Adult OM/PJI due to MRSA are among the most hard-to-treat MRSA infections due to the difficulties for the body’s natural infection-fighting cells and antibiotics to reach the infected tissues in the bones. However, there is no guidance published by the FDA or the EMA to help drug developers to design clinical trials testing antibiotics for OM/PJI. Indeed, no new antibiotic has been approved for the treatment of OM/PJI by the FDA or EMA in the last two decade, and only a few clinical trials have been conducted to evaluate antibiotics’ efficacy and safety/tolerability for OM/PJI. The lack of approved labels and the paucity of relevant clinical efficacy and safety data force managing physicians to rely on their own experience to select antibiotics for a protracted therapy required for adult OM/PJI due to MRSA, representing a significant unmet need in this field.

Questions answered:

  • What are the treatment drivers and goals for adult OM/PJI due to MRSA?
  • What attributes are key influencers, which have limited impact, and which are hidden opportunities?
  • How do current therapies perform on key treatment drivers and goals for adult OM/PJI due to MRSA?
  • What are the prevailing areas of unmet need and opportunity in adult OM/PJI due to MRSA?
  • What trade-offs across different clinical attributes and price are acceptable to U.S. and European ID specialists for a hypothetical new drug for adult OM/PJI due to MRSA?

Markets covered: United States, United Kingdom, France, Germany

Primary research: Survey of 60 U.S. and 31 European ID specialists fielded in January 2017

Key companies: Allergan, Cempra, Merck, Pfizer

Key drugs: vancomycin, daptomycin, dalbavancin, linezolid, ceftaroline, Taksta, rifampin, TMP/SMX

Table of contents

  • Methicillin-Resistant Staphylococcus Aureus Infections - Unmet Need - Detailed, Expanded Analysis (US & EU)
    • Key Updates
      • December 2017
      • September 2017
      • June 2017
    • Treatment Drivers and Goals
      • Overview
      • Rationale for Treatment Drivers and Goals Selection
        • Efficacy
        • Safety and Tolerability
        • Convenience of Administration
        • Nonclinical Factors
      • Physician Rating of Treatment Drivers and Goals in Adult Osteomyelitis /Prosthetic Joint Infections due to Methicillin-Resistant Staphylococcus Aureus
        • Importance of Efficacy Attributes to Prescribing Decisions in Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA: United States
        • Importance of Efficacy Attributes to Prescribing Decisions in Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA: Europe
        • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA: United States
        • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA: Europe
        • Importance of Convenience of Administration Attributes to Prescribing Decisions in Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA: United States
        • Importance of Convenience of Administration Attributes to Prescribing Decisions in Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA: Europe
        • Importance of Nonclinical Factors to Prescribing Decisions in Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA: United States
        • Importance of Nonclinical Factors to Prescribing Decisions in Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA: Europe
      • Stated Versus Derived Importance of Treatment Drivers and Goals
        • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA: United States
        • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA: Europe
    • Product Performance Against Treatment Drivers and Goals
      • Overview
      • Rationale for Drug Selection
        • Products for Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA
      • Current Brand Performance on Key Treatment Drivers and Goals
        • Overall Performance of Key Therapies for Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA: United States
        • Overall Performance of Key Therapies for Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA: Europe
        • Relative Performance of Key Therapies for Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA Across Select Efficacy Attributes: United States
        • Relative Performance of Key Therapies for Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA Across Select Efficacy Attributes: Europe
        • Relative Performance of Key Therapies for Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA Across Select Safety and Tolerability Attributes: United States
        • Relative Performance of Key Therapies for Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA Across Select Safety and Tolerability Attributes: Europe
        • Relative Performance of Key Therapies for Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA Across Select Convenience of Administration Attributes: United States
        • Relative Performance of Key Therapies for Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA Across Select Convenience of Administration Attributes: Europe
        • Relative Performance of Key Therapies for Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA Across Select Nonclinical Attributes: United States
        • Relative Performance of Key Therapies for Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA Across Select Nonclinical Attributes: Europe
    • Assessment of Unmet Need
      • Overview
      • Overall Satisfaction with Current Treatment
        • Surveyed ID Specialists’ Satisfaction with Performance of Key Therapies for Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: United States
        • Surveyed ID Specialists’ Satisfaction with Performance of Key Therapies for Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: Europe
      • Physician Rating of Unmet Need in Adult Osteomyelitis/Prosthetic Joint Infections Due to Methicillin-Resistant Staphylococcus Aureus
        • Surveyed ID Specialists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA: United States
        • Surveyed ID Specialists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA: Europe
        • Surveyed ID Specialists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA: United States
        • Surveyed ID Specialists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA: Europe
        • Surveyed ID Specialists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA: United States
        • Surveyed ID Specialists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA: Europe
        • Surveyed ID Specialists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA: United States
        • Surveyed ID Specialists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA: Europe
      • Unmet Need in Adult Osteomyelitis/Prosthetic Joint Infections Due to Methicillin-Resistant Staphylococcus Aureus and Related Indications
        • Surveyed ID Specialists' Ascribed Level of Unmet Need in Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA and Related Indications: United States
        • Surveyed ID Specialists' Ascribed Level of Unmet Need in Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA and Related Indications: Europe
    • Opportunity Analysis
      • Areas of Opportunity in the Adult Osteomyelitis/Prosthetic Infections due to Methicillin-Resistant Staphylococcus Aureus Market and Emerging Therapy Insights
        • Opportunity: Regulatory Agency Approval for Antibiotics with Proven Efficacy and Safety in Osteomyelitis/Prosthetic Joint Infections
        • Opportunity: Safe and Effective Therapies with an Oral Formulation and/or Less-Frequent Dosing
    • Target Product Profiles
      • Assessing Drug Development Opportunities
      • Target Product Profile Methodology
        • Attributes and Attribute Levels
      • Attribute Importance and Part-Worth Utilities
        • Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA Target Product Profile: Attribute Importance
        • Spectrum of Coverage
        • Clinical Remission Rate Six Months After End of Treatment
        • Antibiofilm Activity Against Staphylococcus Aureus: Minimal Biofilm Eradicaton Concentration
        • Maximum Treatment Duration with Minimal Risk of Antibiotic-Related Severe Adverse Events
        • Formulation and Dosing Frequency
        • Regulatory-Approved Label for Osteomyelitis/Prosthetic Joint Infections or Data Available from Phase II/III Trials
        • Price per Treated Day
      • Conjoint Analysis-Based Simulations of Market Scenarios
        • Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 1
        • Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 1
        • Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA Market Simulations: Target Product Profiles Included in Scenario 1
        • Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 2
        • Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 2
        • Adult Osteomyelitis/Prosthetic Joint Infections Due to MRSA Market Simulations: Target Product Profiles Included in Scenario 2
    • Appendix
      • Key Abbreviations
      • Bibliography

Author(s): Jiamin Zhuo, Ph.D.

Jiamin Zhuo, Ph.D., is a business insights analyst on the Infectious, Niche, and Rare Diseases team at DRG, part of Clarivate. He provides expert insight into the commercial aspects of drug development and market dynamics in bacterial infections, including gram-negative infections and Methicillin-resistant Staphylococcus aureus. He earned his Ph.D. at the Mayo Graduate School of the Mayo Clinic in Minnesota and his B.Sc. in physiology from Peking University in China. Prior to joining DRG, Dr. Zhuo was a postdoctoral fellow at Boston University and MIT, where he gained extensive experience in quantitative research methods.