Durata Therapeutics Announces Completion of QT Study of Dalbavancin
SAN FRANCISCO--(BUSINESS WIRE)--Sep 11, 2012 - Durata Therapeutics (NASDAQ: DRTX) today announced results from its QT study of the company's lead product candidate, dalbavancin. Dalbavancin is currently under investigation in two ongoing, global, Phase 3 clinical trials for the treatment of acute bacterial skin and skin structure infections (ABSSSI). The QT study data, presented at the 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), showed that in this study dalbavancin had no clinically significant impact on cardiac conduction.
The U.S. Food and Drug Administration (FDA) generally requires thorough QT studies for new chemical entities due to the risk of heart arrhythmias associated with some pharmaceutical products. The results observed in Durata's definitive study are intended to satisfy the FDA's requirements in this area. These data will be included in the company's New Drug Application (NDA) for dalbavancin, which Durata anticipates submitting with the FDA in the first half of 2013.
For more information on this and four other Durata-related studies presented at ICAAC 2012, visit www.duratatherapeutics.com/media-center/publications.
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.
Durata Therapeutics is a pharmaceutical company focused on the development and commercialization of novel therapeutics for patients with infectious diseases and acute illnesses. Durata is currently enrolling and dosing patients in two global Phase 3 clinical trials with its lead product candidate, dalbavancin, for the treatment of patients with acute bacterial skin and skin structure infections, or ABSSSI.
Statements contained in this press release contain forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include statements about the content and timing of the filing of a New Drug Application with the U.S. Food and Drug Administration. 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: Media Relations Contact
White Oak Communications, Inc.
Investor Relations Contacts
Chief Operating Officer and Chief Financial Officer
Lee M. Stern
The Trout Group LLC
Posted: September 2012