標的療法と診断の共同開発

Abstract

Introduction

Drug-test (RxDx) companion products pair a drug and a diagnostic test that can tell physicians which patients will benefi t most from treatment with the drug. This report examines whether it is appropriate to ask pharmaceutical/biotech and diagnostics companies to develop these products when they may question what benefit they will receive from such development; after all, these companies are already developing good drugs and good tests to treat many people. We examine the FDA' s efforts to encourage development of RxDx products, possible incentives to both drug and diagnostics companies, the companies that we believe are currently suited to fi nd success, and what factors will likely play into this success.

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The benefi ts of RxDx companion products could be very high for individual patients and society. However, decisions in the drug and diagnostics industries are based on economics. What will development of such tests cost? How will companies know when it makes fi nancial sense to develop them?

Technology now exists to exploit the information in human genes to make better medicines that treat not just large patient populations but also individual patients through personalized medicine. How can drug and diagnostics companies best benefi t from this new knowledge? How can they strike a balance between public benefi t and company profit? Try as the FDA might to encourage the codevelopment of RxDx products, a lack of obvious economic benefi t to the pharmaceutical and diagnostics industries has caused these industries to drag their feet in the development of personalized medicine and RxDx products specifi cally. What incentives are being considering to encourage development of these products? Can the cost of development be decreased? Should pricing/reimbursement for RxDx products be increased? What other incentives are reasonable?

Decision Resources, Inc. 5-2

The goal of incentives to encourage development of RxDx products must be to balance the needs of many stakeholders-including patients, doctors, and payers as well as diagnostics and pharmaceutical/biotech companies. What monetary or legislative incentives can benefi t most stakeholders? Aside from economic considerations, what factors could stand in the way of development of these tests?

Scope

• Key codevelopment concepts: April 2005 FDA paper "Drug-Diagnostic Co-Development Concept Paper," and ownership and role of biomarkers.
• Benefi ts and incentives for stakeholders: detailed coverage of four incentive possibilities.
• Case study: Herceptin, HER-2 tests, and a pharmaceutical company executive' s perspective on the value of RxDx.
• Outlook: DxRx partnering challenges, parallel and nonparallel RxDx partnerships, and companies to watch.

Mentioned in This Spectrum Report

Companies

• Abbott
• Applera
• Arup Laboratories
• AstraZeneca
• Bayer
• BioGenex
• Biogen Idec
• Bristol-Myers Squibb
• Celera Genomics
• Chugai
• Clinical Data
• Dainippon Sumitomo
• Dako
• Elan
• Eli Lilly
• Genentech
• Genomic Health
• Genzyme
• Genzyme Genetics
• GlaxoSmithKline
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• Hoffmann-La Roche
• ImClone
• Johnson & Johnson
• MedImmune
• Merck KGaA
• Novartis
• Merck & Co.
• Perlegen
• Pfi zer
• PGx Health
• Prometheus Laboratories
• Riken
• Roche
• Schering AG
• Schering-Plough
• Serono
• Tanabe
• Ventana Medical Systems
• Vysis
• Wyeth
• Zenyaku

Table of Contents

• Executive Summary
• Strategic Considerations
• Stakeholder Implications
• RxDx Products: Balancing Public Benefit and Company Profit
• Key Codevelopment Concepts
• The FDA Concept Paper
• Draft Paper Addresses RxDx Codevelopment Timelines/Steps
• Clarifications Requested by Industry
• It' s All About the Biomarker
• Who Has the Biomarkers?
• When Is RxDx Development Necessary and When Is It Not?
• What' s in It for Me?
• Incentives to Codevelop an RxDx
• Decreasing Costs of RxDx Codevelopment
• Increasing Pricing/Reimbursement for RxDx Products
• Robbing Rx to Pay Dx
• Increasing Market and Patent Exclusivities
• Case Study: Herceptin, HER-2 Tests, and the Value of RxDx
• Cost-Effectiveness of Herceptin
• Cost-Effectiveness of HER-2 Tests
• Executive Perspective: Value of RxDx
• Detailed Analysis: Cost-Effectiveness of Herceptin
• Outlook
• RxDx Partnering Challenges
• Parallel and Nonparallel RxDx Partnerships
• "We Choose to Go to the Moon"
• Companies to Watch
• It Will Be Done in This Decade

Tables

• 1. Ranking of Monoclonal Antibodies by Indication and Worldwide Sales
• 2. Select Companion Diagnostic Tests

Figures

• 1. Biomarkers and Drug Development
• 2. RxDx Codevelopment Process
• 3. Chromosome 5: Distribution of Single Nucleotide Polymorphisms
• 4. Average Response Rates to "One-Size-Fits-All" Drugs
• 5. When to Develop Companion RxDx Products
• 6. Perception of Benefit by Different Stakeholders