Branford, CT, United States
Branford, CT, United States

Durata Therapeutics, established in 2009, is a clinical development stage pharmaceutical company which focuses on the treatment of infectious diseases. The company acquired dalbavancin, a long-acting semisynthetic lipoglycopeptide antibiotic, from Pfizer in December 2009. Durata has initiated two Phase III studies of dalbavancin for intravenous treatment of acute bacterial skin and skin structure infections. In October of 2014 Durata was acquired by Actavis for about $675 million. Wikipedia.

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Research and Markets has announced the addition of the "Antibacterial Drug Resistance: Market Landscape, Challenges and Upcoming Opportunities, 2016-2026 " report to their offering. The "Antibacterial Drug Resistance: Market Landscape, Challenges and Upcoming Opportunities, 2016-2026" report provides an extensive study of the current landscape and the growing pipeline of new generation antibiotics targeting drug-resistant bacteria. As indicated earlier, owing to the over-prescription of antibiotics due to improper diagnosis, lack of adherence to proper dosage regimens, their widespread availability as over-the-counter (OTC) drugs, and overuse in agriculture and poultry farming, most antibiotics have been rendered ineffective. Moreover, there currently exists an expanding lag between the pace at which drug resistant bacteria evolve and the time taken for new drugs to reach the market. As a result, antibiotic drug resistance has escalated into a global threat. There are concerns that the lack of effective drugs in this domain may soon trigger the relapse of the pre-antibiotic era, in which individuals died due to day-to-day bacterial infections. According to certain studies, currently, an estimated 700,000 deaths annually are known to occur due to anti-microbial resistance worldwide. In future, the growing threat of antibiotic resistance is anticipated to prove to be more fatal than cancer. The current scenario depicts an urgent need for new antibiotics with novel mechanisms of action, having the ability to combat antibiotic resistance. The US and EU governments have amended their action plans and conducted many conferences to raise awareness about the situation among both experts in the domain and the general public. Such initiatives are addressed to support R&D strategies of companies engaged in the development of drugs to combat antibiotic resistance. Efforts are underway to assist drug developers in their clinical trial design issues, and even the simplification of regulatory pathways to expedite the time to market for such drugs. In addition, such initiatives endorse public-private partnerships in advancing scientific and clinical efforts in this domain, aid the setting up of surveillance programs to track the widespread use of antibiotics and the development of resistance, and track the growing economic burden due to this phenomenon as well. The new generation antibiotics pipeline comprises of several molecules that target infections caused by deadly pathogens classified under ESKAPE or as urgent threats by the CDC. Several start-ups have entered the market and undertaken various initiatives to develop novel antibiotics with unique mechanisms of action. - An overview of the current state of the market with respect to the key players involved, phase of development of pipeline products (clinical and preclinical/discovery), target classes of pathogens (Gram-negative versus Gram-positive), drug classes and key disease indications. In addition, we have included an insightful representation of the developer landscape, highlighting the geographical presence of key players in the industry. - Detailed profiles of approved drugs, as well as those in phase III of clinical development, highlighting information on clinical trials, their current status of development, recent developments and associated collaborations. - Insights on novel alternative therapies that are being explored/evaluated to