Durata attains global rights for dalbavancin to treat abSSSI

Durata Therapeutics today announced the Company has attained worldwide rights for the development and commercialization of Durata's lead product, dalbavancin, a long-acting, intravenous (IV) lipoglycopeptide for the treatment of acute bacterial skin and skin structure infections (abSSSI). In December 2010, Durata acquired from RaQualia Pharma commercialization rights for dalbavancin in Japan. All other rights, including in North America and the European Union, were acquired from Pfizer upon the formation of Durata in late December 2009. Specific monetary terms of the acquisitions were not disclosed.

“There is a growing, worldwide need for new, broad-spectrum agents to address antibiotic resistance, as seen with methicillin-resistant Staphylococcus aureus (MRSA)”

"There is a growing, worldwide need for new, broad-spectrum agents to address antibiotic resistance, as seen with methicillin-resistant Staphylococcus aureus (MRSA)," commented Paul R. Edick, Chief Executive Officer of Durata. "Having initiated our pivotal clinical program for dalbavancin last month, we are continuing on track with the objective of submitting for regulatory approval in the United States, Europe and Asian regions. It is important for our program goals that we have attained unencumbered worldwide rights for this promising product."

Recently, Durata announced the initiation of a global, pivotal, Phase 3 study (DISCOVER-1) of dalbavancin, which is being conducted under a Special Protocol Assessment (SPA) agreed upon with the U.S. Food and Drug Administration (FDA).

Durata's Chief Medical Officer, Michael Dunne, M.D., stated, "In many regions of the world, there is public awareness and a strong and consistent approach on the part of the healthcare system to reducing the potential threat and impact of 'superbugs.' As a next-generation, late-stage therapy in the same class as vancomycin, dalbavancin offers unique attributes for use in both the hospital and community settings. These attributes include convenient, once-a-week dosing and a 30-minute infusion time. 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."

SOURCE Durata Therapeutics