DRTX (MM)

Durata Therapeutics, Inc. (Nasdaq:DRTX) today announced that data from two Phase 3 clinical trials of the company's lead product candidate, dalbavancin, will be presented in two posters at the 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Denver, September 10-13, 2013. The trials were conducted via a Special Protocol Assessment based on the FDA's Draft Guidance for Developing Drugs for the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI). Dalbavancin is under investigation for the treatment of ABSSSI caused by susceptible Gram-positive microorganisms. These data will be used to support the company's anticipated submission of a New Drug Application to the U.S. Food and Drug Administration at the end of September 2013.

In addition, R.M. Alden Research Lab will present in vitro data regarding the activity of dalbavancin against isolates obtained from osteomyelitis infections. This research was supported by a grant from Durata Therapeutics.

The following posters will be presented:

Tuesday, September 10, 2013

12 p.m. - 2 p.m.

Title: DISCOVER 1: A Randomized, Double-blind Study of Dalbavancin (DAL) compared to Vancomycin (V) (with an option to switch to Linezolid (L)) in Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Authors: H. W. Boucher1, M. Wilcox2, G. H. Talbot3, A. Das4, S. Puttagunta5, M. Dunne5 (1Tufts Med. Ctr., Boston, MA, 2Leeds Teaching Hosp., Leeds, UNITED KINGDOM, 3Talbot Advisors, LLC, Anna Maria, FL, 4InClin, San Mateo, CA, 5Durata Therapeutics, Branford, CT)

Poster #: L-201

Tuesday, September 10, 2013

12 p.m. – 2 p.m.

Title: DISCOVER 2: A Randomized, Double-Blind Study of Dalbavancin (DAL) compared to Vancomycin (V) (with an option to switch to Linezolid (L)) in Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Authors: M. Wilcox1, H. W. Boucher2, G. H. Talbot3, A. F. Das4, S. Puttagunta5, M. Dunne5 (1Leeds Teaching Hosp., Leeds, UNITED KINGDOM, 2Tufts Med. Ctr., Boston, MA, 3Talbot Advisors, LLC, Anna Maria, FL, 4InClin, San Mateo, CA, 5Durata Therapeutics, Branford, CT)

Poster #: L-202

Tuesday, September 10, 2013

12 p.m. – 2 p.m.

Title: In Vitro Activity of Dalbavancin Against Consecutive Isolates of Staphylococcus Species Recovered from Osteomyelitis Infections

Authors: D. M. Citron, E. J. Goldstein (R.M. Alden Res. Lab., Culver City, CA)

Poster #: E-140

The abstracts are currently available on the ICAAC website at www.icaac.org and copies of the posters will be available following the ICAAC meeting at www.duratatherapeutics.com. 

About Dalbavancin

Dalbavancin is an intravenous antibiotic product candidate under investigation for once-weekly dosing, which we believe may facilitate the treatment of patients with ABSSSI in both the in-patient and out-patient settings, potentially reducing the length of a patient's hospital stay or avoiding hospital admission altogether, with an impact on the overall cost of care for these patients. 

About Durata Therapeutics, Inc.

Durata Therapeutics 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, under investigation for the treatment of patients with acute bacterial skin and skin structure infections caused by susceptible gram-positive bacteria.

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Forward-looking statements in this press release include statements about the timing of the submission of a NDA with the FDA. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the "Risk Factors" section of our most recent quarterly report on Form 10-Q, which is on file with the SEC and is also available on our website. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our views change. Therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today.

CONTACT: Investor Relations and Public Affairs Contact
         Allison Wey
         Durata Therapeutics
         Vice President, Investor Relations and Public Affairs
         (312) 219-7017
         awey@duratatherapeutics.com
         
         Media Relations Contact
         Geoff Curtis
         DJE Science
         (312) 233-1253
         geoff.curtis@djescience.com