target antibiotic resistant pathogenic bacteria; these include teixobactin, anti-microbial peptides, antisense antibacterials, quorum sensing inhibition, nano-metal based therapies and anti-biofilm agents. - Details on the most popular therapeutic areas, namely acute bacterial skin and skin structure infections (ABSSSIs), community-acquired pneumonia (CAP) Clostridium difficile infections (CDIs), complicated intra-abdominal infections (cIAIs), complicated urinary tract infections (cUTIs) and hospital-acquired pneumonia/ventilator-associated pneumonia (HAP/VAP). For each indication, we have provided a brief description of the disease, information on its epidemiology, available treatment plans and active comparator studies of approved drug candidates that are prescribed for the aforementioned indications. - An illustrative grid representation and a bulls-eye analysis of the pipeline molecules, based on their development stage, spectrum of activity and the key indications. - Future commercial potential of the market based on a detailed opportunity analysis, for the period between 2016 and 2026. The research, analysis and insights presented in this report include potential sales of approved antibiotics and those in late stages of development. 1. Preface 2. Executive Summary 3. Introduction 4. Antibiotic Drug Resistance: Development Pipeline and Market Landscape 5. Clinical Development Analysis and Key Comparator Studies 6. New Generation Antibiotics: Marketed Drugs 7. New Generation Antibiotics: Phase III Drugs 8. Emerging Therapies to Combat Antibiotic Resistance 9. Key Therapeutic Areas 10. Market Forecast and Opportunity Analysis 11. Conclusion 12. Interview Transcripts 13. Appendix 1: Tabulated Data 14. Appendix 2: List of Companies and Organization - AAIPharma Services - ABAC Therapeutics - ANTABIO - Abbott Laboratories - Abgentis - Absynth Biologics - Achaogen - Acino Holdings - Actavis - Actelion Pharmaceuticals - Adenium Biotech - Adimab - Aequor - AiCuris - Alaxia Pharma - Albany Molecular Research (AMRI) - Allecra Therapeutics - Allergan - Angelini - Antibio Tx - Antibiotic Adjuvant - Aphios - Appili Therapeutics - Arietis Pharma - Arpida - Arsanis - Assembly Biosciences - AstraZeneca - Austell Laboratories - Aventis Pharma - BKG Pharma - BUGWORKS - Basilea Pharmaceutica - Bayer Pharma - BioVersys - Biocidium Biopharmaceuticals - Biocon - Biosearch Italia - Biovertis - Blueberry Therapeutics - C3 Jian - Calixa Therapeutics - Cantab Anti-infectives - Cardiome Pharma - Cellceutix Corporation - Cempra - Cerexa - Clinigen Group - ContraFect - Crestone - Crystal Genomics - Cubist Pharmaceuticals - CyDex Pharmaceuticals - DSM Sinochem Pharmaceuticals - Da Volterra - Daiichi Sankyo - Debiopharm International - Deinove - Demuris - Discuva - Dong Wha Pharmaceuticals - Dong-A Pharmaceutical - Durata Therapeutics - Eli Lilly - Eligo Bioscience - EnBiotix - Entasis Therapeutics - Eurofarma Laboratórios - Evolva Holding - Evotec - Eydo Pharma - FOB Synthesis - Fedora Pharmaceuticals - Forest Laboratories - Fujisawa Pharmaceuticals - GSK - Galapagos - GangaGen - GeneWEAVE - Hikma Pharmaceuticals - IASO Pharma - iNtRON Biotechnology - Immuron - Indel Therapeutics - Institute of Metagenomics and Microbial Technologies (IMMT) - InterMune - Ionis Pharmaceuticals - Isis Pharmaceuticals - Janssen-Ortho - Japan Radio Company - Johnson & Johnson - Kyorin Pharmaceutical - LegoChem Biosciences - Ligand Pharmaceuticals - Lyndra - MGB Biopharma - Macrolide Pharmaceuticals - MarBiLeads - Matinas BioPharma - MedImmune - Meiji Seika Pharma - Melinta Therapeutics - MerLion Pharmaceuticals - Merck - MethylGene - Microbecide - MicuRx Pharmaceuticals - Mirati Therapeutics - Monash University - MorphoSys - Morphochem - Motif Bio - Mutabilis - Nabriva Therapeutics - Naicon - NanoSafe Coatings - Nanotherapeutics - Navigen Pharmaceuticals - Nemesis Bioscience - Nexgen Biosciences - Nobelex Biotech - Northeastern University - Northern Antibiotics - Nosopharm - NovaBiotics - NovaDigm Therapeutics - Novexel - NovoBiotic