MRSA Drug Futures

Date: September 22, 2010
Pages: 107
Price:
US$ 1,740.00
Publisher: Espicom Business Intelligence
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: M96894FA16DEN
Leaflet:

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MRSA Drug Futures
MRSA: a complex issue
MRSA infection - especially the hospital acquired variety - has been front page news for some years, but reports of falling rates of infection in the US and Europe masks the real situation as far as drug treatments are concerned. Changes to clinical practice and attitudes to hygiene have played a significant part in reducing the incidence of MRSA. There remains the unresolved, but improving issue of the inappropriate over prescription of antibiotics and the resulting growth in resistance to many front line therapies. Despite progress, the fact remains that the arsenal of drugs available to treat MRSA remains limited.

Current therapies and future approaches
It’s not all bad news. A number of drugs with different mechanisms of action have been approved for the treatment of infections caused by MRSA and there is a mixture of antibiotic classes in development for MRSA, including older ones, such as glycopeptides, modified versions of older classes, such as neoglycosides, and combinations, such as heterodimers (betalactam+glycopeptide).

The problem of ever-evolving resistance remains, and it is only a matter of time before the resourceful bacteria evolve once again to become resistant to novel antibiotic classes. It is in this regard that perhaps immunotherapies and vaccines may be the real key to success against MRSA.

The future MRSA landscape
Three new products expected to launch from 2011 will add US$1.1 billion to the sector’s value taking the total MRSA market to in excess of US$4.1 billion. Pfizer will continue to dominate but its percentage share will diminish: declining revenues from Zyvox will be offset by increasing sales of Tygacil which will result in a small decline in overall revenues. At the same time Cubist Pharmaceuticals’ Cubicin and LEO Pharma’s Fucidin are expected to show strong growth, the former becoming the most valuable product for treating MRSA with almost blockbuster sales of US$911 million in 2016.

Of the new products expected to launch, Paratek Pharmaceuticals/Novartis’ PTK 0796 has an 80% chance of reaching the market, largely due to the drug’s advantageous mode of action and proof of concept and is forecast to achieve sales of US$454 million by 2016.

Squaring the circle?

The inherent commercial problems of developing an antibiotic which, by its nature, could be redundant in a short amount of time has not encouraged a great deal of the industry’s R&D spend to be invested in this area. However the spectre of ever mutating MRSA (and similar) pathogens leading to the uncontrolled spread of infection is possible. Pharma - and government - need to invest more in antibiotic R&D with the aim of developing drugs that work in new ways to attempt to avoid resistance development. In the US, the Infectious Diseases Society of America has suggested a number of incentives related to IP protection, tax breaks and funding to encourage industry to tackle more effectively this critical area.

This new 105+ page August 2010 report provides a complete briefing on MRSA and the companies, products and research that are shaping the sectors future More Information...

The benefits of this report:
  • A comprehensive review of MRSA putting the pathogen into its research and clinical context
  • Original analysis and 5-year sales forecasting for 11 launched and Phase III products
  • An assessment of 5 promising Phase II pipeline prospects
  • Novel, critical evaluation and scoring of each product
With this report you can...
  • Understand the role of staphylococcus aureus
  • Know the differing risk factors of HA-MRSA and CA-MRSA
  • Know how MRSA manifests itself
  • Understand how bacterial mutation occurs and resistance develops
  • Evaluate trends in US prevalence of MRSA and assess which European countries have the highest/lowest incidence rates
  • Understand the arguments around research funding and the incentives for the industry which are proposed in the US
  • Review current product offerings: there are 8 products from 7 companies - what are they?
Questions answered...
  • What development hurdles must Basilia overcome with Zeftera?
  • What clinical advantages does Cubist’s Cubicin has over its competitors?
  • To what degree will Pfizer’s Zyvox be affected by generic competition in 2015?
  • What are the prospects and challenges for Forest’s new
Therapeutic approaches
  • Beta-lactum
  • Glycopeptides
  • Macrolides
  • Streptogramins
  • Aminoglycosides
EXECUTIVE SUMMARY

