Durata has taken over the Japanese commercialization rights for dalbavancin from RaQualia Pharma in December 2010.
All other rights, including in North America and the European Union, were acquired from Pfizer upon the formation of Durata in late December 2009.
Further, Durata has executed a pivotal, a randomized, double-blind, double-dummy Phase 3 (DISCOVER-1) study to investigate intravenous (IV) lipoglycopeptide dalbavancin, under a Special Protocol Assessment (SPA) agreed upon with the US Food and Drug Administration.
The company now intends to submit for the regulatory approval for dalbavancin in the US, Europe and Asian regions, following the successful completion of the trial.
Durata chief medical officer Michael Dunne said as a next-generation, late-stage therapy in the same class as vancomycin, dalbavancin offers attributes for use in both the hospital and community settings.
"Dalbavancin also has a broad spectrum of activity against important Gram-positive bacterial infections, such as MRSA, and we believe the totality of these characteristics, pending the results from our ongoing pivotal clinical program, will represent a distinctive advantage for clinicians," Dunne said.