Pharmaceuticals - Nuprim - OJ-Bio - Optimer Biotechnology - Optimer Pharmaceuticals - Osel - PENDOPHARM - Pacific Beach BioSciences - Par Pharmaceutical - Paratek Pharmaceuticals - Patheon - Peninsula Pharmaceuticals - Peptilogics - Pfizer - Pherecydes Pharma - Phico Therapeutics - Polyphor - Procarta Biosystems - Pure Actives - R-Pharm - RQx Pharmaceuticals - RaQualia Pharma - Rebiotix - Redx Pharma - Rempex Pharmaceuticals - RexC Pharmaceuticals - Rib-X Pharmaceuticals - Roche - Rx3 Pharmaceuticals - Sanofi-Aventis - SciClone Pharmaceuticals - Sequella - Seres Therapeutics - SetLance - Shionogi - Shire - SinSa Labs - Specialised Therapeutics Australia - Spero Therapeutics - Sumitomo Dainippon Pharma (DSP) - Summit Therapeutics - Synamp Pharmaceuticals - Synthetic Biologics - TAXIS Pharmaceuticals - TaiGen Biotechnology - Takeda Pharmaceutical - Talon Pharmaceuticals - Targanta Therapeutics - TechnoPhage - Techulon - Tetraphase Pharmaceuticals - The Medicines Company - TheraBor Pharmaceuticals - Theravance Biopharma - Treat Systems - Trius Therapeutics - University of Michigan Life Sciences Institute - University of Pittsburgh - Vaxdyn - VenatoRx Pharmaceuticals - Versicor Pharmaceuticals - VibioSphen - Vicuron Pharmaceuticals - ViroPharma - Vitas Pharma - Vyome Biosciences - Wakunaga Pharmaceutical - Warner Chillcott - Wockhardt - Yamanouchi Pharmaceutical - Zavante Therapeutics For more information about this report visit http://www.researchandmarkets.com/research/gqv9bz/antibacterial


Dublin, Dec. 15, 2016 (GLOBE NEWSWIRE) -- Research and Markets has announced the addition of the "Antibacterial Drug Resistance: Market Landscape, Challenges and Upcoming Opportunities, 2016-2026 " report to their offering. The "Antibacterial Drug Resistance: Market Landscape, Challenges and Upcoming Opportunities, 2016-2026" report provides an extensive study of the current landscape and the growing pipeline of new generation antibiotics targeting drug-resistant bacteria. As indicated earlier, owing to the over-prescription of antibiotics due to improper diagnosis, lack of adherence to proper dosage regimens, their widespread availability as over-the-counter (OTC) drugs, and overuse in agriculture and poultry farming, most antibiotics have been rendered ineffective. Moreover, there currently exists an expanding lag between the pace at which drug resistant bacteria evolve and the time taken for new drugs to reach the market. As a result, antibiotic drug resistance has escalated into a global threat. There are concerns that the lack of effective drugs in this domain may soon trigger the relapse of the pre-antibiotic era, in which individuals died due to day-to-day bacterial infections. According to certain studies, currently, an estimated 700,000 deaths annually are known to occur due to anti-microbial resistance worldwide. In future, the growing threat of antibiotic resistance is anticipated to prove to be more fatal than cancer. The current scenario depicts an urgent need for new antibiotics with novel mechanisms of action, having the ability to combat antibiotic resistance. The US and EU governments have amended their action plans and conducted many conferences to raise awareness about the situation among both experts in the domain and the general public. Such initiatives are addressed to support R&D strategies of companies engaged in the development of drugs to combat antibiotic resistance. Efforts are underway to assist drug developers in their clinical trial design issues, and even the simplification of regulatory pathways to expedite the time to market for such drugs. In addition, such initiatives endorse public-private partnerships in advancing scientific and clinical efforts in this domain, aid the setting up of surveillance programs to track the widespread use of antibiotics and the development of resistance, and track the growing economic burden due to this phenomenon as well. The new generation antibiotics pipeline comprises of several molecules that target infections caused by deadly