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Business Description

Durata Therapeutics Inc was incorporated under the laws of the State of Delaware on November 4, 2009. It is a pharmaceutical company focused on the development and commercialization of novel therapeutics for patients with infectious diseases and acute illnesses. The Company is currently enrolling and dosing patients in two global Phase 3 clinical trials with its lead product candidate, dalbavancin, for the treatment of patients with acute bacterial skin and skin structure infections, or abSSSI. It is conducting each of these Phase 3 clinical trials pursuant to special protocol agreements, or SPAs, with the U.S. Food and Drug Administration, or FDA, based on draft guidance issued by the FDA in 2010 for the development of drugs to treat abSSSI. It also designed these trials based on scientific advice that it received from the European Medicines Agency, or EMA, in December 2010 to meet the regulatory filing requirements in the European Union. It expects to complete these Phase 3 clinical trials and have initial, top-line data available in the beginning of 2013. Dalbavancin is an intravenous antibiotic product candidate designed for once-weekly dosing. The dalbavancin's once-weekly dosing will facilitate the treatment of patients with abSSSI in both the in-patient and out-patient settings by reducing the length of a patient's hospital stay or avoiding hospital admission altogether and, ultimately, lowering the overall cost of care for these patients. Dalbavancin's pharmacokinetic profile, which reflects the absorption, distribution and metabolism of a drug in the body, and its relatively long half-life compared to many currently available treatments result in continuous bactericidal, or bacteria killing, activity over a prolonged period of time following treatment. Dalbavancin is a second generation, semi-synthetic lipoglycopeptide designed for once-weekly intravenous dosing. It is initially developing dalbavancin for the treatment of patients with abSSSI caused by Gram-positive bacteria, such as S. aureus, including Methicillin-Resistant and multi-drug resistant strains, and certain Streptococcal species.
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Industry:	Biotechnology
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