帕金森氏症的生物標記：為了神經保護藥的重要工具

本報告已在2011年12月21日停止出版。

簡介

目錄

Abstract

Introduction

Parkinson' s disease (PD) is poised to become a signifi cant public health burden as the population ages. We expect the number of PD cases in the seven major drug markets we cover to reach nearly 3.6 million in 2015, yet no therapy is available to treat the disease. Thus, the PD market provides signifi cant opportunity for disease-modifying drugs, but their potential will not be fully realized without a biomarker that permits diagnosis of the disease in its early stages, when disease-modifying therapies would be most effective

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By the time symptoms progress to the point where a physician diagnoses PD, up to 70-80% of dopaminergic neurons are lost. A biomarker would allow a PD patient to receive a diagnosis and start treatment years earlier. What are the diffi culties in diagnosing PD, and why are early diagnosis and treatment so important? What are the limitations of current treatments for PD? Several manufacturers are investigating imaging and genetic markers as diagnostic agents. What value does a PD biomarker offer? What diagnostic markers are emerging, and what challenges do they face? How might these agents impact the U.S. PD market? Disease-modifying (neuroprotectant) drugs can slow the progression of PD, but only two such drugs are expected to launch over the next ten years. The success of these drugs hinges on the development of a diagnostic marker. How are biomarkers impacting the development of neuroprotectants? Which drug manufacturers would benefi t most from the launch of a biomarker?

Scope

• Pathophysiology of Parkinson' s disease (PD): etiology and clinical symptoms, use of biomarkers.
• Value of biomarkers for PD: benefi ts and limitations of biomarkers and their effects on current and emerging PD therapies.
• Emerging imaging agents for PD diagnosis: DaTSCAN, Altropane, Dopascan.
• Market implications: concurrent drug/diagnostic development, hurdles to market, and the impact of PD biomarkers on neuroprotectant development.
• Outlook: how biomarkers will increase the potential of the PD market.

Mentioned in This Spectrum Report-Companies

• Aguettant
• Boehringer Ingelheim
• Boston Life Sciences
• Bristol-Myers Squibb
• Britannia Pharmaceuticals
• Cephalon
• Chiesi
• Daiichi Radioisotope Laboratories
• GE Healthcare
• GlaxoSmithKline
• Guilford Pharmaceuticals
• Lundbeck
• MAP Medical Technologies
• MGI Pharmaceuticals
• Molecular Neuroimaging
• Nycomed Amersham
• Orion
• PETNET Solutions
• Sanofi -Aventis
• Schering AG
• Somerset
• Symphony Neuro Development
• Company
• Teva Pharmaceuticals
• Titan Pharmaceuticals
• Vernalis

Table of Contents

• Executive Summary
• Strategic Considerations
• Stakeholder Implications
• Introduction
• Shortcomings of Current Diagnosis
• Potential Role of Biomarkers
• The Pathophysiology of Parkinson' s Disease
• Background
• PD Pathophysiology and Use of Biomarkers
• The Value of a Biomarker for PD
• Pitfalls Facing Biochemical/Genetic Markers
• Biochemical Markers
• Genetic Markers
• Emerging Imaging Agents for PD Diagnosis
• GE Healthcare' s DaTSCAN
• Boston Life Sciences' Altropane
• MGI Pharmaceuticals' Dopascan
• Market Implications
• Concurrent Drug/Diagnostic Development: PD as a Blueprint for Neurological Indications
• Hurdles to Market
• Impact of PD Biomarkers on Neuroprotectant Development
• Outlook
• Bibliography

Tables

• 1. Parkinson' s Disease and Other Parkinsonian Disorders
• 2. Select Diagnostic Imaging Agents in Development, 2006
• 3. Strengths and Weaknesses of Current and Emerging Parkinson' s Disease Biomarkers
• 4. Select Biochemical and Genetic Biomarker Candidates in Parkinson' s Disease, 2006
• 5. Number of Total Prevalent Cases of Parkinson' s Disease in the Major Pharmaceutical Markets, 2005-2015
• 6. Development Status and Concurrent Drug Programs for Select Parkinson' s Disease Imaging Agents 2
• 7. Lundbeck/Teva' s Rasagiline: A Fact Sheet

Figures

• 1. Braak Staging of Parkinson' s Disease
• 2. Rate of Dopaminergic Neuron Loss over the Course of Parkinson' s Disease
• 3. Brain Structures Implicated in Movement and Parkinson' s Disease
• 4. Proposed Deficits in the Basal Ganglia Thalamocortical Circuit of Parkinson' s Disease Patients
• 5. SPECT Imaging Agent Targets at the Dopaminergic Synapse

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