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[Report]

Pipeline Insight: Parkinson's Disease and Restless Legs Syndrome - Reformulations set to drive near-term growth

Published: 2006/08

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Description

Table of Contents

  • 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
      • The etiology of PD is not yet clear
    • Segmentation of Parkinson's disease
      • Parkinson's disease is typically classified by the Hoehn & Yahr scale
    • Epidemiology of Parkinson's disease
      • Demographics provide baseline sales growth
      • Several comorbid disorders are thought to result from neurodegeneration in PD
        • Sleep disorders are most common in advanced PD
        • Depression in PD has both psychological and pathological causes
        • Dementia in PD becomes more likely as the disease progresses
        • Psychosis is both a feature of PD and a side effect of treatment
    • New tools are improving diagnosis
    • Treatment strategies in Parkinson's disease
    • Unmet needs in Parkinson's disease
      • Drugs that slow or prevent disease progression
      • Reduction of motor complications
        • Motor fluctuations
        • Dyskinesias
        • Other motor complications
      • Smoother levodopa dosage
      • Lower side effects
      • Reduce pill burden
      • Reduce time to levodopa therapy
      • Lower cost
  • CHAPTER 3 PARKINSON'S DISEASE R&D APPROACH
    • Classification of marketed and pipeline products
      • Market definition for this report
      • Dopaminergics
        • Levodopa still considered most effective agent for reducing PD symptoms
      • Dopamine agonists
        • Dopamine agonists considered first line therapy
        • Mirapex (pramipexole) the market leading dopamine agonist
        • Neupro (rotigotine CDS) offers an alternative delivery method
        • Apokyn (apomorphine) helps niche patient cohort
        • Several dopamine agonists with novel delivery systems are in development
      • Catechol-O-methyltransferase inhibitors
        • Comtan (entacapone) is the market leading COMT-inhibitor
        • Stalevo reduces pill burden
      • Monoamine oxidase inhibitors
        • Selegiline has an established role in the treatment of early PD
        • Zelapar (selegiline; orally disintegrating tablets) may offer advantages over conventional selegiline
        • Azilect (rasagiline) has recently received approval for early and late stage PD
        • Safinamide is the only MAOI in late stage development
      • Other marketed therapies
        • Anticholinergics provide little interest for developers of new treatments
        • N-methlyl-D-aspartate receptor antagonists may hold further potential
      • Novel therapies
        • The potential for adenosine A2a receptor antagonists remains unclear
        • Neuroprotectants aim to slow or stop the progression of PD
        • Cell/ gene therapies are designed to make up for the loss of neurons in PD
    • Clinical trial design in Parkinson's disease
      • Neuroprotection clinical trial design continues to present challenges
        • At risk patients are ideal for studies but are difficult to recruit
        • Choice of clinical endpoints in neuroprotective studies depends on the population studied
        • Futility studies help determine which agents to select for further study
        • Delayed start design aims to separate symptomatic from neuroprotective effect of a study agent
    • Clinical trial endpoints in Parkinson's disease
      • Decreased latency to ON time, increased ON time, and decreased OFF time are key endpoints for EU and US approval
      • Unified Parkinson's Disease Rating Scale offers a more comprehensive measure of PD progression
        • Cognition, behavior and mood- Part I of the UPDRS
        • Activities of daily living- Part II of the UPDRS
        • Motor examination- Part III of the UPDRS
    • Gold standard therapies for Parkinson's disease
  • CHAPTER 4 PARKINSON'S DISEASE PIPELINE ANALYSIS
    • Pipeline overview
    • Late-stage pipeline overview
      • Registration overview
      • Pre-registration overview
      • Phase III overview
      • Phase II overview
    • Key companies involved in the Parkinson's disease pipeline
      • Big Pharma need to increase investment into drug discovery projects for disease modifying agents
