market segments offers substantial revenue potential. NovaBay's hybrid strategy is to address these market opportunities either through partnerships and collaborations, which effectively minimizes our commercialization risk, or by building an internal organization to strategically market our own products when appropriate from a commercial standpoint," Dr. Ron Najafi, concluded.

Recent Highlights

2010 Highlights

  • December 2010 - Received $3.25 million from Galderma for the expansion of the multi-year collaboration agreement to include impetigo. The agreement increases potential milestones to $62 million plus double-digit royalties on future sales.
  • November 2010 - Held successful meeting with the FDA on the Company's clinical development plans for Aganocide compound NVC-422 for the treatment of impetigo. NovaBay management and representatives from the FDA discussed timing for additional studies, trial design, and NDA plan for Impetigo. 
  • October 2010 - Demonstrated up to 92% efficacy in 129 patient Impetigo Phase 2 clinical trial, including 100% efficacy in MRSA infected patients. The results were highlighted at the 48th Annual Infectious Disease Society of America Meeting in Vancouver, B.C., which also provided the Company with a platform to announce additional confirmatory studies of NVC-422's nail penetration and anti-fungal capabilities in onychomycosis. 
  • October 2010 - Appointed Gail Maderis, BayBio President and CEO, former CEO of Five Prime Therapeutics and Genzyme Senior Executive, to its Board of Directors. Over 20 years of senior-level healthcare experience adds significant depth to NovaBay's Board.
  • July 2010 - Received notice of allowance on Anti-Infective NVC-612 and related compounds. The patent will cover compositions of matter and methods of use for NVC-612 and related compounds, all of which have a unique mechanism of action toward microorganisms. The new patent complements NovaBay's existing collection of more than 20 patents and pending patent applications on its proprietary technology platforms.   
  • May 2010 - Completed enrollment in Phase 2a proof of concept clinical trial for the treatment of impetigo. The double-blind, randomized, sequential group study evaluated the safety and efficacy of NVC-422, in 129 patients ages 2 to 12 at clinical centers in the Dominican Republic. NovaBay's partner in the trial is Galderma S.A., one of the world's leading dermatology companies.
  • April 2010 - Presented positive data on NVC-422 at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting in Ft. Lauderdale, Florida. Alcon, NovaBay's partner for Ophthalmology, and NovaBay scientists presented 3 scientific posters that confirm stability and antiviral activity of NovaBay's Aganocide Compounds.  
  • March 2010 - Reported positive data from exploratory Phase 2 clinical trial for Urinary Catheter Blockage and Encrustation (UCBE). In-house, un-partnered study showed that NovaBay's lead Aganocide compound, NVC-422 was well tolerated and reduced or eliminated certain pathogens in the urine.
  • January 2010 - Received $3.75 million from Galderma S.A. in connection with achieving clinical and formulations milestones.

About NovaBay Pharmaceuticals, Inc.

NovaBay Pharmaceuticals is a clinical-stage biotechnology company focused on developing its proprietary and patented Aganocide compounds.  These are novel, synthetic anti-infectives with activity against bacteria, fungi and viruses, and are being developed to treat and prevent a wide range of local, non-systemic infections with a low likelihood of developing bacterial resistance.

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