MRSA OVERVIEW

Bacteria
  Staphylococcus aureus
Genetics
MRSA Infection
  How Does MRSA Infection Typically Manifest?
  Community-acquired Versus Hospital-acquired MRSA
How Does Resistance to Antibiotics Develop?
  Why is Resistance Now Such a Problem?
Patient Statistics
  MRSA in the US
  MRSA in Europe
What’s in the Current Arsenal?
Treatment Guidelines
  The Clinical Treatment Strategy
  The Bacteriologic Strategy
Changing Prescribing Habits
Incentives for Ph arma to Invest in Antibiotic Development
Conclusions

GLOBAL SALES FORECASTS TO 2016

COMPETITOR RATIO ANALYSIS

APPROVED PRODUCTS

Ceftobiprole
  Mode of Action
  Current Status
  Proof of Concept/Clinical Data
  Development Risks
  Company Expertise
  Competition within the Market-place
  Competitor Ratio Analysis
  Forecast
  Clinical Trial Results
Daptomycin
  Mode of Action
  Current Status
  Proof of Concept/Clinical Data
  Company Expertise
  Competition within the Market-place
  Patent Expiry
  Generic Competition
  Competitor Ratio Analysis
  Forecast
  Clinical Trial Results
Fusidic acid
  Mode of Action
  Current Status
  Proof of Concept/Clinical Data
  Development Risks
  Company Expertise
  Competition within the Market-place
  Competitor Ratio Analysis
  Forecast
  Clinical Trial Results
Linezolid
  Mode of Action
  Current Status
  Proof of Concept/Clinical Data
  Development Risks
  Company Expertise
  Competition within the Market-place
  Patent Expiry
  Generic Competition
  Competitor Ratio Analysis
  Forecast
  Clinical Trial Results
Teicoplanin
  Mode of Action
  Current Status
  Proof of Concept/Clinical Data
  Development Risks
  Company Expertise
  Competition within the Market-place
  Generic Competition
  Competitor Ratio Analysis
  Forecast
  Clinical Trial Results
Telavancin
  Mode of Action
  Current Status
  Proof of Concept/Clinical Data
  Development Risks
  Company Expertise
  Competition within the Market-place
  Data Exclusivity
  Patent Expiry
  Competitor Ratio Analysis
  Forecast
  Clinical Trial Results
Tigecycline
  Mode of Action
  Current Status
  Proof of Concept/Clinical Data
  Development Risks
  Company Expertise
  Competition within the Market-place
  Data Exclusivity
  Patent Expiry
  Generic Competition
  Competitor Ratio Analysis
  Forecast
  Clinical Trial Results
Vancomycin
  Mode of Action
  Current Status
  Development Risks
  Company Expertise
  Competition within the Market-place
  Generic Competition
  Competitor Ratio Analysis
  Forecast

PHASE III PRODUCTS

Ceftaroline
  Mode of Action
  Current Status
  Proof of Concept/Clinical Data
  Development Risks
  Company Expertise
  Competition within the Market-place
  Competitor Ratio Analysis
  Forecast
  Clinical Trial Results
Dalbavancin
  Mode of Action
  Current Status
  Proof of Concept/Clinical Data
  Development Risks
  Company Expertise
  Competition within the Market-place
  Competitor Ratio Analysis
  Clinical Trial Results
Oritavancin
  Mode of Action
  Current Status
  Proof of Concept/Clinical Data
  Development Risks
  Company Expertise
  Competition within the Market-place
  Competitor Ratio Analysis
  Clinical Trial Results
PTK 0796
  Mode of Action
  Current Status
  Proof of Concept/Clinical Data
  Development Risks
  Company Expertise
  Competition within the Market-place
  Competitor Ratio Analysis
  Forecast
  Clinical Trial Results

PHASE II/III PRODUCTS

Torezolid
  Mode of Action
  Current Status
  Proof of Concept/Clinical Data
  Development Risks
  Company Expertise
  Competition Within the Market-place
  Competitor Ratio Analysis
  Forecast
  Clinical Trial Results

