Pipeline Insight: Parkinson's Disease and Restless Legs Syndrome - Reformulations Set To Drive Near-term Growth : Market Research Report

Pipeline Insight: Parkinson's Disease and Restless Legs Syndrome - Reformulations Set To Drive Near-term Growth

Published by: Datamonitor

Published: Aug. 11, 2006 - 308 Pages

ABOUT DATAMONITOR HEALTHCARE: About the CNS pharmaceutical analysis team
CHAPTER 1 EXECUTIVE SUMMARY: Scope of the analysis; Datamonitor insight into the Parkinson's disease and Restless Legs Syndrome market
CHAPTER 2 PATIENT POTENTIAL- PARKINSON'S DISEASE: Definition of Parkinson's disease; Segmentation of Parkinson's disease; Epidemiology of Parkinson's disease; New tools are improving diagnosis; Treatment strategies in Parkinson's disease; Unmet needs in Parkinson's disease
CHAPTER 3 PARKINSON'S DISEASE R&D APPROACH: Classification of marketed and pipeline products; Clinical trial design in Parkinson's disease; Clinical trial endpoints in Parkinson's disease; Gold standard therapies for Parkinson's disease
CHAPTER 4 PARKINSON'S DISEASE PIPELINE ANALYSIS: Pipeline overview; Late-stage pipeline overview; Key companies involved in the Parkinson's disease pipeline
CHAPTER 5 DOPAMINERGICS- LATE-STAGE DRUG ANALYSIS AND FORECASTS: Overview of the dopaminergic class; V1512 (melevodopa-carbidopa)
CHAPTER 6 DOPAMINE AGONISTS- LATE-STAGE DRUG ANALYSIS AND FORECASTS: Overview of the dopamine agonists class; Requip Modutab (ropinirole XL 24 hour); SLV-308; Other drugs in the dopamine agonist class
CHAPTER 7 ADENOSINE A2A RECEPTOR ANTAGONISTS- LATE-STAGE DRUG ANALYSIS AND FORECASTS: Overview of the adenosine A2a receptor antagonist class; KW-6002 (istradefylline); Other drugs in the adenosine A2a receptor antagonist class
CHAPTER 8 MAOIS- LATE-STAGE DRUG ANALYSIS AND FORECASTS: Overview of the MAOI class; Safinamide (NW-1015)
CHAPTER 9 NEUROPROTECTANTS- LATE STAGE DRUG ANALYSIS: Overview of the neuroprotectant class; SR57667; PD-02 (creatine); Cereact Capsule (ONO-2506PO); GM1 ganglioside; Kinampa (talampanel); FP-0011; Late-stage development compounds recently discontinued
CHAPTER 10 CELL/GENE THERAPY- LATE STAGE PRODUCT ANALYSIS: Overview of the cell/gene therapy class; Spheramine (RPE cell therapy); AV201 (AAV-AADC)
CHAPTER 11 OTHERS- LATE-STAGE DRUG ANALYSIS AND FORECASTS: Overview of the others class; E2007; Other drugs in the others class; Late-stage development compounds recently discontinued
CHAPTER 12 INNOVATIVE EARLY-STAGE PARKINSON'S DISEASE PROJECTS: Phase I and preclinical pipeline overview; Key Phase I and preclinical projects in PD
CHAPTER 13 PATIENT POTENTIAL- RESTLESS LEGS SYNDROME: Definition of Restless Legs Syndrome; Segmentation of Restless Legs Syndrome; Epidemiology of Restless Legs Syndrome; Treatment strategies in Restless Legs Syndrome; Unmet needs in Restless Legs Syndrome
CHAPTER 14 RESTLESS LEGS SYNDROME R&D APPROACH: Classification of marketed and pipeline products; Clinical trial design in Restless Legs Syndrome; GSK's Requip (ropinirole)-the gold standard Restless Legs Syndrome treatment; Strategies for success
CHAPTER 15 RESTLESS LEGS SYNDROME PIPELINE ANALYSIS: Overview of treatments in development for Restless Legs Syndrome; Requip XR (ropinirole extended release); Transdermal rotigotine patch; XP13512; Other drugs for Restless Legs Syndrome
BIBLIOGRAPHY: References; Websites
APPENDIX: Forecast revenues; Methodology; Report methodology; Contributing experts; About Datamonitor
List of Tables: Table 1: The five stages of PD according to the Hoehn & Yahr scale; Table 2: Prevalence of PD across the three major market regions, 2006; Table 3: Diagnosed PD population in the US, Japan, and M5EU by severity; Table 4: Key dopamine agonists; Table 5: Study design in the assessment of pramipexole in early PD; Table 6: Study design in the assessment of pramipexole in early PD; Table 7: Adverse events occurring in >5% of early PD patients on pramipexole as a monotherapy; Table 8: Study design for pramipexole in advanced PD with levodopa; Table 9: Key results from study of pramipexole vs. placebo in advanced PD with levodopa; Table 10: Adverse events occurring in >5% of advanced PD patients treated with pramipexole in addition to levodopa; Table 11: Number of adverse events occurring with Neupro vs. placebo; Table 12: Study design in the assessment of rotigotine CDS in early PD; Table 13: Key results from large scale studies of rotigotine CDS in treating patients with early PD; Table 14: Commonly occurring adverse events that were more frequent in those treated with rotigotine than placebo; Table 15: Results from the N. American study (SEESAW) of entacapone in patients experiencing ON and OFF periods