        • Pfizer
      • The symptomatic treatment market provides opportunities for specialty companies
        • Vernalis
  • CHAPTER 5 DOPAMINERGICS- LATE-STAGE DRUG ANALYSIS AND FORECASTS
    • Overview of the dopaminergic class
      • Pipeline summary
    • V1512 (melevodopa-carbidopa)
      • Drug overview
      • Clinical trials
        • Phase II/III trials conducted by Chiesi
        • Ongoing Phase III trials
        • Pharmacokinetic study
      • Patient potential
      • Marketing factors
      • Further Datamonitor comments
      • Satisfaction of unmet needs
        • Reduction of dyskinesia or OFF time
        • Smoother levodopa dosage
        • Reduce pill burden
        • Lower cost
      • Forecasts to 2015
        • Datamonitor does not expect V1512 to gain significant sales from current treatments
        • V1512 is at risk of generic entacapone from 2010
  • CHAPTER 6 DOPAMINE AGONISTS- LATE-STAGE DRUG ANALYSIS AND FORECASTS
    • Overview of the dopamine agonists class
      • Pipeline summary
    • Requip Modutab (ropinirole XL 24 hour)
      • Clinical trials
        • Ongoing Phase III comparison with immediate release ropinirole
      • Patient population
      • Marketing factors
      • Satisfaction of unmet needs
        • Reduction of dyskinesia or OFF time
        • Lower side effects
        • Reduce pill burden
        • Reduce time to levodopa therapy
        • Lower cost
      • Forecasts to 2015
        • Datamonitor expects Requip Modutab to limit the success of Neupro
        • Generic ropinirole is set to limit the success of Requip Modutab
    • SLV-308
      • Drug overview
      • Ongoing Phase III clinical trials
        • S308.3.001/ S308.3.003- SLV-308 in treatment of patients with early PD
        • Ascending dose tolerability/ safety study in advanced PD with levodopa
      • Patient potential
      • Marketing factors
      • Datamonitor comments
      • Forecasts to 2015
        • The role of SLV308 is not yet clear and forecast sales are low
    • Other drugs in the dopamine agonist class
      • Lisuride (TTS/ SubQ)
        • Lisuride TTS
        • Lisuride (SubQ)
        • Datamonitor comments
      • Rotigotine nasal spray
      • Apomorphine nasal powder
      • AMR-101 (apomorphine sublingual)
  • CHAPTER 7 ADENOSINE A2A RECEPTOR ANTAGONISTS- LATE-STAGE DRUG ANALYSIS AND FORECASTS
    • Overview of the adenosine A2a receptor antagonist class
      • Pipeline summary
    • KW-6002 (istradefylline)
      • Drug overview
      • Completed Phase III trials
        • Study 6002-US-018- 10, 20, 40mg/day KW-6002 in combination
        • Study 6002-US-013- 20mg/day KW-6002 in combination
        • Study 6002-EU-007- 40mg/day KW-6002 in combination
      • Completed Phase II trials
        • Study 6002-US-001- 20, 40mg/day KW-6002 in combination
      • Ongoing trials
        • Study 6002-US-051- Phase II monotherapy in early PD
        • Study 6002-0406- Phase II Japan- 20, 40mg/day KW-6002 in combination
        • Study 6002-0407- Phase II Japan- early PD
        • Study 6002-INT-001- long-term safety
        • Study 6002-US-025- long-term safety
      • Patient population
      • Marketing factors
      • Further Datamonitor comments
      • Satisfaction of unmet needs
        • Reduction of dyskinesia or OFF time
        • Lower side effects
        • Reduce pill burden
        • Reduce time to levodopa therapy
        • Lower cost
      • Forecasts to 2015
        • KW-6002 may provide a novel mechanism for treating 'wearing off'
        • KW-6002 sales are expected to depend on the success of E2007
        • Approval in Japan and use in early PD may support sales growth
    • Other drugs in the adenosine A2a receptor antagonist class
      • Fipamezole (JP-1730)
        • Clinical trials
      • Sch-58261 analog
  • CHAPTER 8 MAOIS- LATE-STAGE DRUG ANALYSIS AND FORECASTS
    • Overview of the MAOI class
      • Pipeline summary
    • Safinamide (NW-1015)
      • Drug overview
      • Phase III clinical trials
        • Adjunctive treatment to dopamine agonists in patients with early-stage PD.
      • Phase II trials
        • Safinamide as an adjunct to a dopamine agonist in early PD.
      • Phase I trials
      • Patient potential
      • Marketing factors
      • Datamonitor comments
