NVC-422 is a novel anti-infective with broad-spectrum bactericidal activity and novel mechanism of action to address the unmet medical needs in several large markets. The compound has been shown to be highly effective in vitro against multi-drug resistant bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus (VRE). Different topical formulations of NVC-422 are in mid-to-late-stage clinical development in ophthalmology, dermatology and urology.About NovaBay Pharmaceuticals, Inc. ( www.novabaypharma.com ) Going Beyond Antibiotics NovaBay Pharmaceuticals is a clinical-stage biotechnology company focused on addressing the large unmet therapeutic needs of the global anti-infective market with its two distinct categories of products. Aganocide ® Compounds NovaBay's first-in-class Aganocide compounds, led by NVC-422, are patented, 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, which is critical for advanced anti-infectives. 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. 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. A major global clinical study is planned for 2012.
- 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 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) and associated urinary tract infections. The Company reported positive data from Part A of this study and expects to announce top-line results from Part B later in 2012.
CONTACT: NovaBay Business Development and Licensing: Roy J. Wu Sr. VP Business Development (510) 899-8815 BusDev@novabaypharma.com Investors: NovaBay Pharmaceuticals, Inc. Thomas J. Paulson Chief Financial Officer 510-899-8809 tjpaulson@NovaBaypharma.com Investors and Media: The Ruth Group Nicole Greenbaum (Investors) (646) 536-7009 firstname.lastname@example.org Victoria Aguiar (Media) (646) 536-7013 email@example.com