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Durata Therapeutics Announces
Dalbavancin Production Capabilities and Signing of Global Manufacturing
AgreementMORRISTOWN, N.J. --(BUSINESS WIRE)-- June 06, 2011 --Durata Therapeutics today announced the successful production of clinical supplies of dalbavancin, the Company’s lead product, at two top-tier manufacturing facilities. Durata also announced the signing of a global, multi-year agreement with one of these manufacturers. Dalbavancin is a long-acting, intravenous (IV) lipoglycopeptide for the treatment of acute bacterial skin and skin structure infections (abSSSI). Additional details of the agreements were not disclosed. Paul R. Edick, Chief Executive Officer of Durata, commented, "Ensuring multiple sources of product at all levels of the supply chain increases our flexibility and reduces risk. We now have produced supplies of drug for clinical testing at two facilities, allowing us to further accelerate our lead program towards potential launch and commercialization." In March, Durata announced the initiation of a global, pivotal, Phase 3 study (DISCOVER-1) of dalbavancin, which is being conducted under a Special Protocol Assessment (SPA) agreed upon with the U.S. Food and Drug Administration (FDA). The study also received positive Scientific Advice from the European Medicines Agency (EMA). 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. Durata’s Chief Medical Officer, Michael Dunne, M.D., stated, "Dalbavancin is one of the most advanced of the next-generation lipoglycopeptides, in the same class as vancomycin. Due to its unique features and PK profile, dalbavancin offers the significant convenience of once-a-week dosing and short, 30-minute infusion time. Based on these characteristics, the safety data in over 1300 patients, and our expectations for the pivotal program, we believe this product has the potential to set the bar for activity against important Gram-positive bacterial infections, including those due to methicillin-resistant Staphylococcus aureus (MRSA)." To learn more about Durata’s ongoing pivotal study for dalbavancin, please visit click here. 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. 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. Contacts Media Burns McClellan Justin Jackson (Media) 212-213-0006 jjackson @burnsmc.com or Business Development Durata Therapeutics Corey Fishman Chief Operating Officer 973-993-4865 cfishman @duratatherapeutics.com |