Durata receives positive EMA Scientific Advice on dalbavancin clinical development plan

Durata Therapeutics today announced the Company has received positive Scientific Advice from the European Medicines Agency (EMA) on the pivotal clinical development plan for dalbavancin, Durata's long-acting, intravenous (IV) lipoglycopeptide for the treatment of acute bacterial skin and skin structure infections (abSSSI). The EMA's Advice is in concert with the output of a Special Protocol Assessment (SPA) agreed upon with the U.S. Food and Drug Administration (FDA). Based on this comprehensive body of regulatory guidance, Durata is conducting a global, pivotal, Phase 3 study (DISCOVER-1) of dalbavancin, initiated in March of this year.

Mark Wilcox, M.D., Head of Microbiology and Clinical Director of Pathology for the Leeds Teaching Hospitals, and Professor of Medical Microbiology for the University of Leeds, UK, said, "Antibiotic resistance is growing markedly across Europe, both in hospitals and the community. There is a need for new agents that fit with modern healthcare delivery and can address a broad spectrum of pathogens, including, for instance, community-acquired methicillin-resistant Staphylococcus aureus (MRSA). The previous clinical data for dalbavancin are highly promising, and I look forward to further progress of this program."

"The EMA Scientific Advice and FDA SPA agreement ensure that we have a clear regulatory path forward in the major regions where the pivotal program is being conducted," stated Durata's Chief Medical Officer, Michael Dunne, M.D. "We expect that a significant percentage of patient enrollment will come from sites in Europe. The inclusion of patients from the U.S., European Union member states and Eastern Europe will ensure that the clinical trial data we generate will be relevant to the patient populations who will ultimately benefit from its introduction to healthcare formularies."

Dr. Dunne continued, "Dalbavancin has demonstrated unique attributes, including the convenience of once-a-week dosing and 30-minute infusion time, that we believe will distinguish dalbavancin from other therapies. We anticipate that pivotal, late-stage studies, initiated recently will provide confirmation of these and other key characteristics of this promising agent."

Durata recently announced the initiation of a global, pivotal, Phase 3 study (DISCOVER-1) of dalbavancin, which is being conducted after a SPA was agreed upon with FDA. The trial is a randomized, double-blind, double-dummy study designed to compare the efficacy and safety of dalbavancin to vancomycin, with patients randomized to vancomycin allowed to switch to oral linezolid after three days of IV vancomycin therapy. The study is expected to enroll approximately 556 patients worldwide.