MORRISTOWN, N.J.--()--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.
“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.”
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.
To learn more about Durata’s pivotal study for dalbavancin, please visit http://clinicaltrials.gov/ct2/show/NCT01339091?term=dalbavancin&rank=2.
About Scientific Advice
Scientific Advice is a procedure offered by the EMA to stakeholders for clarification of questions arising during development of medicinal products. The scope of Scientific Advice received from EMA is limited to scientific issues, i.e. to quality, non-clinical and clinical aspects of the concerned medicinal product not yet unequivocally covered by published scientific guidelines. Scientific Advice focuses on development strategies rather than pre-evaluation of data to support a Marketing Authorization Application. Scientific Advice is legally non-binding and is based on the current scientific knowledge which may be subject to future changes.
About Durata Therapeutics
Durata Therapeutics is a biopharmaceutical company addressing the growing need for new therapeutics to treat infectious diseases. Durata’s current late-stage clinical product, dalbavancin, is a next-generation lipoglycopeptide with unique features, including convenient, once-a-week dosing. To date, dalbavancin has been shown to be effective and well-tolerated in late-stage clinical trials of patients with skin infections, supported by a promising safety profile based on clinical data in over 1300 patients. Durata has worldwide rights for the development and commercialization of dalbavancin. The Company also has two antibiotic programs in earlier-stage, preclinical research.
Durata’s senior leadership has considerable experience in running healthcare companies and broad expertise in medical affairs, operations, manufacturing and commercialization, including multiple U.S. and global product launches. Durata is supported by a premier team of venture capital organizations including New Leaf Venture Partners, LLC, Domain Associates, LLC, Aisling Capital, Sofinnova Ventures Inc. and Canaan Partners.
For more information on Durata and the Company’s programs, please visit www.duratatherapeutics.com.