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Durata Therapeutics Submits Marketing Authorization Application For Dalbavancin

CHICAGO, Dec. 3, 2013 (GLOBE NEWSWIRE) -- Durata Therapeutics, Inc. (Nasdaq:DRTX) today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for dalbavancin seeking approval for the marketing and sale of dalbavancin for the treatment of patients with complicated skin and soft tissue infections (cSSTI) caused by susceptible Gram-positive microorganisms, including Staphylococcus aureus (including methicillin-resistant strains) and Streptococcus pyogenes, as well as certain other streptococcal species. Following the standard EMA review cycle timing, the Company anticipates a decision in 1H2015.

"The EMA marketing authorization application submission is an important milestone in the development of dalbavancin. If approved, dalbavancin will be the first drug for cSSTI with unique once-weekly dosing given in a short, 30-minute IV infusion time, which may help reduce the overall burden of care without sacrificing patient outcome," said Paul R. Edick, Durata Therapeutics' Chief Executive Officer. "In the US, there is a focus on optimizing the location of treatment and clinical outcomes, as well as controlling the cost of IV antibiotic delivery. We believe a similar shift will take place in Europe in the next few years. With a long-acting, once weekly IV antibiotic treatment option, there may be a dramatic potential savings in terms of total cost of care when compared to daily IV antibiotic delivery." 

The submission included results from the two Phase 3 trials, DISCOVER 1 and DISCOVER 2, as well as a previous Phase 3 study (VER001-9). In the DISCOVER trials, cSSTI was defined as cellulitis, wound infection, or major cutaneous abscess with an associated area of surface erythema measuring at least 75 cm 2 accompanied by at least two other local signs of infection and at least one of the following systemic signs of infection: fever, leukocytosis, or increased immature neutrophils.

The EMA submission follows the US Food and Drug Administration's (FDA) acceptance for priority review of the New Drug Application (NDA) for Dalvance™ (dalbavancin hydrochloride) with an action date of May 26, 2014, which was announced on November 26, 2013. 

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