Durata Therapeutics Announces Worldwide Rights for the Development and Commercialization of Advanced-Stage Antibiotic, Dalbavancin

MORRISTOWN, N.J.--(BUSINESS WIRE)--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.

“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.”

“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).

To learn more about Durata’s pivotal study for dalbavancin, please visit http://clinicaltrials.gov/ct2/show/NCT01339091?term=dalbavancin&rank=2.

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.”

About Durata Therapeutics

Durata Therapeutics is a biopharmaceutical company addressing the growing need for new therapeutics to treat infectious diseases. Durata’s current late-stage clinical product, dalbavancin, is a next-generation lipoglycopeptide with unique features, including convenient, once-a-week dosing. To date, dalbavancin has been shown to be effective and well-tolerated in late-stage clinical trials of patients with skin infections, supported by a promising safety profile based on clinical data in over 1300 patients. The Company also has two antibiotic programs in earlier-stage, preclinical research.

Durata’s senior leadership has considerable experience in running healthcare companies and broad expertise in medical affairs, operations, manufacturing and commercialization, including multiple U.S. and global product launches. Durata is supported by a premier team of venture capital organizations including New Leaf Venture Partners, LLC, Domain Associates, LLC, Aisling Capital, Sofinnova Ventures Inc. and Canaan Partners.

For more information on Durata and the Company’s programs, please visit www.duratatherapeutics.com.