      • Satisfaction of unmet needs
        • Drugs that slow or prevent disease progression
        • Reduction of dyskinesia or OFF time
        • Reduce pill burden
        • Lower cost
      • Forecasts to 2015
        • Safinamide's benefits over current MAOIs are unclear
        • The ADAGIO study of Azilect will set the first hurdle for safinamide in neuroprotection
  • CHAPTER 9 NEUROPROTECTANTS- LATE STAGE DRUG ANALYSIS
    • Overview of the neuroprotectant class
      • Pipeline summary
      • Definition of current comparator therapy
    • SR57667
      • Ongoing clinical trials
        • EFC5287- Phase II study of SR57667 on the progression of PD
        • ACT5288- Study of SR57667 on 18F-Dopa PET imaging in PD patients
      • Further Datamonitor comments
    • PD-02 (creatine)
      • Phase II clinical trials
        • Phase II futility study of PD-02 in early PD
    • Cereact Capsule (ONO-2506PO)
      • Drug overview
      • Clinical trials
        • Phase II study of ONO-2506PO in patients with PD in Japan.
      • Datamonitor comments
    • GM1 ganglioside
      • Drug overview
      • Clinical trials
        • Phase II study of GM1 ganglioside in mild to moderate PD
        • Second Phase II study of GM1 ganglioside in mild to moderate PD
    • Kinampa (talampanel)
      • Drug overview
      • Clinical trials
        • Phase II study of talampanel on dyskinesias associated with treatment of patients with advanced PD
        • NINDS sponsored Phase II study of talampanel
    • FP-0011
    • Late-stage development compounds recently discontinued
      • GPI-1485
        • Phase II study- Guildford Pharmaceuticals/ Amgen
        • Phase II study- Guildford/ SNDC
        • Phase II study- NINDS
  • CHAPTER 10 CELL/GENE THERAPY- LATE STAGE PRODUCT ANALYSIS
    • Overview of the cell/gene therapy class
      • Pipeline summary
      • Definition of current comparator therapy
    • Spheramine (RPE cell therapy)
      • Drug overview
      • Clinical trials
        • Phase I/II open-label study
        • The STEPS trial- Phase II double-blind study
      • Further Datamonitor comments
    • AV201 (AAV-AADC)
      • Drug overview
      • Clinical trials
        • Phase I/II increasing dose trial
  • CHAPTER 11 OTHERS- LATE-STAGE DRUG ANALYSIS AND FORECASTS
    • Overview of the others class
      • Pipeline summary
    • E2007
      • Drug overview
      • Completed Phase II trials
        • Study 204- Phase IIb proof-of-concept
      • Ongoing Phase III trials
        • Study E2007-E044-301- E2007 in levodopa treated PD patients with motor fluctuations
      • Patient potential
      • Marketing factors
      • Further Datamonitor comments
      • Satisfaction of unmet needs
        • Reduction of dyskinesia or OFF time
        • Lower side effects
        • Lower cost
      • Forecasts to 2015
        • E2007 is positioned as an alternative treatment for reducing OFF time
    • Other drugs in the others class
      • Tremode (zonisamide)
        • Drug overview
        • Clinical trials
        • Forecast
      • Keppra (levetiracetam)
        • Clinical trials
      • ACP-103
        • Phase II study of ACP-103 on levodopa-induced dykinesias in PD
    • Late-stage development compounds recently discontinued
      • Sarizotan (EMD-128130)
        • Drug overview
        • Clinical trials
        • Further Datamonitor comments
      • Tesofensine (NS2330)
        • Drug overview
        • Clinical trials
        • Datamonitor comments
  • CHAPTER 12 INNOVATIVE EARLY-STAGE PARKINSON'S DISEASE PROJECTS
    • Phase I and preclinical pipeline overview
      • Phase I overview
      • Preclinical overview
    • Key Phase I and preclinical projects in PD
      • Prosavin
      • Alpha (α)-synuclein modulation
  • CHAPTER 13 PATIENT POTENTIAL- RESTLESS LEGS SYNDROME
    • Definition of Restless Legs Syndrome
      • Etiology
      • Diagnosis
    • Segmentation of Restless Legs Syndrome
      • Severity
        • International Restless Legs Syndrome Study Group Rating Scale (IRLS).
      • Comorbidities
    • Epidemiology of Restless Legs Syndrome
      • Prevalence
    • Treatment strategies in Restless Legs Syndrome
    • Unmet needs in Restless Legs Syndrome
      • Greater efficacy
      • Faster onset of action
      • Longer duration of action
      • Improved side effect profile