pathogens classified under ESKAPE or as urgent threats by the CDC. Several start-ups have entered the market and undertaken various initiatives to develop novel antibiotics with unique mechanisms of action. The report features: - An overview of the current state of the market with respect to the key players involved, phase of development of pipeline products (clinical and preclinical/discovery), target classes of pathogens (Gram-negative versus Gram-positive), drug classes and key disease indications. In addition, we have included an insightful representation of the developer landscape, highlighting the geographical presence of key players in the industry. - Detailed profiles of approved drugs, as well as those in phase III of clinical development, highlighting information on clinical trials, their current status of development, recent developments and associated collaborations. - Insights on novel alternative therapies that are being explored/evaluated to target antibiotic resistant pathogenic bacteria; these include teixobactin, anti-microbial peptides, antisense antibacterials, quorum sensing inhibition, nano-metal based therapies and anti-biofilm agents. - Details on the most popular therapeutic areas, namely acute bacterial skin and skin structure infections (ABSSSIs), community-acquired pneumonia (CAP) Clostridium difficile infections (CDIs), complicated intra-abdominal infections (cIAIs), complicated urinary tract infections (cUTIs) and hospital-acquired pneumonia/ventilator-associated pneumonia (HAP/VAP). For each indication, we have provided a brief description of the disease, information on its epidemiology, available treatment plans and active comparator studies of approved drug candidates that are prescribed for the aforementioned indications. - An illustrative grid representation and a bulls-eye analysis of the pipeline molecules, based on their development stage, spectrum of activity and the key indications. - Future commercial potential of the market based on a detailed opportunity analysis, for the period between 2016 and 2026. The research, analysis and insights presented in this report include potential sales of approved antibiotics and those in late stages of development. Key Topics Covered: 1. Preface 2. Executive Summary 3. Introduction 4. Antibiotic Drug Resistance: Development Pipeline and Market Landscape 5. Clinical Development Analysis and Key Comparator Studies 6. New Generation Antibiotics: Marketed Drugs 7. New Generation Antibiotics: Phase III Drugs 8. Emerging Therapies to Combat Antibiotic Resistance 9. Key Therapeutic Areas 10. Market Forecast and Opportunity Analysis 11. Conclusion 12. Interview Transcripts 13. Appendix 1: Tabulated Data 14. Appendix 2: List of Companies and Organization - AAIPharma Services - ABAC Therapeutics - ANTABIO - Abbott Laboratories - Abgentis - Absynth Biologics - Achaogen - Acino Holdings - Actavis - Actelion Pharmaceuticals - Adenium Biotech - Adimab - Aequor - AiCuris - Alaxia Pharma - Albany Molecular Research (AMRI) - Allecra Therapeutics - Allergan - Angelini - Antibio Tx - Antibiotic Adjuvant - Aphios - Appili Therapeutics - Arietis Pharma - Arpida - Arsanis - Assembly Biosciences - AstraZeneca - Austell Laboratories - Aventis Pharma - BKG Pharma - BUGWORKS - Basilea Pharmaceutica - Bayer Pharma - BioVersys - Biocidium Biopharmaceuticals - Biocon - Biosearch Italia - Biovertis - Blueberry Therapeutics - C3 Jian - Calixa Therapeutics - Cantab Anti-infectives - Cardiome Pharma - Cellceutix Corporation - Cempra - Cerexa - Clinigen Group - ContraFect - Crestone - Crystal Genomics - Cubist Pharmaceuticals - CyDex Pharmaceuticals - DSM Sinochem Pharmaceuticals - Da Volterra - Daiichi Sankyo - Debiopharm International - Deinove - Demuris - Discuva - Dong Wha Pharmaceuticals - Dong-A Pharmaceutical - Durata Therapeutics - Eli Lilly - Eligo Bioscience - EnBiotix - Entasis Therapeutics - Eurofarma Laboratórios - Evolva Holding - Evotec - Eydo Pharma - FOB Synthesis - Fedora Pharmaceuticals - Forest Laboratories - Fujisawa