despite optimized levodopa therapy; Table 16: Results from the Nordic study (NOMECOMT) of entacapone in patients experiencing ON and OFF periods despite optimized levodopa therapy; Table 17: Results from the German-Austrian study of entacapone in patients taking levodopa-DDI and experiencing 'wearing off'; Table 18: Adverse events occurring in ¡Ý5% of entacapone patients; Table 19: Pros and cons of neuroprotection study endpoints; Table 20: Possible criteria for agent selection for neuroprotection studies; Table 21: Comparison of convention trial design versus the futility trial design; Table 22: Unified Parkinson's Disease Rating Scale : cognition, behavior and mood; Table 23: Number of R&D projects in each class split by phase of development for PD, 2006; Table 24: Compounds in registration for PD, 2006; Table 25: Compounds in pre-registration for PD, 2006; Table 26: Compounds in Phase III development for PD, 2006; Table 27: Compounds in Phase II development for PD, 2006; Table 28: Pfizer's R&D pipeline for PD treatments, 2006; Table 29: Vernalis' R&D pipeline for PD treatments, 2006; Table 30: Key products in late-stage development for the dopaminergic class, 2006; Table 31: Phase II studies of V1512 conducted by Chiesi; Table 32: Phase III studies of V1512 conducted by Chiesi; Table 33: Impacting factors on the sales of V1512, 2006-15; Table 34: Key products in late-stage development for the dopamine agonist class, 2006; Table 35: Impacting factors on the sales of Requip Modutab, 2006-15; Table 36: Impacting factors on the sales of SLV-308, 2006-15; Table 37: Key products in late-stage development for the adenosine A2a receptor antagonist class, 2006; Table 38: Impacting factors on the sales of KW-6002, 2006-15; Table 39: Key products in late-stage development for the MAOI class, 2006; Table 40: Number of withdrawals and reasons given; Table 41: Impacting factors on the sales of safinamide, 2006-15; Table 42: Key products in late-stage development for the neuroprotectant class, 2006; Table 43: Patient characteristics at baseline; Table 44: Change in UPDRS score from baseline to 12 months or the need for symptomatic therapy (whichever first); Table 45: Discontinued projects in the neuroprotectant class, 2005-06; Table 46: Key products in late-stage development for the cell/gene therapy class, 2006; Table 47: Key products in late-stage development for the others class, 2006; Table 48: Impacting factors on the sales of E2007, 2006-15; Table 49: Discontinued R&D projects in the 'others' class, 2005-06; Table 50: Projects in Phase I development for PD, 2006; Table 51: Projects in preclinical development for PD, 2006; Table 52: Projects in preclinical development for PD, 2006 (continued); Table 53: Projects in preclinical development for PD, 2006 (continued); Table 54: The International Restless Legs Syndrome Study Group Rating Scale (IRLS); Table 55: The prevalence of RLS in the US, M5EU and Japan, 2006; Table 56: Dose titration schedule for ropinirole in treating RLS; Table 57: Trial end points used in pivotal studies of Requip for RLS; Table 58: TREAT RLS US study of ropinirole vs. placebo; Table 59: TREAT RLS 1 study of ropinirole vs. placebo conducted in the EU and other countries; Table 60: TREAT RLS 2 study of ropinirole vs. placebo conducted in the US and other countries; Table 61: Products in development for RLS, 2006; Table 62: Impacting factors on Requip XR RLS sales, 2006-15; Table 63: Impacting factors on transdermal rotigotine RLS sales, 2006-15; Table 64: Results of Phase IIb study; Table 65: Impacting factors on XP13512 RLS sales, 2006-15; Table 66: Forecast Parkinson disease drug revenues, 2006-2015; Table 67: Forecast Restless Legs Syndrome drug revenues, 2006-2015; Table 68: Parkinson's disease and Restless Legs Syndrome market definition by ICD10 code
List of Figures: Figure 1: Projection of the population aged 65 or greater, across the three major market regions, 2005-2050; Figure 2: Current treatment pathway of PD patients as recommended by guidelines; Figure 3: Recommendations for management of Parkinson's disease according to stage of disease; Figure 4: Key unmet needs in Parkinson's disease treatment; Figure 5: Unmet needs according to stage of disease; Figure 6: Levodopa dose required to relieve symptoms compared to dose required to induce dyskinesias; Figure 7: Mechanism of action of AADC inhibitors (DDI); Figure 8: Results from the long-term study of Requip vs. levodopa on the development of dyskinesia; Figure 9: Key results from six month trial of pramipexole monotherapy vs. placebo in treating patients with early PD; Figure 10: Key results from mixed-dose study of pramipexole monotherapy