Tuesday, February 9th, 2016

Frontier Pharma: Parkinson’s Disease - Identifying and Commercializing First-in-Class Innovation

Frontier Pharma: Parkinson’s Disease - Identifying and Commercializing First-in-Class Innovation


Parkinson’s Disease (PD) is the second most common neurodegenerative disease after Alzheimer’s disease, affecting around 7.4 million people worldwide. It is caused by the progressive loss of dopamine-producing neurons in the substantia nigra within the basal ganglia. The main motor symptoms are tremors, bradykinesia and rigidity, although symptoms vary between individuals. As the disease progresses to more advanced stages, increasing symptoms and complications develop, which can cause severe disability in patients.

The current market offers a number of anti-PD treatment options which provide symptomatic relief. Levodopa is currently the gold standard therapy, with other drug classes including dopamine agonists and Monoamine Oxidase B (MAO-B) inhibitors also used to treat early and advanced cases. With no current treatment showing effectiveness in delaying the course of the disease, PD remains incurable. The high unmet need for a disease-modifying therapy is reflected in the pipeline, where a high proportion of early-stage first-in-class programs target the potential pathogenic mechanisms underlying neurodegeneration.

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PD is a crowded market with many neuromodulatory drug classes available. However, a disease-modifying therapy with neuroprotective effects is yet to be developed. 
- What are the primary mechanisms that are thought to contribute to neuronal death? 
- What are the major barriers facing the development of investigational neuroprotective candidates? 
Analysis reveals a high level of innovation and diversity in the pipeline, with 121 first-in-class programs acting on 57 unique molecular targets. 
Neuromodulatory targets remain the dominant target family, particularly in the late-stage pipeline. 
- What are the first-in-class families with a significant presence? 
- How well do they align with the underlying pathways governing neuronal death in PD? 
Some of the first-in-class targets have a potentially stronger chance of being translated into novel treatments for PD. 
- What is the scientific rationale behind these targets? How do they perform in Preclinical studies? 
- What are the commonly used disease models and the parameters measuring neuroprotective effects in PD animal studies? 
Deals involving first-in-class PD products are more likely to be made in earlier stages of development than non-first-in-class deals. 
- What is the dominant molecular target in the PD deals landscape? 
- What are the promising first-in-class products still available for future licensing?

Reasons to buy

This report will allow you to - 
- Understand the current clinical and commercial landscape by considering the proposed pathogenic processes underlying PD neurodegeneration, diagnosis, prognosis, and the available treatment options and their usage in early and advanced PD. 
- Visualize the composition of the PD market to highlight the current unmet needs in order to gain a competitive understanding of the key opportunities. 
- Analyze the PD pipeline and stratify by stage of development, molecule type, and molecular target - the diversity of molecular targets in the pipeline is extremely encouraging due to the multifaceted nature of PD. 
- Assess the therapeutic potential of first-in-class targets using a proprietary matrix that assesses and ranks first-in-class products according to clinical potential. 
- Target the most promising and innovative PD products for early-stage investment by analyzing trends in licensing and co-development deals and accessing a curated list of first-in-class therapies potentially open to deal-making opportunities.

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Table Of Content

1.1 List of Tables 3 
    1.2 List of Figures 3 
2 Executive Summary 4 
    2.1 High Unmet Needs Remain in Parkinson’s Disease Market 4 
    2.2 Diverse and Innovative Pipeline to Shift Focus to Disease Modification 4 
    2.3 Deals Landscape Presents Substantial Investment Opportunities 4 
3 The Case for Innovation 5 
    3.1 Growing Opportunities for Biologic Products 6 
    3.2 Diversification of Molecular Targets 6 
    3.3 Innovative First-in-Class Product Developments Remain Attractive 6 
    3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 7 
    3.5 Sustained Innovation 7 
    3.6 GBI Research Report Guidance 8 
4 Clinical and Commercial Landscape 9 
    4.1 Disease Overview 9 
    4.2 Epidemiology 9 
    4.3 Disease Etiology 10 
      4.3.1 Exposure to Environmental Toxins 10 
      4.3.2 Genetic Causes of Familial Parkinson’s Disease 10 
      4.3.3 Susceptibility Genes for Parkinson’s Disease 12 
    4.4 Disease Pathophysiology 12 
      4.4.1 Basal Ganglia Anatomy and Physiology 12 
      4.4.2 Process Underlying Neurodegeneration 15 
    4.5 Disease Symptoms 19 
    4.6 Co-morbidities and Complications 19 
    4.7 Diagnosis 19 
    4.8 Classification of Disease Stages 20 
      4.8.1 Hoehn and Yahr Scale 20 
      4.8.2 Unified Parkinson’s Disease Rating Scale 20 
      4.8.3 Scale for the Assessment of Positive Symptoms 22 
      4.8.4 Mini Mental State Examination 22 
    4.9 Prognosis and Disease Staging 22 
    4.10 Treatment Options 23 
      4.10.1 Pharmacotherapy 23 
      4.10.2 Non-pharmacological Treatment 25 
    4.11 Overview of Marketed Products 25 
      4.11.1 Molecule Type and Target Analysis 26 
      4.11.2 Treatment Algorithm 27 
    4.12 Current Unmet Needs 33                

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