Product Profiles: Pipeline Antibacterials – Gram-negative combination antibiotics show promise in MRSA-focused pipeline

2012-01-23
Published : Jan-2012

Report Summary

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.

Highlights

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.

Features and benefits

  • Extensive analysis of clinical trial data and assessment of clinical and commercial attractiveness for pipeline antibacterials
  • Discussion of future strategic opportunities to achieve success in an increasingly crowded antibacterials market
  • Analysis of the ability of pipeline drugs to satisfy key unmet needs in the antibacterials space

Product Profiles: Pipeline Antibacterials – Gram-negative combination antibiotics show promise in MRSA-focused pipeline

Published: January 2012
No.OF Pages: 111
Price: Single User License – US$ 11400      Corporate User License US$ 28500

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Table of Contents

OVERVIEW
Catalyst
Summary

EXECUTIVE SUMMARY
Strategic scoping and focus
Datamonitor key findings
Related reports

PRODUCT OVERVIEW
Key pipeline products for antibacterials

PIPELINE PRODUCT PROFILES
Teflaro/Zinforo (ceftaroline fosamil; Forest Laboratories/AstraZeneca)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Clinical and commercial attractiveness
Dificid/Dificlir (fidaxomicin; Optimer Pharmaceuticals/Astellas Pharma)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Clinical and commercial attractiveness
Tedizolid phosphate (Trius Therapeutics/Dong-A Pharmaceutical/Bayer)
Drug profile
Development overview
Ongoing clinical trials
SWOT analysis
Satisfaction of unmet needs
Clinical and commercial attractiveness
PTK 0796 (Paratek Pharmaceuticals)
Drug profile
Development overview
Ongoing clinical trials
SWOT analysis
Satisfaction of unmet needs
Clinical and commercial attractiveness
Dalbavancin (Durata Therapeutics)
Drug profile
Development overview
Ongoing clinical trials
SWOT analysis
Satisfaction of unmet needs
Clinical and commercial attractiveness
Oritavancin (The Medicines Company)
Drug profile
Development overview
Ongoing clinical trials
SWOT analysis
Satisfaction of unmet needs
Clinical and commercial attractiveness
CXA-201 (CXA-101/tazobactam; Cubist Pharmaceuticals)
Drug profile
Development overview
Ongoing clinical trials
SWOT analysis
Satisfaction of unmet needs
Clinical and commercial attractiveness
CAZ-AVI (ceftazidime/avibactam; Forest Laboratories/AstraZeneca)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Clinical and commercial attractiveness
Other pipeline antibacterials
CB-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)
BIBLIOGRAPHY
Journal papers
Websites
Datamonitor reports

APPENDIX
PharmaVitae Explorer database
Contributing experts
Conferences attended
Report methodology

List of Tables & Figures

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