vs. placebo in treating patients with early PD; Figure 11: Key results from study of pramipexole vs. placebo in advanced PD with levodopa; Figure 12: Neupro patch sizes and corresponding doses; Figure 13: Change in UPDRS-II-III scores compared to placebo for groups taking 2 to 8mg/24hrrotigotine; Figure 14: UPDRS part II and III scores with Neupro vs. placebo; Figure 15: Study SP512 results- comparison of rotigotine vs. placebo in early PD over 24 weeks maintenance; Figure 16: Study SP513 results - comparison of rotigotine vs. ropinirole or placebo in early PD over 24 weeks maintenance; Figure 17: Pooled results from three-randomized controlled clinical trials evaluating efficacy of Apokyn; Figure 18: Mechanism of action of COMT inhibitor, entacapone; Figure 19: Key results from the N. American study (SEESAW) of entacapone in patients experiencing ON and OFF periods despite optimized levodopa therapy; Figure 20: Key results from the Nordic study (NOMECOMT) of entacapone in patients experiencing ON and OFF periods despite optimized levodopa therapy; Figure 21: Mechanism of action of MAO-B inhibitors; Figure 22: Mean daily percentage awake OFF time with Zelapar (1.25 and 2.5mg/day) against placebo; Figure 23: TEMPO study- change in UPDRS score with 1mg/day rasagiline vs. placebo over six months; Figure 24: TEMPO study- change in UPDRS score with rasagiline vs. placebo over 12 months; Figure 25: Change over 18 weeks in the LARGO study of rasagiline as an adjunct to treatment in patients with moderate-to-advanced PD; Figure 26: Change in daily ON time without troublesome dyskinesia over 18 weeks in the LARGO study of rasagiline as an adjunct to treatment in patients with moderate-to-advanced PD; Figure 27: Change in daily ON time with troublesome dyskinesia over 18 weeks in the LARGO study of rasagiline as an adjunct to treatment in patients with moderate-to-advanced PD; Figure 28: Change in daily OFF time over 26 weeks in the PRESTO study of rasagiline as an adjunct to treatment in moderate-to-advanced PD patients with motor complications; Figure 29: Recommendations for management of Parkinson's disease according to stage of disease; Figure 30: Number of R&D projects at each stage of development, 2006; Figure 31: Vernalis' inline and pipeline PD product range and where they fit into the PD disease stages, 2006; Figure 32: Depicts V1512's (CNP-1512) ability to reduce OFF time in Phase II/III studies of PD patients experiencing motor fluctuations; Figure 33: V1512's positioning against current unmet needs; Figure 34: Forecast Parkinson's disease sales for V1512 across the US and EU, 2006-2015; Figure 35: Requip Modutab's positioning against current unmet needs; Figure 36: Forecast Parkinson's disease sales for Requip Modutab across the US and EU, 2006-2015; Figure 37: Forecast Parkinson's disease sales for SLV-308 across the US and EU, 2006-2015; Figure 38: KW-6002's position against current unmet needs; Figure 39: Datamonitor's forecast of KW-6002's revenues across the US, EU and Japan ($m), 2006-2015; Figure 40: UPDRS-III scores over the Phase II trials of safinamide in a subset of patients also taking one dopamine agonist; Figure 41: Safinamide's position against current unmet needs; Figure 42: Datamonitor's forecast of safinamide's revenues across the US, EU and Japan ($m), 2006-2015; Figure 43: Participant flow in the Phase II study of PD-02 in early PD; Figure 44: E2007 proof-of-concept Phase II trial results; Figure 45: E2007's position against current unmet needs; Figure 46: Datamonitor's forecast of E2007's revenues across the US, EU and Japan ($m), 2006-2015; Figure 47: Phase II trial results of NS2330 in advanced PD; Figure 48: Results showing the effects of ProSavin in MPTP-treated primates; Figure 49: The proportion of individuals with RLS classified as having a medically significant diagnosis; Figure 50: The prevalence of RLS in the EU by age group; Figure 51: Key unmet needs in RLS treatment; Figure 52: Change in IRLS total score over 12 weeks (pooled results from the three pivotal studies used for US filing); Figure 53: Most common adverse events reported in patients treated with ropinirole in TREAT RLS trials; Figure 54: Unmet needs associated with Requip; Figure 55: Requip XR's potential advantages over current treatments; Figure 56: Forecast RLS sales for Requip XR across the US and EU, 2006-2015; Figure 57: Transdermal rotigotine's potential advantages over current treatments; Figure 58: Forecast RLS sales for transdermal rotigotine across the US and EU, 2006-2015; Figure 59: XP13512's potential advantages over current treatments; Figure 60: Forecast RLS sales for XP13512 across the US, EU and Japan 2006-2015