Pharmaceuticals - GSK - Galapagos - GangaGen - GeneWEAVE - Hikma Pharmaceuticals - IASO Pharma - iNtRON Biotechnology - Immuron - Indel Therapeutics - Institute of Metagenomics and Microbial Technologies (IMMT) - InterMune - Ionis Pharmaceuticals - Isis Pharmaceuticals - Janssen-Ortho - Japan Radio Company - Johnson & Johnson - Kyorin Pharmaceutical - LegoChem Biosciences - Ligand Pharmaceuticals - Lyndra - MGB Biopharma - Macrolide Pharmaceuticals - MarBiLeads - Matinas BioPharma - MedImmune - Meiji Seika Pharma - Melinta Therapeutics - MerLion Pharmaceuticals - Merck - MethylGene - Microbecide - MicuRx Pharmaceuticals - Mirati Therapeutics - Monash University - MorphoSys - Morphochem - Motif Bio - Mutabilis - Nabriva Therapeutics - Naicon - NanoSafe Coatings - Nanotherapeutics - Navigen Pharmaceuticals - Nemesis Bioscience - Nexgen Biosciences - Nobelex Biotech - Northeastern University - Northern Antibiotics - Nosopharm - NovaBiotics - NovaDigm Therapeutics - Novexel - NovoBiotic Pharmaceuticals - Nuprim - OJ-Bio - Optimer Biotechnology - Optimer Pharmaceuticals - Osel - PENDOPHARM - Pacific Beach BioSciences - Par Pharmaceutical - Paratek Pharmaceuticals - Patheon - Peninsula Pharmaceuticals - Peptilogics - Pfizer - Pherecydes Pharma - Phico Therapeutics - Polyphor - Procarta Biosystems - Pure Actives - R-Pharm - RQx Pharmaceuticals - RaQualia Pharma - Rebiotix - Redx Pharma - Rempex Pharmaceuticals - RexC Pharmaceuticals - Rib-X Pharmaceuticals - Roche - Rx3 Pharmaceuticals - Sanofi-Aventis - SciClone Pharmaceuticals - Sequella - Seres Therapeutics - SetLance - Shionogi - Shire - SinSa Labs - Specialised Therapeutics Australia - Spero Therapeutics - Sumitomo Dainippon Pharma (DSP) - Summit Therapeutics - Synamp Pharmaceuticals - Synthetic Biologics - TAXIS Pharmaceuticals - TaiGen Biotechnology - Takeda Pharmaceutical - Talon Pharmaceuticals - Targanta Therapeutics - TechnoPhage - Techulon - Tetraphase Pharmaceuticals - The Medicines Company - TheraBor Pharmaceuticals - Theravance Biopharma - Treat Systems - Trius Therapeutics - University of Michigan Life Sciences Institute - University of Pittsburgh - Vaxdyn - VenatoRx Pharmaceuticals - Versicor Pharmaceuticals - VibioSphen - Vicuron Pharmaceuticals - ViroPharma - Vitas Pharma - Vyome Biosciences - Wakunaga Pharmaceutical - Warner Chillcott - Wockhardt - Yamanouchi Pharmaceutical - Zavante Therapeutics For more information about this report visit http://www.researchandmarkets.com/research/gtt9s3/antibacterial


Dunne M.W.,Durata Therapeutics | Puttagunta S.,Durata Therapeutics | Sprenger C.R.,PRACS Institute Ltd. | Rubino C.,Institute for Clinical Pharmacodynamics | And 2 more authors.
Antimicrobial Agents and Chemotherapy | Year: 2015

Dalbavancin is an intravenous lipoglycopeptide with activity against Gram-positive pathogens and an MIC90 for Staphylococcus aureus of 0.06 μg/ml. With a terminal half-life of>14 days, dosing regimens with infrequent parenteral administration become available to treat infectious diseases such as osteomyelitis and endocarditis that otherwise require daily dosing for many weeks. In order to support a rationale for these novel regimens, the pharmacokinetics over an extended dosing interval and the distribution of dalbavancin into bone and articular tissue were studied in two phase I trials and pharmacokinetic modeling was performed. Intravenous administration of 1,000 mg of dalbavancin on day 1 followed by 500 mg weekly for seven additional weeks was well tolerated and did not demonstrate evidence of drug accumulation. In a separate study, dalbavancin concentrations in cortical bone 12 h after infusion of a single 1,000-mg intravenous infusion were 6.3 μg/g and 2 weeks later were 4.1 μg/g. A twodose, once-weekly regimen that would provide tissue exposure over the dalbavancin MIC for Staphylococcus aureus for 8 weeks, maximizing the initial exposure to treatment while minimizing the frequency of intravenous therapy, is proposed. Copyright © 2015, American Society for Microbiology. All Rights Reserved.