      • Effective second-line treatment
      • Reduced frequency of dosing
  • CHAPTER 14 RESTLESS LEGS SYNDROME R&D APPROACH
    • Classification of marketed and pipeline products
      • Market definition of Restless Legs Syndrome for this report
      • Dopaminergic stimulation provides the mainstay of RLS treatment
        • Dopamine agonists are the first-line choice
        • Levodopa use is limited by the risk of augmentation
      • Anticonvulsants are typically used in treatment resistant RLS
      • Opioids can be useful for treatment resistant, painful RLS
      • Sedatives may alleviate sleep disturbance
      • Iron infusion poses a potential risk to RLS revenues
    • Clinical trial design in Restless Legs Syndrome
      • The IRLS is considered an essential primary efficacy measure
        • Clinical Global Impression (CGI)
        • Quality of life (QOL) measures
        • Sleep disturbance
        • Cardiovascular risks
    • GSK's Requip (ropinirole)-the gold standard Restless Legs Syndrome treatment
      • Drug overview
      • Completed Phase III trials
        • Study design
        • Results
        • Long-term maintenance of efficacy
      • Ongoing trials
        • Study ROR104836
        • TREAT RLS PRN
      • Further Datamonitor comments
    • Strategies for success
  • CHAPTER 15 RESTLESS LEGS SYNDROME PIPELINE ANALYSIS
    • Overview of treatments in development for Restless Legs Syndrome
      • Pipeline summary
    • Requip XR (ropinirole extended release)
      • Drug overview
      • Phase III clinical trials
        • US/EU Phase III study of Requip vs. Requip XR- 101468/204
        • N. American Phase III study- 101468/205
        • The ROX104805 Phase III study
      • Patient potential
      • Marketing factors
      • Satisfaction of unmet needs
        • Longer duration of action
        • Onset of action
      • Forecasts to 2015
        • Requip XR is expected to be eclipsed by Neupro
        • Generic ropinirole is set to limit Requip XR revenues
    • Transdermal rotigotine patch
      • Drug overview
      • Completed trials
        • SP709- Phase II EU proof-of-concept study
        • Open-label EU extension study
      • Ongoing trials
        • SP792- Phase III US study
        • SP793- Open-label extension to SP792
        • SP790- Phase III EU study
        • SP794- EU sleep lab trial
      • Patient potential
      • Marketing factors
      • Further Datamonitor comments
      • Satisfaction of unmet needs
        • Longer duration of action
        • Faster onset of action
        • Greater efficacy
      • Forecasts to 2015
        • Disadvantages associated with a patch formulation may limit sales
    • XP13512
      • Completed trials
        • Phase IIa
        • Phase IIb
      • Ongoing trials
        • XP052- US Phase III study
        • XP053- US Phase III study
        • XP060- US long-term withdrawal study
        • XP055- US open-label extension study
      • Patient potential
      • Marketing factors
      • Satisfaction of unmet needs
        • Greater efficacy
        • Faster onset of action
        • Duration of action
        • Effective second-line treatment
        • Improved side effect profile
      • Forecasts to 2015
        • XP13512 is expected to be positioned as an alternative to dopamine agonists
    • Other drugs for Restless Legs Syndrome
      • Lisuride TTS
      • KW-6002 (istradefylline)
      • Safinamide
      • Keppra (levetiracetam)
      • Topamax (topiramate)
  • BIBLIOGRAPHY
    • References
    • Websites
  • APPENDIX
    • Forecast revenues
    • Methodology
      • Datamonitor forecast methodology
        • Product forecasts
        • Sales calculations
        • Definition of a standard unit
        • Japanese market data
        • Additional assumptions
    • Report methodology
    • Contributing experts
    • About Datamonitor
      • About Datamonitor Healthcare
      • About the CNS analysis team
      • Disclaimer
    • 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 ≥5% 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
Description

[Report]
Pipeline Insight: Parkinson's Disease and Restless Legs Syndrome - Reformulations set to drive near-term growth
Published: 2006/08
Published by : Datamonitor Datamonitor

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