CHICAGO, Sept. 3, 2013 (GLOBE NEWSWIRE) -- 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 The trials were conducted via a Special Protocol Assessment based on the FDA's Draft Guidance for Developing Drugs for the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI).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. Boucher 1 , M. Wilcox 2 , G. H. Talbot 3 , A. Das 4 , S. Puttagunta 5 , M. Dunne 5 ( 1 Tufts Med. Ctr., Boston, MA, 2 Leeds Teaching Hosp., Leeds, UNITED KINGDOM, 3 Talbot Advisors, LLC, Anna Maria, FL, 4 InClin, San Mateo, CA, 5 Durata 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. Wilcox 1 , H. W. Boucher 2 , G. H. Talbot 3 , A. F. Das 4 , S. Puttagunta 5 , M. Dunne 5 ( 1 Leeds Teaching Hosp., Leeds, UNITED KINGDOM, 2 Tufts Med. Ctr., Boston, MA, 3 Talbot Advisors, LLC, Anna Maria, FL, 4 InClin, San Mateo, CA, 5 Durata 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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Investor Relations and Public Affairs Contact Allison Wey Durata Therapeutics Vice President, Investor Relations and Public Affairs (312) 219-7017 Media Relations Contact Geoff Curtis DJE Science (312) 233-1253
