Dalbavancin surveillance antibiotic results for Gram-positive pathogens presented at ECCMID meeting

Durata Therapeutics today announced surveillance data demonstrating potency of the Company's lead antibiotic product, dalbavancin, a long-acting, intravenous (IV) lipoglycopeptide, against a broad spectrum of gram-positive bacteria prevalent in recent years. The surveillance data also confirmed that the susceptibility profile of dalbavancin has not changed since surveillance studies were first initiated over a decade ago.

The findings were presented in two posters titled, "Dalbavancin Surveillance Results for European Gram-positive Species in a Contemporary (2006-2009) Sample of 23,825 Strains" and "Dalbavancin Activity and Spectrum Evaluated Against a Contemporary (2007-2009) Worldwide Collection of Staphylococci (62,590 strains)," based on results from Dr. Ron Jones and his coauthors at the Jones Microbiology Institute (JMI) Laboratories in North Liberty, Iowa.

In the first poster presentation, dalbavancin was shown to exhibit potent activity against an updated surveillance collection of Gram-positive pathogens isolated in the EU spanning from 2006 to 2009. These results have remained stable in surveillance programs over seven years (2003 to 2009) of monitoring.

In the second poster presentation, dalbavancin demonstrated sustained, potent inhibition against contemporary staphylococci strains worldwide (2007 to 2009), including methicillin-resistant Staphylococcus aureus (MRSA). Dalbavancin's activity was found to be many-fold greater than currently available glycopeptides- or lipopeptide-class agents.

Dr. Jones, President and Chief Executive Officer of JMI Laboratories, commented, "From our resistance surveillance program results presented at the ECCMID meeting (Milan) for 62,590 staphylococci sampled worldwide, we can predict that this drug will inhibit all MRSA at less than or equal to 0.5 milligrams per liter. This level of activity was consistent over time (2006 to 2009), across geographic regions (USA and Europe), and was four- to 16-fold more potent than vancomycin, daptomycin and linezolid."

Dr. Jones continued, "The convenient, once-daily dalbavancin dosing regimen for projected acute bacterial skin and skin structure infection trials in future clinical practice will be a welcome addition to MRSA therapies in various clinical settings, including hospitals, emergency rooms and out-patient intravenous treatment programs."

Durata's Chief Medical Officer, Michael Dunne, M.D., stated, "Dalbavanin has shown a remarkable degree of consistency in terms of its potency and resistance profiles since the first surveillance studies began a decade ago. Given its performance over the course of this long period of exposure, we believe dalbavancin is well positioned to successfully treat prevalent infectious pathogens in the coming years. We are pleased with the surveillance results and look forward to the progress of our late-stage clinical development program for dalbavancin."

In April 2011, Durata commenced a global, pivotal, Phase 3 study (DISCOVER-1) of dalbavancin under a Special Protocol Assessment (SPA) agreed upon with the FDA. The study is designed to compare the efficacy and safety of dalbavancin to vancomycin and is expected to enroll approximately 556 patients worldwide. Patients will be randomized to receive either two doses of dalbavancin, each infused over 30 minutes, one week apart from each other, or 10 to 14 days of the comparator regimen. Clinical response will be measured at 48 to 72 hours post study initiation and again at study day 14-15.