Albany, NY -- (SBWIRE) -- 12/13/2013 -- Parkinsons Disease Therapeutics Market to 2019 - Pipeline Shows Shift towards Long Term Disease Management

The pharma report - “Parkinson’s Disease Therapeutics Market to 2019 - Pipeline Shows Shift towards Long Term Disease Management”. The Parkinson’s Disease (PD) market is dominated by symptomatic treatments targeting functional impairment in PD. Levodopa has remained the gold standard treatment for almost 40 years and has significantly improved patient quality of life. There is currently there is a huge unmet need for disease-modifying treatments that slow progression or have neuroprotective properties. Over the 2012–2019 forecast period, the PD market is anticipated to decline from $3.4 billion in 2012 to $2.9 billion in 2019, as a consequence of upcoming patent expirations of high-profile products such as Azilect, Stalevo and Comtan. Although a few market entrants are anticipated to enter the market over the forecast period, they are not expected to offset the impact of generic erosion. Despite their superior profiles over existing treatments, these new products are not expected to command a premium price as they will be competing against generic products. The current PD pipeline reflects a shift of focus to long-term PD management, marked by the development of key pipeline candidates targeting levodopa-associated motor complications. These products will have the potential to change the future treatment algorithm as side effects of dopaminergic therapies become more manageable.

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Scope

- A brief introduction to PD, including pathogenesis, disease staging, diagnosis and treatment algorithms
- In-depth analysis of the drugs available for the treatment of PD, covering their safety, efficacy, treatment patterns, and strengths/weaknesses, as well as a heat map comparing drugs in terms of safety and efficacy
- Comprehensive review of the pipeline for PD therapies, including individual analysis of a number of late-stage pipeline drugs that are likely to enter the market in the forecast period, on the basis of phase distribution, molecule type and molecular target
- Additional in-depth analysis of pipeline drug clinical trials by Phase, molecule type, trial size, trial duration, and program failure rate analyses for each molecule type and mechanism of action
- Multi-scenario market forecast data to 2019, taking into account how it will be affected by the introduction of new drugs, the expiry of key patents on current drugs, and changes in disease epidemiology across the key developed markets of the US, Canada, Japan, Germany, the UK, France, Italy and Spain
- Discussion of the drivers of and barriers to market growth
- Discussion of the licensing and co-development deals landscape in PD, by stage of development, molecule type and mechanism of action, as well as analysis both licensing and co-development deals by year, and network maps of licensing and co-development deals

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Reasons to Buy

- Understand the different levels of PD therapy from early-stage to advanced
- Understand the vast scope of the pipeline, including which molecule types and mechanisms of action are prominent
- Observe the trends in clinical trial duration and size amongst clinical phases and molecule types, and use the clinical trial failure rate analysis to assess the risk profiles of current and/or future developmental programs for PD therapeutics
- Observe the trends in clinical trial duration and size amongst clinical Phases, between molecule types and mechanisms of action, and use the clinical trial failure rate analysis to assess the risk profiles of current and/or future developmental programs for PD therapeutics
- Assess the potential clinical and commercial impact of current late-stage pipeline molecules on the PD therapeutics market

Table of Contents

1 Table of Contents 1
1.1 List of Tables 3
1.2 List of Figures 4

2 Executive Summary 5
2.1 Impact of Patent Expiration Unlikely to Be Diminished by New Market Entrants 5
2.2 Shifting Focus of Pipeline to Long-Term Management of Parkinson’s Disease 5
2.3 High Number of Neuroprotective Targets in Early Pipeline 5

3 Introduction 6
3.1 Overview 6
3.2 Epidemiology 6
3.3 Etiology 7
3.3.1 Loss of Dopaminergic Neurons 7
3.3.2 Genetic Factors 7
3.3.3 Exposure to Environmental Toxins 7
3.4 Pathophysiology 8
3.4.1 Pathophysiological Changes in Basal Ganglia in Parkinson’s Disease 10
3.4.2 Pathophysiological Changes Involved in the Rise of Motor Complications in Parkinson’s Disease 10
3.5 Symptoms 11
3.6 Co-morbidities and Complications 12
3.7 Diagnosis 12
3.7.1 Classification 13
3.8 Prognosis and Disease Staging 16
3.9 Treatment Options 17
3.9.1 Pharmacological Treatment 17
3.9.2 Non-pharmacological Treatments 19
3.9.3 Treatment Algorithm 20
3.10 GBI Research Report Guidance 24

4 Marketed Products 25
4.1 Therapeutic Landscape 26
4.1.1 Dopamine Replacement Therapies 26
4.1.2 MAO-B inhibitors 30
4.1.3 Dopamine Agonists 32
4.1.4 COMT Inhibitors 42
4.1.5 Nouriast (istradefylline) – Kyowa Hakko Kirin 44
4.1.6 Exelon (rivastigmine tartrate) – Novartis AG 44
4.1.7 Symmetrel (amantadine hydrochloride) – Alliance Pharma Plc 46
4.1.8 Other drugs targeting non-motor symptoms of PD 47
4.2 Comparative Efficacy and Safety 48
4.3 Unmet Need 52

5 Pipeline for Parkinson’s Disease 53
5.1 Overall Pipeline 53
5.2 Molecular Targets in Parkinson’s Disease Pipeline 55
5.3 Clinical Trials 58
5.3.1 Failure Rate of Developmental Pipeline 58
5.3.2 Clinical Trial Sizes 61
5.3.3 Clinical Trial Duration 62
5.3.4 Summary of Clinical Trial Cost and Risk Analyses 64
5.4 Promising Candidates in Pipeline 65
5.4.1 Rytary (carbidopa, levodopa) – Impax Laboratories, Inc. 65
5.4.2 Safinamide – Newron Pharmaceuticals S.p.A 65
5.4.3 Pimavanserin – Acadia Pharmaceuticals Inc. 66
5.4.4 Tozadenant – Biotie Therapies 67
5.4.5 Mavoglurant – Novartis AG 67
5.4.6 Dipraglurant – Addex Therapeutics 68
5.5 Heat Map of Safety and Efficacy for Parkinson’s Disease Pipeline and Marketed Products 69

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6 Market Forecast to 2019 73
6.1 Geographical Markets 73
6.1.1 Global Market 74
6.1.2 North America 76
6.1.3 Top Five Countries of Europe 79
6.1.4 Japan 82
6.2 Drivers and Barriers 85
6.2.1 Drivers 85
6.2.2 Barriers 86

7 Deals and Strategic Consolidations 88
7.1 Major Co-development Deals 88
7.1.1 Newron Pharmaceuticals S.p.A. Enter Agreement with Zambon Company S.p.A. 91
7.1.2 QR Pharma, Inc. Enter Research Agreement with Massachusetts General Hospital 91
7.1.3 Ceregene, Inc. Enter Agreement with Genzyme Corporation 91
7.2 Major Licensing Deals 91
7.2.1 Biotie Therapies Corp. Enter Worldwide Agreement with UCB Group 94
7.2.2 Ono Pharmaceutical Co., Ltd. Enter Agreement with Bial - Portela & Ca, S.A 94
7.2.3 Domain Therapeutics S.A. Enter Agreement with Prexton Therapeutics 95
7.2.4 Newron Pharmaceuticals S.p.A. Enter Agreement with Zambon Company S.p.A. 95
7.2.5 Oncodesign SA Enter Agreement with Ipsen S.A. 95
7.2.6 Cephalon, Inc. Enter Licensing Agreement with Mesoblast Limited 95
7.2.7 Shire Pharmaceutical Group Plc Enter Agreement with Heptares Therapeutics Ltd. 96

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