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Product Profiles: Pipeline Antibacterials - Gram-Negative Combination Antibiotics Show Promise in MRSA-Focused Pipeline
Date:3/19/2012

NEW YORK, March 19, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Product Profiles: Pipeline Antibacterials – Gram-negative combination antibiotics show promise in MRSA-focused pipeline http://www.reportlinker.com/p0799266/Product-Profiles-Pipeline-Antibacterials-–-Gram-negative-combination-antibiotics-show-promise-in-MRSA-focused-pipeline.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Drug_and_Medication

The majority of the drugs in the late stage of the pipeline are being developed to target Gram-positive infections, including methicillin-resistant Staphylococcus aureus (MRSA). Progress has been slow, with many drugs held up by the US FDA's changing guidance on the design of antibiotic clinical trials. If successful, agents will be entering a large, but increasingly crowded, anti-MRSA market.Extensive analysis of clinical trial data and assessment of clinical and commercial attractiveness for pipeline antibacterialsDiscussion of future strategic opportunities to achieve success in an increasingly crowded antibacterials marketAnalysis of the ability of pipeline drugs to satisfy key unmet needs in the antibacterials space

Two promising antibacterials were launched in the US in 2011. Teflaro is the first cephalosporin to target MRSA, but enters an increasingly crowded market. Dificid is only the second drug in the US to be approved for Clostridium difficile-associated diarrhea, demonstrating reduced rates of relapse, however high pricing may prevent rapid uptake.

Several antibiotics are in late stage development that target MRSA, from oral once daily drugs, to antibiotics that require only one or two doses per treatment course. Their convenience and potential to save significant hospital resources makes them very attractive therapies, but each will compete to reach the market first.

Two highly anticipated combination therapies targeting serious Gram-negative infections, including multidrug-resistant pathogens, entered Phase III in 2011. If approved, they will be direct competitors as both cover many of the same organisms, but one has the ability to meet specific key unmet needs better than the other.

Identify key drugs within the antibacterials pipeline, success factors for recently launched brands, and the potential for new entrant products.Assess strengths, weaknesses, opportunities and threats of key pipeline antibacterials and how they influence clinical and commercial attractiveness.Understand the impact of events such as changing FDA guidances on clinical trial design, and successful and unsuccessful partnership deals.

OVERVIEWCatalystSummaryEXECUTIVE SUMMARYStrategic scoping and focusDatamonitor key findingsRelated reportsPRODUCT OVERVIEWKey pipeline products for antibacterialsPIPELINE PRODUCT PROFILESTeflaro/Zinforo (ceftaroline fosamil; Forest Laboratories/AstraZeneca)Drug profileDevelopment overview SWOT analysisSatisfaction of unmet needsClinical and commercial attractivenessDificid/Dificlir (fidaxomicin; Optimer Pharmaceuticals/Astellas Pharma)Drug profileDevelopment overview SWOT analysisSatisfaction of unmet needsClinical and commercial attractivenessTedizolid phosphate (Trius Therapeutics/Dong-A Pharmaceutical/Bayer)Drug profileDevelopment overview Ongoing clinical trialsSWOT analysisSatisfaction of unmet needsClinical and commercial attractivenessPTK 0796 (Paratek Pharmaceuticals)Drug profileDevelopment overviewOngoing clinical trialsSWOT analysisSatisfaction of unmet needsClinical and commercial attractivenessDalbavancin (Durata Therapeutics)Drug profileDevelopment overview Ongoing clinical trialsSWOT analysisSatisfaction of unmet needsClinical and commercial attractivenessOritavancin (The Medicines Company)Drug profileDevelopment overview Ongoing clinical trialsSWOT analysisSatisfaction of unmet needsClinical and commercial attractivenessCXA-201 (CXA-101/tazobactam; Cubist Pharmaceuticals)Drug profileDevelopment overview Ongoing clinical trialsSWOT analysisSatisfaction of unmet needsClinical and commercial attractivenessCAZ-AVI (ceftazidime/avibactam; Forest Laboratories/AstraZeneca)Drug profileDevelopment overviewSWOT analysisSatisfaction of unmet needsClinical and commercial attractivenessOther pipeline antibacterialsCB-183,315 (Cubist Pharmaceuticals)Delafloxacin (Rib-X)BC-3781 (Nabriva Therapeutics)TP-434 (Tetraphase Pharmaceuticals)Ceftaroline/avibactam (ceftaroline/avibactam; Forest Laboratories/AstraZeneca)PMX-30063 (PolyMedix)GSK-052 (Anacor Pharmaceuticals/GlaxoSmithKline)Ceftobiprole (Basilea Pharmaceutica)Cethromycin (Advanced Life Sciences)BIBLIOGRAPHYJournal papersWebsitesDatamonitor reportsAPPENDIXPharmaVitae Explorer databaseContributing expertsConferences attendedReport methodology

