肺動脈高血圧症がもたらす新薬、既存薬への機会

Abstract

Introduction

Pulmonary arterial hypertension (PAH) is a rare but fatal disease that severely compromises pulmonary and cardiovascular function. New treatment guidelines and increasing awareness of PAH are rapidly expanding the treatable patient population. Once the exclusive domain of specialty pharma and small biotech fi rms, PAH is now attracting the attention of a wider scope of companies looking to enter this compact but lucrative market.

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Actelion's Tracleer (bosentan) was the fi rst oral drug to gain widespread approval for PAH and is currently the dominant player in the PAH market. However, a signifi cant need for conveniently formulated, effi cacious, and reasonably priced alternatives remains.

Which agents-established and emerging-are poised to challenge Tracleer?

A growing treatable patient population and a shift from monotherapy to a multimodal treatment approach are expanding the PAH market.

What other attractive qualities does the PAH market have, and what opportunities does it present for drug manufacturers?

Pfizer has expanded the reach of its lifestyle drug Viagra (sildenafi l) by gaining approval to include PAH in its list of indications.

Which other manufacturers plan to follow the same strategy with their established therapies?

Scope

• Overview of PAH: disease characteristics, diagnosis, prevalent cases, risk factors, disease pathways, and drug targets.
• Approved drug therapies: Flolan, Tracleer, Revatio, Remodulin, Ventavis, Procylin, combination therapy.
• Promising new therapies: novel endothelin receptor antagonists, reformulated prostacyclin analogues, PDE-5 inhibitors, vasoactive intestinal peptide derivatives, serotonin pathway antagonists, tyrosine kinase inhibitors, and others.
• Outlook: market drivers and constraints, and forecast of the PAH market through 2010.

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Companies

• Actelion
• Astellas Pharma
• Bayer-Schering AG
• Biogen Idec
• Cotherix
• Eli Lilly
• Encysive
• Epix
• Forest
• Gilead Sciences
• GlaxoSmithKline
• ICOS
• Kaken Pharmaceuticals
• Lundbeck
• mondoBiotech
• Myogen
• Novartis
• Pfi zer
• PR Pharmaceuticals
• United Therapeutics

Table of Contents

• Executive Summary
• Strategic Considerations
• Stakeholder Implications
• An Attractive Target
• Overview of PAH
• Disease Characteristics, Diagnosis, and Prevalent Cases
• Risk Factors, Disease Pathways, and Drug Targets
• Approved Drug Therapies
• Flolan
• Tracleer
• Revatio
• Remodulin
• Ventavis
• Other Drug Therapies
• Combination Therapy
• Promising New Therapies
• Novel Endothelin Receptor Antagonists: Ambrisentan vs Thelin
• Reformulated Prostacyclin Analogues: Inhaled and Oral Remodulin
• PDE-5 Inhibitors: Cialis, Levitra, and UK-369003
• Vasoactive Intestinal Peptide Derivatives: Aviptadil
• Serotonin Pathway Antagonists: PRX-08066 and Cipralex/Lexapro
• Tyrosine Kinase Inhibitors: Gleevec
• Other Promising Pipeline Agents
• Outlook
• Market Drivers and Constraints
• Pulmonary Arterial Hypertension Market Through 2010

Tables

• 1. Prevalence of Pulmonary Arterial Hypertension, 2005
• 2. Molecular Targets for Current and Future PAH Therapies
• 3. Major Marketed Drugs for PAH
• 4. Emerging Therapies for the Treatment of Pulmonary Hypertension
• 5. Approval Status of Current PAH Therapies
• 6. Forecast of Regional Sales of Major PAH Drug Classes, 2010

Figures

• 1. Classifications of Pulmonary Arterial Hypertension
• 2. Risk Factors for Pulmonary Arterial Hypertension
• 3. Market Share of Current PAH Therapies in the Seven Major Markets, 2005