Case Study: Sepsis - Xigris’ disappointing performance creates a market opportunity for improved sepsis therapies

Introduction

Sepsis has high mortality levels; however, only few therapeutic strategies exist. The Surviving Sepsis Campaign (SSC) has helped to increase global awareness, standardize patient care, and reduce levels of mortality for sepsis. Negative clinical trial data have dented the commercial performance of Eli Lilly’s Xigris, creating an opportunity for improved sepsis therapeutics.

Features and benefits

• Profile and clinical and commercial evaluation of Eli Lilly’s Xigris (drotrecogin alfa [activated]).
• Review of unmet needs for sepsis and future challenges and opportunities in sepsis diagnosis and treatment.
• Overview of the Surviving Sepsis Campaign, including an evaluation of its impact on sepsis patient care.

Highlights

Eli Lilly’s Xigris is currently the only marketed direct therapy for sepsis. However, its commercial performance has been disappointing, despite its market monopoly, due to negative results from clinical trials conducted post-approval. Upcoming results from the PROWESS-SHOCK trial are likely to be critical to the future success of the drug.

There is a high unmet need for the identification and utilization of sepsis biomarkers that can identify those patients who would most likely benefit from new drugs and monitor patient response to therapies. However, current approaches lack the required predictive capability and reliability to be employed in clinical practice.

The Surviving Sepsis Campaign (SSC) has proved successful in increasing global awareness of sepsis, standardizing patient care, and reducing patient mortality rates. However, the development of the SSC guidelines has been associated with controversy due to links with industry (particularly Eli Lilly).

Your key questions answered

• Understand the commercial and clinical attractiveness of Eli Lilly’s Xigris and the key reasons behind its disappointing commercial performance.
• Understand key unmet needs in sepsis and potential future developments in diagnosis and therapy.
• Gain insight into the Surviving Sepsis Campaign and its impact on sepsis management.

Table Of Contents

Executive Summary
Strategic scoping and focus
Datamonitor key findings
Related reports

OVERVIEW
Catalyst
Summary

TREATMENT GUIDELINES
The SSC guidelines aim to translate evidence-based patient management recommendations into clinical practice
The Surviving Sepsis Campaign
Upon initiation, the key aim of the SSC was to drive a significant reduction in mortality from severe sepsis and septic shock
The SSC has had a positive impact on standardizing and guiding sepsis patient care and reducing levels of mortality
Sources of funding, incorporation of Xigris in the SSC guidelines, and committee members’ links to Eli Lilly are among questions raised over the influence of industry on the SSC

PRODUCT PROFILE: XIGRIS
Drug profile
Historic sales overview
A restricted label and unfavorable clinical trial data have harmed the revenue potential of Xigris
Development overview
Clinical trial results for Xigris released since its launch have proved harmful to its commercial performance
SWOT analysis
A range of clinical weaknesses will continue to harm the commercial prospects for Xigris, despite large markets and significant opportunities for the drug
Product positioning
Reduction in mortality in critically ill patients is the key brand message for Xigris
Physician perception of Xigris
Despite its well-publicised drawbacks, physicians recognize that Xigris is an efficacious drug in the patient group for which it is indicated
Clinical and commercial attractiveness
A restricted label and safety issues limit the market opportunity for sepsis, despite a large potential patient population
The strong sales and marketing capabilities of Eli Lilly and a clear brand message have been unable to significantly lift sales of Xigris

UNMET NEEDS
With just one marketed therapy, there is a strong unmet need for new efficacious and safe sepsis drugs and therapeutic approaches
Improvements in clinical trial design would facilitate a more accurate evaluation of new sepsis drugs
Biomarkers may play a crucial future role in sepsis diagnosis and treatment, although substantial challenges remain before they can be integrated into clinical practice

BIBLIOGRAPHY
Journal papers
Websites

APPENDIX A
Data definitions, limitations, and assumptions
Exchange rates

APPENDIX B
Contributing experts
Conferences attended
Report methodology