Abstract

Introduction

Despite affecting a large number of individuals, there are currently no treatments capable of curing either Parkinson's disease or Restless Legs Syndrome. Although available treatments are effective, numerous unmet needs prevail. Several compounds are in late-stage development and are forecast to achieve sales of $519m for Parkinson's disease and $399m for Restless Legs Syndrome in 2015.

Scope

Analysis of patient potential, unmet needs and clinical trial design in Parkinson's disease and Restless Legs Syndrome across the US, EU and Japan
Overview of drugs in pre-registration, Phase III, II, I and preclinical development; with analysis of key companies involved in the market
Detailed profiles of key compounds in development for Parkinson's disease and Restless Legs Syndrome, with forecasts of drug revenues to 2015
Discussion of innovative early stage products and insight from key industry opinion leaders

Highlights

Dopamine agonists with alternative delivery systems are expected to drive near-term changes in the Parkinson's disease market. While Schwarz's rotigotine patch holds several advantages over current oral treatments its success looks set to be eclipsed by GSK's once-daily tablet, Requip Modutab, which is forecast to reach peak sales of $543m in 2011.

The mid-stage pipeline for Parkinson's disease is unimpressive, with a host of potential neuroprotectants failing to demonstrate conclusive benefits in slowing disease progression. The most exciting near-term prospects are likely to come from cell and gene therapy products such as Titan/Schering's Spheramine or Avigen's AV-201.

The recent approval of the dopamine agonists Requip and Mirapex for Restless Legs Syndrome have provided a viable treatment option. However, unmet needs still exist and treatments, such as XenoPort's XP13512 which offer alternative mechanisms to dopaminergic stimulation may provide greater symptomatic benefit to current treatments.

Reasons to Purchase

Understand unmet needs in the Parkinson's disease and Restless Legs Syndrome market based on key opinion leader comments
Benchmark key late-stage Parkinson's disease and Restless Legs Syndrome compounds against current market leaders
Assess the global sales forecasts of late-stage pipeline drugs; and examine their clinical and commercial potential

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Pipeline Insight: Parkinson's Disease and Restless Legs Syndrome - Reformulations Set To Drive Near-term Growth

Table of Contents

Abstract