Durata Confirms FDA Approval of DALVANCE for Skin Infections

Durata Therapeutics, Inc.

announced today that the U.S. Food and Drug Administration (FDA) has approved DALVANCE^TM (dalbavancin) for injection for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). DALVANCE is the first and only IV antibiotic approved for the treatment of ABSSSI with a two-dose regimen of 1000 mg followed one week later by 500 mg, each administered over 30 minutes. "We are proud to bring DALVANCE to market for the millions of Americans who may benefit from an innovative treatment option for ABSSSI in today's evolving health care environment," said Paul Edick, Chief Executive Officer of Durata Therapeutics. "DALVANCE's unique dosage regimen offers a new approach to treatment of these serious skin infections by allowing patients, health care professionals and hospitals to move beyond the standard daily or twice-daily IV antibiotic infusions." Mr. Edick continued, "We are executing on all fronts to complete the necessary activities required to launch and ensure success. The time to build out and train a first-class salesforce, complete packaging and final qualification activities keeps us on track to begin shipping in the third quarter." For the six-month period of January to June 2010, a projected 9.2 million patients were treated in U.S. hospitals for infections of any type, and nearly 17 percent of the diagnostic category presentations were for skin and skin structure infections (SSSI). Of these presentations for SSSI, approximately 74 percent were disease types included in ABSSSI. This category of infection increased by 176 percent from 1997 to 2009 in hospitalized patients. The majority of skin and soft tissue infections in hospitalized patients are caused by Staphylococcus aureus, and approximately 59 percent of these infections are estimated to be caused by MRSA in the U.S. Effective early treatment of ABSSSI is critical to prevent wound expansion and to avoid lengthy and costly hospital stays. Failure to successfully treat ABSSSI may result in hospital readmissions. "Health care providers and hospitals are under enormous pressure to contain costs while still delivering high-quality care that does not compromise patient outcomes," said David Talan, MD, FACEP, FIDSA, Chairman, Department of Emergency Medicine and Faculty, Division of Infectious Diseases, Olive View-UCLA Medical Center. "The approval of DALVANCE is significant in this regard because it allows physicians to provide continuity of care across treatment settings for patients with ABSSSI as it helps reduce, or in some cases, may eliminate, the time patients spend in hospitals by providing an opportunity for care in an ambulatory setting. These outpatient settings may offer a more convenient and potentially less costly treatment experience while still delivering high-quality care and proper follow up." The entire DALVANCE clinical program encompassed 21 clinical trials with five Phase 3 trials evaluating nearly 3,000 patients. Two Phase 3 trials, DISCOVER 1 and DISCOVER 2 ("Dalbavancin for Infections of the Skin COmpared to Vancomycin at an Early Response"), were conducted under a Special Protocol Assessment (SPA) with the FDA and included more than 1,300 patients with ABSSSI. The clinical trials showed DALVANCE was non-inferior to the comparator regimen and met its primary and secondary endpoints of early response, measured at 48 to 72 hours of therapy, and clinical success at the end of treatment in patients with very large skin lesions and high frequencies of fever. DALVANCE was granted priority review as a Qualified Infectious Disease Product (QIDP), in accordance with the Generating Antibiotics Incentives Now (GAIN) Act, which was passed by Congress in 2012 to help make antibiotic development processes smoother. "A 2013 report from the CDC warned that antimicrobial resistance is one of the most serious health concerns in the U.S., and the FDA recognized the need for new antibiotics by granting DALVANCE priority review with QIDP status," said Michael Dunne, MD, Chief Medical Officer of Durata Therapeutics. "DALVANCE is the first antibiotic approved for ABSSSI under the GAIN Act. It performed very well in clinical trials relative to the current standard, vancomycin, in studies designed to be consistent with guidance provided by the FDA for antibiotic development with efficacy defined by an early response in 48 to 72 hours, as well as clinical success at the end of treatment."