PHASE II PRODUCTS

BC-3781
  Mode of Action
  Current Status
  Proof of Concept/Clinical Data
  Development Risks
  Company Expertise
  Competition within the Market-place
  Competitor Ratio Analysis
  Clinical Trial Results
Delafloxacin
  Mode of Action
  Current Status
  Proof of Concept/Clinical Data
  Development Risks
  Company Expertise
  Competition within the Market-place
  Competitor Ratio Analysis
  Clinical Trial Results
Iclaprim
  Mode of Action
  Current Status
  Proof of Concept/Clinical Data
  Development Risks
  Company Expertise
  Competition in the Market-place
  Competitor Ratio Analysis
  Clinical Trial Results
PTZ601
  Mode of Action
  Current Status
  Proof of Concept/Clinical Data
  Development Risks
  Company Expertise
  Competition within the Market-place
  Competitor Ratio Analysis
  Clinical Trial Results
TD-1792
  Mode of Action
  Current Status
  Proof of Concept/Clinical Data
  Development Risks
  Company Expertise
  Competition within the Market-place
  Competitor Ratio Analysis

APPENDIX 1

References

APPENDIX 2

Bibliography

APPENDIX 3

Competitor Ratio Analysis
  Competitor Ratio Analysis Criteria
  Competitor Ratio Analysis Score
  Espicom Drug Monograph Scores in Context

APPENDIX 4

Phase Transition Probability

LIST OF TABLES

Percentage of hVISA Isolates and Corresponding Vancomycin MIC
Highest and Lowest Values of Methicillin-Resistant Isolates in Europe in 2008
Summary of the Main Antibiotics and their Mechanisms of Action
Summary of Mutations found in S. aureus with Daptomycin MICs Above the Susceptible Range
Drugs Approved for the Treatment of MRSA Infections
Drugs in Development to Treat MRSA
CDC Steps to Aid in Prevention of Antimicrobial Resistance
Sales Forecasts of Current and Future Leading MRSA Drugs (US$ millions)
Summary of Competitor Ratio Analysis Scores
Zeftera Sales (2009-2016)
Cubist’s Sales of Cubicin by Indication (2008-2016)
Fucidin Sales (2008-2016)
Linezolid Sales by Region (2009-2016)
Cure Rates for the ITT Population with Confirmed Enterococcal Disease
Clinical Cure Rate for ME Linezolid-treated Patients
Results at Test-of-cure Visit
Test-of-cure Cure Rates for ME Patients with DFIs
Astellas’ Targocid Sales (2008-2016)
Vibativ Sales (2009-2016)
Tygacil Sales (2008-2016)
Vancomycin Sales by Company (2008-2016)
Ceftaroline Sales (2011-2016)
First Follow-up Visit Results from ARRD
First Follow-up Visit in the ARRI Study
PTK 0796 Sales (2013-2016)
Torezolid Sales (2013-2016)
Summary of ASSIST-1 and ASSIST-2 Data
Probability of Launch

LIST OF FIGURES & CHARTS

Typical Structures Contained within Gram-positive and -negative Bacteria
Staphylococcus aureus
The Three Main Methods of Genetic Information Exchange for Bacteria
Number of Invasive MRSA Cases and Deaths
Proportion of S. aureus Bacteria Shown to be Methicillin Resistant in Each Country
Relationship Between the Percentage of Methicillin-Resistant Bacteria and Antibiotic Consumption
Antibiotic Targets in the Bacterium
Predicted Sales Figures for Launched MRSA Products
Predicted Sales Figures for Phase III MRSA Products
Chemical Structure of Ceftobiprole
Zeftera Sales (2009-2016)
Chemical Structure of Daptomycin
Cubist's Sales of Cubicin (2008-2016)
Chemical Structure of Sodium Fusidate
Fucidin Sales (2008-2016)
Chemical Structure of Linezolid
Zyvox Sales (2008-2016)
Astellas' Targocid Sales (2008-2016)
Chemical Structure of Telavancin
Vibativ Sales (2009-2016)
Chemical Structure of Tigecycline
Tygacil Sales (2008-2016)
Chemical Structure of Vancomycin
Vancomycin Sales by Company (2008-2016)
Chemical Structure of Ceftaroline
Ceftaroline Sales (2011-2016)
Chemical Structure of Dalbavancin
Chemical Structure of Oritavancin
PTK 0796 Sales (2013-2016)
Chemical Structure of Torezolid
Torezolid Sales (2008-2016)
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