Durata Says Skin Infection Drug Meets Late-Stage Trial Goal

December 11, 2012

(Reuters) - Durata Therapeutics Inc said its experimental skin antibiotic dalbavancin met the goal of a late-stage trial, and it expects to seek marketing approval for the intravenous drug next year.

The company is testing two doses of the antibiotic as a treatment for acute bacterial skin and skin structure infections due to gram-positive bacteria, including methicillin-resistant staphylococcus aureus (MRSA).

In the DISCOVER 1 trial, the once-weekly dalbavancin was tested against twice-daily doses of vancomycin, the standard first-line treatment for MRSA infections, for 14 days.

Preliminary data showed that the drug met the primary goal of stopping the spread of the skin lesion, as well as treating fever 48 to 72 hours after initiation of therapy, the company said.

The company said it expects to file with U.S. health regulators for marketing approval of the drug in the first half of 2013.