R&D Trends: Skin and soft tissue infections - MRSA threat drives R&D interest in an increasingly fragmented market

Introduction

Despite the widespread use of vancomycin, the market for new drugs to treat SSTIs in hospitalized patients remains lucrative. However, with a busy late-stage pipeline, new products will have to show significant competitive advantages in order to gain market share as cost competition increases. Regulatory demands and uncertainty in the key US market remain a source of concern for developers.

Features and benefits

* Overview of the clinical pipeline for SSTIs along with an assessment of key R&D trends
* Analysis of the new FDA guidance for SSTI drugs and its potential impact on drug development in this area
* Assessment of major factors influencing the therapeutic landscape for SSTI drugs, including key factors for success and areas of unmet need
* Review of feedback from key opinion leaders on the future of SSTI therapy

Highlights

The spread of hospital and community-acquired strains of MRSA is driving R&D interest for SSTIs, despite the continued use of vancomycin as first-line therapy. The late-stage pipeline includes drugs with competitive advantages over both vancomycin and linezolid, although cost is becoming an increasingly important factor in treatment choice.
The new draft FDA guidance for SSTI clinical trials will have considerable implications for drug developers. Clinical trial design will have to be adapted to incorporate the new primary endpoint, the clinical relevance of which has been widely questioned, while the lack of a defined non-inferiority margin will create uncertainty for drug companies.
Antimicrobial resistance will be the key factor shaping the SSTI market over the next decade. New market entries with convenient oral dosing will have strong utility against community-acquired MRSA infections. Much-needed new classes of drugs are in early and mid-stage clinical trials, as small companies take the lead in SSTI drug development.

Your key questions answered

* Gain insight into key trends in the pipeline, drug classes currently in development, and company dynamics for SSTIs.
* Assess the impact of the new FDA draft guidance for SSTI drug development and its implications for companies conducting late-stage clinical trials.
* Understand the future therapeutic landscape for SSTIs, the impact of antimicrobial resistance and key success factors for new market entrants.
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Executive Summary
Strategic scoping and focus
Datamonitor key findings
Related reports
OVERVIEW
Catalyst
Summary
CLINICAL PIPELINE OVERVIEW
Skin and soft tissue infections are at the center of antibacterial drug development
New drugs targeting MRSA represent the most commercially attractive opportunity for antibacterial drug developers in SSTIs
Small companies now play an increasing role in antibacterial drug development
Product failure rates in clinical development are lower for antibacterial drugs than in other therapy areas
New antibacterial classes are in development for SSTIs, although none of these products will reach the market for at least 5 years
An increasingly challenging regulatory environment has caused problems for a number of antibacterial therapies in Phase III clinical trials, with Pfizer’s dalbavancin the most significantly affected
Recently discontinued drugs
TARGET PRODUCT PROFILE
Vancocin/various (vancomycin; ViroPharma/Eli Lilly/Flynn Pharma/various)
Vancomycin remains the gold-standard therapy for serious skin and soft tissue infections in hospitalized patients
Zyvox (linezolid; Pfizer)
Linezolid has set the benchmark for oral anti-MRSA drugs
Target product profile versus current level of attainment
CLINICAL TRIAL DESIGN IN SKIN AND SOFT TISSUE INFECTIONS
Regulatory uncertainty has led to significant development challenges for a number of skin and soft tissue drug candidates
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Key opinion leaders expect the EMA to retain the use of clinical cure/clinical response at test of cure as the primary endpoint for SSTI drug clinical trials
Preclinical trials
Clinical trials
Clinical endpoints
Future developments in clinical trial design
INNOVATIVE EARLY-STAGE APPROACHES
New classes of antibacterial drugs and novel therapies from existing classes are the most promising early-stage approach in SSTIs
Biologic therapies are being investigated for bacterial infections, although developments lag far behind those in cancer and autoimmune disorders
Vaccines against Staphylococcus aureus are in clinical trials, although progress has been disappointing so far
Bacteriophage therapy shows early stage promise for bacterial infections, although key opinion leaders remain unconvinced
THE FUTURE OF TREATMENT IN SKIN AND SOFT TISSUE INFECTIONS
Antimicrobial resistance will be the most important factor shaping the treatment of skin and soft tissue infections over the next decade
The threat posed by MRSA will grow over the coming years, with community-acquired strains representing the greatest problem
The gold standard, vancomycin, is losing its efficacy for treating SSTIs caused by MRSA
There is increasing R&D interest in improving the clinical properties of existing beta-lactam drugs through combination with a novel beta-lactamase inhibitor
Small companies will dominate antibacterial drug development over the next decade
Cubist Pharmaceuticals demonstrates the potential for small companies developing antibacterial drugs in areas of key unmet need
Modest sales of a new SSTI drug can represent significant revenues for a small company lacking high expenditure on R&D, sales, and marketing
A number of new drugs will reach the market over the next 10 years, fragmenting the market and reducing the commercial potential for new products
Physicians strongly desire more oral therapies for SSTIs
Trius Therapeutics’ torezolid shows a number of competitive advantages of linezolid, although the drug currently lacks a partner with strong sales and marketing capabilities
Novartis’s and Paratek Pharmaceuticals’ PTK 0796 has dual oral and intravenous formulations and broader pathogen coverage than many anti-MRSA therapies
BIBLIOGRAPHY
Journal papers
Websites
APPENDIX
Contributing experts
Conferences attended
Report methodology
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