TABLES

Table: Key pipeline products for antibacterials, 2011

Table: Teflaro/Zinforo (ceftaroline fosamil; Forest laboratories/AstraZeneca) – drug profile, 2011

Table: Summary of the pivotal Phase III clinical trials for Teflaro/Zinforo ( c eftaroline fosamil) in the treatment of ABSSSIs and CABP, 2011

Table: Ability of Teflaro/Zinforo (ceftaroline fosamil) to meet unmet needs, 2011

Table: Datamonitor drug assessment summary of Teflaro/Zinforo (ceftaroline fosamil; Forest Laboratories/AstraZeneca), 2011

Table: Dificid/Dificlir (fidaxomicin; Optimer Pharmaceuticals/Astellas Pharma) – drug profile, 2011

Table: Summary of the key Phase III clinical trials for Dificid/Dificlir (fidaxomicin) in the treatment of CDAD, 2011

Table: Ability of Dificid/Dificlir (fidaxomicin) to meet unmet needs, 2011

Table: Datamonitor drug assessment summary of Dificid/Dificlir (fidaxomicin; Optimer Pharmaceuticals/Astellas Pharma), 2011

Table: Tedizolid phosphate (Trius Therapeutics/Dong-A Pharmaceutical/Bayer) – drug profile, 2011

Table: Summary of the key Phase II clinical trial for tedizolid phosphate (TR-701) in the treatment of cSSSI, 2011

Table: Phase III trial (TR701-113) to determine the efficacy of intravenous to oral TR-701 versus intravenous to oral linezolid in ABSSSIs, 2011

Table: Ability of tedizolid phosphate (TR-701) to meet unmet needs, 2011

Table: Datamonitor drug assessment summary of tedizolid phosphate (Trius Therapeutics/Dong-A Pharmaceutical/Bayer), 2011

Table: PTK 0796 (Paratek Pharmaceuticals) – drug profile, 2011

Table: Summary of the key Phase II clinical trial for PTK 0796 in the treatment of cSSSI, 2011

Table: Ability of PTK 0796 to meet unmet needs, 2011

Table: : Datamonitor drug assessment summary of PTK 0796 (Paratek Pharmaceuticals), 2011

Table: Dalbavancin (Durata Therapeutics) – drug profile, 2011

Table: Summary of early Phase III clinical trials for dalbavancin in the treatment of cSSSI, 2011

Table: Phase III trials (DISCOVER-1 and DISCOVER-2) to determine the efficacy of dalbavancin versus vancomycin and linezolid in ABSSSI, 2011

Table: Ability of dalbavancin to meet unmet needs, 2011

Table: Datamonitor drug assessment summary of dalbavancin (Durata Therapeutics), 2011

Table: Oritavancin (The Medicines Company) – drug profile, 2011

Table: Summary of early key Phase III clinical trials for oritavancin in the treatment of cSSSI, 2011

Table: Phase III trials (SOLO I and SOLO II) to determine the efficacy of oritavancin versus vancomycin in ABSSSI, 2011

Table: Ability of oritavancin to meet unmet needs, 2011

Table: Datamonitor drug assessment summary of oritavancin (The Medicines Company), 2011

