Actavis and Durata Therapeutics, Inc., have entered into a definitive merger agreement under which a subsidiary of Actavis will purchase Durata for approximately $675 million. The acquisition of Durata immediately enhances Actavis’ infectious disease portfolio with the addition of Dalvance (dalbavancin) for injection, the first and only IV antibiotic for acute bacterial skin and skin structure infections (ABSSSI) with once-a-week dosing for two weeks. Dalvance was approved by the U.S. Food and Drug Administration (FDA) on May 23, 2014 and was the first drug approved as a Qualified Infectious Disease Product (QIDP). A Marketing Authorization Application (MAA) for dalbavancin is under review with the European Medicines Agency, with a decision anticipated in the first half of 2015. A single-dose regimen of Dalvance is also in late-stage development for ABSSSI, with a supplemental New Drug Application (sNDA) filing expected by mid-2015. Durata also has plans to continue the development of Dalvance for additional indications, such as hospitalized community-acquired pneumonia and pediatric osteomyelitis.    

“The acquisition of Durata is a strong strategic fit that strengthens Actavis’ emerging infectious disease franchise and aligns with our stated goal to make smart, targeted investments that complement our existing businesses and position the company for continued long-term growth,” said Brent Saunders, chief executive officer and president of Actavis.

“Actavis recognizes Dalvance as a strong development asset with significant potential. By joining Actavis, we gain additional resources, commercial reach and scale to expand patient access and realize the full potential of Dalvance in the marketplace,” said Paul R. Edick, Durata’s chief executive officer.