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Global Study to Enroll Patients in Four Countries Worldwide
LAUSANNE, Switzerland and EMERYVILLE, Calif., Sept. 24, 2012 (GLOBE NEWSWIRE) -- Galderma S.A., a global leading pharmaceutical company exclusively focused on dermatology and NovaBay Pharmaceuticals, Inc. (NYSE MKT:NBY), a biotech company developing novel anti-infective products for the treatment and prevention of topical infections, including those caused by antibiotic-resistant bacterial strains, today announced that the first patients have been enrolled in the Companies' Phase 2b clinical study of a proprietary topical formulation of NVC-422 (CD07223) for the treatment of impetigo. The study is expected to enroll over 300 patients at 24 clinical sites in four countries worldwide and aims to confirm efficacy and evaluate 2 different dosage regimens.
"We are pleased with the Phase 2b study launch and our continuous progress with our partner NovaBay. We are highly committed to developing this exciting and differentiated product candidate for the treatment of impetigo," said Humberto C. Antunes, Chief Executive Officer of Galderma. "We share NovaBay's enthusiasm for NVC-422, and together we expect to advance this program through late-stage clinical development, and potential approval and commercialization."
"If successful, NVC-422 will be the first "non-antibiotic anti-infective" moving to replace traditional antibiotics in the treatment of impetigo. I commend both development teams at NovaBay and Galderma on our very successful collaboration and their efforts in bringing this product closer to the finish line," said Dr. Ron Najafi, Chairman and Chief Executive Officer of NovaBay.
In further support of product registration, Galderma has established preclinical and clinical safety for topical NVC-422, including the successful completion of safety studies involving more than 300 healthy volunteers, as well as the feasibility of manufacturing scale-up and long-term shelf-life. As announced previously, following an End of Phase 2a meeting with the Food and Drug Administration (FDA) attended by both Companies, valuable guidance from the FDA has been incorporated into the Phase 2b protocol.