Table: CXA-201 (CXA-101/tazobactam; Cubist Pharmaceuticals) – drug profile, 2011

Table: Summary of the key Phase II clinical trials for CXA-101 and CXA-201 (CXA-101/tazobactam) in the treatment of cUTIs and cIAIs, 2011

Table: Phase III trials (CXA-cUTI-10-04 and CXA-cUTI-10-05) to determine the efficacy of CXA-201 versus levofloxacin in cUTI, 2011

Table: Phase III trials (CXA-cIAI-10-08 and CXA-cIAI-10-09) to determine the efficacy of CXA-201 versus meropenem in cIAI, 2011

Table: Ability of CXA-201 (CXA-101/tazobactam) to meet unmet needs, 2011

Table: Datamonitor drug assessment summary of CXA-201 (CXA-201/tazobactam; Cubist Pharmaceuticals), 2011

Table: CAZ-AVI (ceftazidime/avibactam; Forest Laboratories/AstraZeneca) – drug profile, 2011

Table: Summary of the key Phase II clinical trials for CAZ-AVI (ceftazidime/avibactam) in the treatment of cIAIs and cUTIs, 2011

Table: Ability of CAZ-AVI (ceftazidime/avibactam) to meet unmet needs, 2011

Table: Datamonitor drug assessment summary of CAZ-AVI (ceftazidime/avibactam; Forest Laboratories/AstraZeneca), 2011

FIGURESFigure: Teflaro/Zinforo (ceftaroline fosamil; Forest Laboratories/AstraZeneca) – SWOT analysis, 2011Figure: Datamonitor drug assessment summary of Teflaro/Zinforo (ceftaroline fosamil; Forest Laboratories/AstraZeneca), 2011Figure: Dificid/Dificlir (fidaxomicin; Optimer Pharmaceuticals/Astellas Pharma) – SWOT analysis, 2011Figure: Datamonitor drug assessment summary of Dificid/Dificlir (fidaxomicin; Optimer Pharmaceuticals/Astellas Pharma), 2011Figure: Tedizolid phosphate (Trius Therapeutics/Dong-A Pharmaceutical/Bayer) – SWOT analysis, 2011Figure: Datamonitor drug assessment summary of tedizolid phosphate (Trius Therapeutics/Dong-A Pharmaceutical/Bayer), 2011Figure: Phase II trial of PTK 0796 versus linezolid in treatment of complicated skin and skin structure infections, 2011Figure: PTK 0796 (Paratek Pharmaceuticals) – SWOT analysis, 2011Figure: Datamonitor drug assessment summary of PTK 0796 (Paratek Pharmaceuticals), 2011Figure: Dalbavancin (Durata Therapeutics) – SWOT analysis, 2011Figure: Datamonitor drug assessment summary of dalbavancin (Durata Therapeutics), 2011Figure: Oritavancin (The Medicines Company) – SWOT analysis, 2011Figure: Datamonitor drug assessment summary of oritavancin (The Medicines Company), 2011Figure: CXA-201 (CXA-101/tazobactam; Cubist Pharmaceuticals) – SWOT analysis, 2011Figure: Datamonitor drug assessment summary of CXA-201 (CXA-201/tazobactam; Cubist Pharmaceuticals), 2011Figure: CAZ-AVI (ceftazidime/avibactam; Forest Laboratories/AstraZeneca) – SWOT analysis, 2011Figure: Datamonitor drug assessment summary of CAZ-AVI (ceftazidime/avibactam; Forest Laboratories/AstraZeneca), 2011Figure: The PharmaVitae ExplorerCompanies mentioned Abbott Laboratories, Delta Air Lines, Inc., Devoteam SA, GlaxoSmithKline Plc, Health Protection Agency, Hutchison 3G UK Limited, Johnson & Johnson, Novartis AG, Texas Instruments Incorporated, The Medicines Company

To order this report: Drug and Medication Industry: Product Profiles: Pipeline Antibacterials – Gram-negative combination antibiotics show promise in MRSA-focused pipeline

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