Parkinson's Disease Biomarkers: Vital Tools for Neuroprotectants
Decision Resources, Inc, November 2006, Pages: 32
Parkinson’s disease (PD) is poised to become a significant 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 significant 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 difficulties 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 benefit 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: benefits 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.
Author: Andrea S. Witt, Ph.D.
Decision Resources, Inc
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
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
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
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