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Press Releases
DURATA THERAPEUTICS INITIATES ENROLLMENT IN DISCOVER-2, SECOND PHASE 3 STUDY OF DALBAVANCIN FOR THE TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS
MORRISTOWN, N.J. -- (BUSINESS WIRE) -- September 29, 2011 -- Durata Therapeutics today announced the Company has initiated enrollment in a second global, pivotal, Phase 3 study (DISCOVER-2) of its lead product, dalbavancin, a long-acting, intravenous (IV) lipoglycopeptide for the treatment of acute bacterial skin and skin structure infections (abSSSI). Read Full Press Release
DURATA THERAPEUTICS ANNOUNCES DALBAVANCIN PRODUCTION CAPABILITIES AND SIGNING OF GLOBAL MANUFACTURING AGREEMENT
MORRISTOWN, N.J. --(BUSINESS WIRE)-- June 06, 2011 -- Durata Therapeutics today announced the successful production of clinical supplies of dalbavancin, the Company’s lead product, at two top-tier manufacturing facilities. Durata also announced the signing of a global, multi-year agreement with one of these manufacturers. Dalbavancin is a long-acting, intravenous (IV) lipoglycopeptide for the treatment of acute bacterial skin and skin structure infections (abSSSI). Additional details of the agreements were not disclosed. Read Full Press Release
DURATA ANNOUNCES ANTIBIOTIC SURVEILLANCE RESULTS FOR DALBAVANCIN PRESENTED AT ECCMID MEETING
MORRISTOWN, N.J. -- May 10, 2011 -- Durata Therapeutics today announced surveillance data demonstrating potency of the Company’s lead antibiotic product, dalbavancin, a long-acting, intravenous (IV) lipoglycopeptide, against a broad spectrum of gram-positive bacteria prevalent in recent years. The surveillance data also confirmed that the susceptibility profile of dalbavancin has not changed since surveillance studies were first initiated over a decade ago. Read Full Press Release
DURATA ANNOUNCES SUPPORTIVE DATA ANALYSIS FROM PHASE 3 DALBAVANCIN TRIAL AT ECCMID MEETING
MORRISTOWN, N.J. -- (BUSINESS WIRE) -- May 09, 2011 -- Durata Therapeutics today announced supportive, retrospective data from a previously completed global, Phase 3 study of the Company’s lead product, dalbavancin, a long-acting, intravenous (IV) lipoglycopeptide. As reported in a poster presentation titled, “Dalbavancin vs Linezolid for Treatment of Acute Bacterial Infections of the Skin: A Comparison of Early and Standard Outcome Measures in Study VER001-9”, a reanalysis of data from that Phase 3 study demonstrated that clinical efficacy associated with dalbavancin was again similar to linezolid, in these analyses based on both resolution of fever and cessation of spread of the lesion within a 48- to 96-hour period after the start of therapy. Recently, the Food and Drug Administration (FDA) issued new draft guidance establishing that antibiotic effectiveness be assessed between 48 and 72 hours following initiation of therapy. Read Full Press Release
DURATA THERAPEUTICS RECEIVES POSITIVE SCIENTIFIC ADVICE FROM EUROPEAN MEDICINES AGENCY (EMA)
MORRISTOWN, N.J. -- May 04, 2011 -- Durata Therapeutics today announced the Company has received positive Scientific Advice from the European Medicines Agency (EMA) on the pivotal clinical development plan for dalbavancin, Durata’s long-acting, intravenous (IV) lipoglycopeptide for the treatment of acute bacterial skin and skin structure infections (abSSSI). The EMA’s Advice is in concert with the output of a Special Protocol Assessment (SPA) agreed upon with the U.S. Food and Drug Administration (FDA). Based on this comprehensive body of regulatory guidance, Durata is conducting a global, pivotal, Phase 3 study (DISCOVER-1) of dalbavancin, initiated in March of this year. Read Full Press Release
DURATA THERAPEUTICS ANNOUNCES WORLDWIDE RIGHTS FOR THE DEVELOPMENT AND COMMERCIALIZATION OF ADVANCED-STAGE ANTIBIOTIC, DALBAVANCIN
MORRISTOWN, N.J. -- (BUSINESS WIRE) -- April 26, 2011 -- 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. Read Full Press Release
FDA HAS PROVIDED SPECIAL PROTOCOL ASSESSMENT AGREEMENT FOR PIVOTAL CLINICAL STUDY
MORRISTOWN, N.J. -- (BUSINESS WIRE) -- April 18, 2011 -- Durata Therapeutics today announced the Company initiated a global, pivotal, Phase 3 study (DISCOVER-1) of its lead product, dalbavancin, a long-acting, intravenous (IV) lipoglycopeptide for the treatment of acute bacterial skin and skin structure infections (abSSSI). The pivotal study is being conducted under a Special Protocol Assessment (SPA) agreed upon with the U.S. Food and Drug Administration (FDA). Read Full Press Release
RAQUALIA ANNOUNCES AGREEMENT WITH DURATA THERAPEUTICS FOR JAPANESE RIGHTS TO DALBAVANCIN
Dec 21, 2010 -- RaQualia Pharma Inc (RaQualia), a biopharmaceutical company based in Aichi, Japan announced today that it has entered into an agreement with Durata Therapeutics (Durata), a specialist biopharmaceutical company based in Morristown, New Jersey. Under the terms of the agreement, Durata obtained RaQualia's Japanese rights to develop and commercialize of dalbavancin. Read Full Press Release
DURATA THERAPEUTICS ANNOUNCES SENIOR LEADERSHIP TEAM
MORRISTOWN, N.J. -- (BUSINESS WIRE) -- Oct 15, 2010 -- Durata Therapeutics today announced the formation of the Company’s senior leadership team with the appointments of Paul R. Edick as Chief Executive Officer, Corey N. Fishman as Chief Operating Officer and Michael Dunne, MD, as Chief Medical Officer. The senior team has substantial healthcare industry experience, including at leading companies, such as Johnson & Johnson, G.D. Searle and Pharmacia (Mr. Edick), Monsanto, Searle and Pharmacia (Mr. Fishman) and Pfizer (Dr. Dunne). The appointment of Mr. Edick was effective July 1st, Mr. Fishman August 15th and Dr. Dunne September 1st. Read Full Press Release
NEWLY FORMED DURATA THERAPEUTICS ACQUIRES PFIZER’S VICURON SUBSIDIARY
NEW YORK -- (BUSINESS WIRE) -- Dec 21, 2009 -- Durata Therapeutics, Inc. announced today that it has acquired Vicuron Pharmaceuticals from Pfizer (PFE). Durata is a newly formed biopharmaceutical company that was created by a five-member venture capital syndicate to pursue late-stage clinical development of novel antibiotic programs. The acquisition was funded through a stock purchase by New Leaf Venture Partners, LLC, Domain Associates, LLC, Aisling Capital, Sofinnova Ventures Inc. and Canaan Partners. Durata is focused primarily on Vicuron’s antibiotic drug candidate, dalbavancin. Durata’s product portfolio also includes two preclinical antibiotic programs. Pfizer will retain the marketed anti-fungal agent, Eraxis™ (anidulafungin), which was formerly owned by Vicuron. Read Full Press Release