Company is Poised for Continued Studies of NVC-422 for Treatment of Impetigo; Timing for Additional Studies and NDA Plan Discussed
EMERYVILLE, Calif., Nov. 29, 2010 (GLOBE NEWSWIRE) -- NovaBay Pharmaceuticals, Inc. (NYSE Amex:NBY), a clinical stage biotechnology company developing first-in-class, anti-infective compounds for the treatment and prevention of antibiotic-resistant infections, announces a successful meeting with the US Food and Drug Administration (FDA) to discuss the Company's clinical development of its Aganocide® compound NVC-422, intended for use in the treatment of impetigo.
"We had a very positive meeting with the FDA on our clinical development of NVC-422 for impetigo. The FDA provided valuable input on the design of our Phase 2b trial, timing of additional clinical and other studies needed for a New Drug Application (NDA)," said Ron Najafi, Ph.D, NovaBay's Chairman and CEO. "We are moving forward to implement the FDA's suggestions."
NovaBay recently reported positive results for the use of NVC-422 topical gel in the treatment of impetigo from a 129 patient, randomized, double-blind, dose-ranging Phase 2a clinical trial. The trial showed high clinical and bacteriological efficacy of three concentrations of the drug applied ranging from 84% to 95% at end of treatment and at follow up. These response rates compare favorably to previously published results from studies of topical antibiotics, and were substantially higher than the response rate (30-50%) anticipated for placebo. The treatment was well tolerated with the few adverse events reported being mild to moderate in severity and all resolved after the end of treatment. Additionally, the response rate for all patients infected with MRSA who completed treatment was 100%.
Impetigo is a highly contagious superficial bacterial infection of the skin that afflicts approximately 1 million people, primarily infants and children, in the United States annually. Most cases are caused by Staphylococcus aureus, Streptococcus pyogenes, or a mixture of both organisms. Methicillin-resistant S. aureus (MRSA) is being found with increasing frequency in this population. Impetigo is currently being treated with antibiotic ointments, to which bacteria may develop resistance. A recent proof of concept study provided compelling evidence of the activity of NVC-422 topical gel in the treatment of impetigo in children.
NovaBay's Aganocide® compounds are novel, synthetic N-chlorinated antimicrobial molecules specifically designed and developed to mimic the body's natural defense against infection. The Aganocide compounds maintain biological activities while demonstrating improved stability over the naturally occurring N-chlorinated antimicrobial molecules. In preclinical testing, NovaBay's Aganocide compounds have been shown to be highly effective against bacteria, including some multi-drug resistant strains (such as MRSA), viruses and fungi. NovaBay's Aganocide compounds have the potential to deliver the same or better efficacy than antibiotics, and to address the growing problem of antibiotic resistance by employing a novel mechanism of action.
About NovaBay Pharmaceuticals, Inc.
NovaBay Pharmaceuticals is a clinical stage biotechnology company focused on developing its proprietary and patented Aganocide compounds, which are novel, synthetic, anti-infective product candidates with equivalent activity to the active antimicrobial molecules generated within white blood cells. NovaBay's Aganocide compounds are being developed to treat and prevent a wide range of infections without causing bacterial resistance. NovaBay has internal development programs aimed at addressing hospital infections, chronic non-healing wounds, urinary catheter blockage and encrustation (UCBE) and onychomycosis. The company has a license and research collaboration agreement with Alcon, Inc. for use of its Aganocide compounds to treat eye, ear and sinus infections as well as for contact lens care. NovaBay has also entered into an agreement with Galderma S.A. to develop and commercialize Aganocide compounds in acne, impetigo and other dermatological indications. For more information on NovaBay, visit: www.novabaypharma.com.
Cautionary Information Regarding Forward-Looking Statements
The statements in this press release of NovaBay's expectations and potential regarding its Aganocide compounds including Aganocide's future potential to treat broad range of infections without causing resistance are forward-looking statements. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, among others, the risk that results obtained in preclinical studies may not be obtained in humans, and the risk that the Aganocide compounds may not deliver the same or better efficacy than currently used antibiotics without contributing to the growing rise of bacterial resistance. Other risks relating to NovaBay and its Aganocide compounds, including risks that could cause results to differ materially from those projected in the forward-looking statements in this press release, are detailed in NovaBay's Quarterly Report on Form 10-Q for the period ended September 30, 2010, under the caption "Risk Factors" in Item 1A of Part II of that report, filed with the Securities and Exchange Commission on November 12, 2010. 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: NovaBay Pharmaceuticals, Inc. Investors: Thomas J. Paulson, Chief Financial Officer 510-899-8800 firstname.lastname@example.org The Investor Relations Group Investor Relations: Adam Holdsworth 212-825-3210 email@example.com Public Relations: Laura Colontrelle 212-825-3210 firstname.lastname@example.org