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NovaBay Pharmaceuticals, Inc.

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NovaBay Pharmaceuticals Reports Activity of New Drug Against Deadly “Superbug”


NovaBay recently announced that in tests conducted at a third-party laboratory, its experimental drug NVC-422 showed in vitro activity against NDM-1.

San Francisco, CA, January 13, 2011 --(PR.com)-- Seventy percent of infections in the US are now drug resistant, and the list of bacteria that resist commonly prescribed antibiotics is growing steadily. The latest nail in the coffin of traditional antibiotics is the rise of “superbugs” such as NDM-1, actually a gene that enables bacteria to produce an enzyme that disables antibiotics.

NovaBay Pharmaceuticals, a clinical stage biotechnology company developing anti-infective compounds called Aganocides to treat and prevent antibiotic-resistant infections, recently announced that in tests conducted at a third-party laboratory, its experimental drug NVC-422 showed in vitro activity against NDM-1. In comparison, Imipenem, a mainstay antibiotic for the treatment of antibiotic-resistant bacterial infections, is not effective against NDM-1. NovaBay intends to publish and present the full data set at the upcoming Interscience Conference on Antimicrobial Agents and Chemotherapy.

K. pneumoniae and E. coli have been identified as a cause of severe infections, sepsis and possibly death. In a number of areas of interest to NovaBay, both these superbugs are major risk factors. These include catheter-associated urinary tract infections (UTIs); respiratory tract infections, including those caused by cystic fibrosis; and wound infections, including venous stasis, pressure ulcers and diabetic ulcers.

Dr. Ron Najafi, CEO of NovaBay, said, “We were very excited to see the in vitro activity results of NVC-422 against NDM-1 strains. In fact, we have collected data indicating that NVC-422 is also effective in vitro against six highly resistant pathogens—Enterococcus faecium, Staphylococcus aureus, Klebsiella species, Acinetobacter baumannii, Pseudomonas aeruginosa and Enterobacter—which are the cause of much of the hospital-associated infections today. We intend to translate this activity into products that will benefit patients in need. Both UTI and chronic non-healing wounds will be the future breeding ground for NDM-1-producing bacteria.”

NovaBay is currently engaged in a Phase 2 human trial for urinary catheter blockage and encrustation leading to urinary tract infections, and the company and its partner Galderma S.A. are engaged in the clinical development of its lead compound for the treatment of impetigo, a highly contagious infection with potential benefit in chronic wound care management.

About the NDM-1 gene
NDM-1 is an enzyme that makes bacteria resistant to a broad range of beta-lactam antibiotics. These include the antibiotics of the carbapenem family, which are a mainstay for the treatment of antibiotic-resistant bacterial infections. The gene for NDM-1 is one member of a large gene family that encodes beta-lactamase enzymes called carbapenemases. Bacteria that produce carbapenemases are often referred to in the news media as “superbugs” because infections caused by them are difficult to treat.

NDM-1 was first detected in a Klebsiella pneumoniae isolate from a Swedish patient of Indian origin in 2008. It was later detected in bacteria in India, Pakistan, the United Kingdom, the United States, Canada, Japan and Brazil. The most common bacteria that make this enzyme are Gram negative such as Escherichia coli and Klebsiella pneumoniae, but the gene for NDM-1 can spread from one strain of bacteria to another by horizontal gene transfer.

About Aganocides
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 topical 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 topical 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 topical 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, 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, visit www.novabaypharma.com.

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Contact Information
NovaBay Pharmaceuticals, Inc.
Janet Vasquez
212-825-3210
Contact
www.novabaypharma.com

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