Industry Outlook: Trends in Respiratory Disease Strategies

Published by: Decision Resources

Published: Nov. 1, 2011

Table of Contents

Executive Summary

Strategic Considerations

Stakeholder Implications

Introduction

Respiratory Diseases

Common Respiratory Diseases

Rare Respiratory Diseases

Respiratory Disease Market

Blockbuster Brands

Leading Respiratory Franchises

U.S. Physician Survey Findings

Current Practice Dynamics

Physician Opinion on Generic Respiratory Drugs

Unmet Needs

Asthma and Chronic Obstructive Pulmonary Disease

Cystic Fibrosis and Interstitial Lung Disease

Company Strategies

AstraZeneca

Boehringer Ingelheim

GlaxoSmithKline

Merck & Co.

Novartis

Outlook

About the Author

Look for relevant insight within these Spectrum series and related Spectrum reports:

Abstract

• Recent regulatory failures have demonstrated an increased emphasis on safety versus efficacy. Cardiac safety is an area of major focus, given that it is a leading cause of drug discontinuation and withdrawal in the major markets. How have regulatory cardiac safety requirements evolved? What dedicated cardiac safety tests must developers perform during drug development?
• The FDA is planning a general advisory committee meeting in early 2012 to specifically address cardiovascular assessments for obesity agents in development. What clues do the regulatory challenges faced by Orexigen/Takeda's Contrave and Arena/Eisai's Lorqess give to potential developers of obesity agents?
• Postmarketing initiatives will help to reduce the risk of cardiac adverse events. How have companies utilized REMS to address regulatory concerns? How have REMS been used to limit cardiovascular risk?

• Regulatory environment: The FDA and the International Conference on Harmonisation guidelines, preclinical and clinical cardiac safety assessments.
• Postmarketing surveillance: Risk Evaluation and Mitigation Strategies (REMS).
• Strategies to reduce the regulatory burden of demonstrating CV safety: Public-private partnerships, modeling of cardiovascular outcomes trials.
• Insight: Author Matthew Killeen, Ph.D., has published numerous journal articles on topics including sudden cardiac death and atrial fibrillation. He also has written a book on the role of cardiac safety in drug development, "Cardiac Drug Safety: A Bench to Bedside Approach." Dr. Killeen holds a doctorate in cardiac electrophysiology from Cambridge University. In addition to being a member of the Cardiac Safety Research Consortium, an initiative formed by the FDA and Duke University, he has spoken at FDA conferences on topics including drug safety and pharmaceutical development.

About MarketResearch.com
MarketResearch.com is an online aggregator selling over 400,000 market research reports, company profiles and country profiles from over 720 research firms. Our reports will provide you with the critical business and competitive intelligence you need for strategic planning and marketing research. Coverage includes the US, UK, Europe, Asia and global markets.