Cubist’s CXA-201 is a first-line intravenous antibiotic combination of a novel cephalosporin (CXA-101) and a generic β-lactamase inhibitor - tazobactam - for the treatment of serious Gram negative bacterial infections. CXA-201 does not have a completely new mechanism of action, and it is not active against all mechanisms of resistance, but it offers enhanced activity against some key resistant Gram negative pathogens, and particularly strong activity against P. aeruginosa. This report reviews CXA-201’s clinical profile and potential, emerging competition, as well as the market opportunity and commercial prospects for this new antibiotic in the empirical Gram negative treatment setting.

Published: September 23rd, 2011

Number of pages: 34

Author: Dr. Ilana Fogelman

TABLE OF CONTENTS:

INTRODUCTION
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1. The growing problem of antibiotic resistance
2. Gram negative bacteria
- Gram negative nosocomial Infections
3. Main mechanisms of resistance in Gram negative bacteria
- β-lactamase production – the most prevalent resistance mechanism
- Various resistance mechanisms influence each other
4. Pseudomonas aeruginosa and mechanisms of resistance
5. Treatment recommendations for Gram negative infections
6. The role of beta lactam antibiotics/β-lactamase inhibitor combinations

DEVELOPMENT OF CXA-101 AND CXA-201
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1. CXA-101
- Microbiologic assessment
- Pharmacokinetics
- Phase II trial of CXA-101 in cUTI
2. CXA-201
- Animal proof-of-concept study
- Pharmacokinetics of CXA-201
- CXA-201 phase II trial in cIAI recently completed
3. Pivotal Phase III trials in cUTI

OPINION
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1. How strong is the rationale
2. What can we learn from the in vitro testing
3. Predictors of clinical efficacy
4. The profile of CXA-101 as a stand-alone agent
5. CXA-201 broadens coverage but holes remain
6. Current us regulatory considerations

COMPETITIVE LANDSCAPE
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1. Novel β-lactam antibiotic/ β -lactamase inhibitor combinations
- NXL104 (Avibactam; AstraZeneca and Forest Laboratories):
2. Novel antibiotics targeting Gram negative infections
3. Pipeline products targeting Pseudomonas aeruginosa

THE MARKET OPPORTUNITY
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1. Less Profit, Fewer Drugs
2. CXA-201’s revenue potential
3. Empirical treatment market opportunity

CONCLUSION
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