CHICAGO, IL, USA I December 3, 2013 I Durata Therapeutics, Inc. (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 cm2 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(TM) (dalbavancin hydrochloride) with an action date of May 26, 2014, which was announced on November 26, 2013.

ABOUT DALBAVANCIN

Dalbavancin is a second generation, semi-synthetic lipoglycopeptide, which consists of lipophilic side-chains attached to glycopeptides. When compared to vancomycin, dalbavancin has a longer half-life resulting in a duration of antibacterial activity of 5-7 days per dose.i If approved by EMA, dalbavancin would be the first drug for cSSTI requiring only two once-weekly 30-minute intravenous doses (1000 mg on Day 1 and 500 mg on Day 8). This may shorten the length of stay for patients who are hospitalized and, for appropriate patients, enable therapy in an outpatient setting eliminating the hospital admission altogether.ii Ultimately, this may lower the overall cost of care for these patients.

ABOUT DURATA THERAPEUTICS, INC.

Durata Therapeutics, Inc. is a pharmaceutical company focused on the development and commercialization of novel therapeutics for patients with infectious diseases and acute illnesses. Durata has completed two global Phase 3 clinical trials with its lead product candidate, dalbavancin, for the treatment of patients with complicated skin and soft tissue infections, or cSSTI (or, in the US, acute bacterial skin and skin structure infections — ABSSSI).

SOURCE: Durata Therapeutics