Boucher H.W.,Tufts University | Wilcox M.,University of Leeds | Talbot G.H.,Talbot Advisors | Puttagunta S.,Durata Therapeutics | And 2 more authors.
New England Journal of Medicine | Year: 2014

BACKGROUND: Dalbavancin, a lipoglycopeptide antibiotic agent that is active against gram-positive pathogens, has a long plasma half-life, allowing for once-weekly dosing. DISCOVER 1 and DISCOVER 2 were identically designed noninferiority trials of dalbavancin for the treatment of acute bacterial skin and skin-structure infection. METHODS: We randomly assigned patients to receive dalbavancin intravenously on days 1 and 8 or vancomycin intravenously for at least 3 days with the option to switch to oral linezolid to complete 10 to 14 days of therapy. The primary end point, early clinical response, required the cessation of spread of infection-related erythema and the absence of fever at 48 to 72 hours. Secondary end points at the end of therapy included clinical status and investigator's assessment of outcome. RESULTS: Analysis of the primary end point showed noninferiority of dalbavancin in both DISCOVER 1 and DISCOVER 2. In the pooled analysis, 525 of 659 patients (79.7%) in the dalbavancin group and 521 of 653 (79.8%) in the vancomycin-linezolid group had an early clinical response indicating treatment success (weighted difference, -0.1 percentage point; 95% confidence interval, -4.5 to 4.2). The outcomes were similar in the analyses by study and the pooled analyses of clinical status at the end of therapy and the investigator's assessment of outcome. For patients infected with Staphylococcus aureus, including methicillin-resistant S. aureus, clinical success was seen in 90.6% of the patients treated with dalbavancin and 93.8% of those treated with vancomycin-linezolid. Adverse events and study days with an adverse event were less frequent in the dalbavancin group than in the vancomycin-linezolid group. The most common treatment-related adverse events in either group were nausea, diarrhea, and pruritus. CONCLUSIONS: Once-weekly intravenous dalbavancin was not inferior to twice-daily intravenous vancomycin followed by oral linezolid for the treatment of acute bacterial skin and skin-structure infection. Copyright © 2014 Massachusetts Medical Society.


Dunne M.W.,Durata Therapeutics | Zhou M.,iCardiac Technologies | Darpo B.,iCardiac Technologies | Darpo B.,Karolinska Institutet
International Journal of Antimicrobial Agents | Year: 2015

Two hundred healthy subjects were enrolled in a randomised, partially double-blinded, single-centre, parallel design thorough QT study to demonstrate that dalbavancin had no clinical effect on the 12-lead ECG QTc. Fifty patients in each group received either dalbavancin 1000 mg intravenous (i.v.), dalbavancin 1500 mg i.v. or placebo i.v., each infused over 30 min, or 400 mg oral moxifloxacin. Ten replicate 12-lead ECGs were extracted at pre-defined time points before and up to 24 h post dosing and at corresponding time points during baseline. Dalbavancin did not have an effect on the QTcF interval, and an effect exceeding 10 ms could be excluded at all time points after a single i.v. dose of 1000 mg and 1500 mg. The largest placebo-corrected change-from-baseline QTcF (ΔΔQTcF) was 1.5 ms in the 1000 mg dalbavancin group at 6 h and 0.2 ms in the 1500 mg group at 24 h. A small concentration-dependent effect of dalbavancin on ΔΔQTcF was identified with an estimated negative population slope of -0.0051 ms per μg/mL. Assay sensitivity was demonstrated by the effect of 400 mg moxifloxacin, which peaked at 2 h at ΔΔQTcF of 12.9 ms, with the lower bound of the 90% CI of the effect exceeding 5 ms at all three pre-defined time points. Dalbavancin did not exert a relevant effect on heart rate or PR or QRS intervals. Dalbavancin in i.v. doses up to 1500 mg did not prolong the QTc interval and had no effect on heart rate or PR and QRS intervals. © 2015 The Authors. Published by Elsevier B.V. on behalf of International Society of Chemotherapy.

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