Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- About the Central Nervous System pharmaceutical analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the analysis
- Contributing experts
- Datamonitor insight into the Parkinson' s disease market
- Related reports
- Upcoming related reports
- CHAPTER 2 MARKET OVERVIEW AND POTENTIAL
- Market and disease definition
- Parkinson' s disease overview
- Definition of Parkinson' s disease market
- Market potential
- Epidemiology of PD
- Prevalence of PD
- Aging population provides baseline growth potential for PD
- Unmet need in PD
- Disease modifying treatments
- Reduction of motor complications
- Reduction in side effects
- Reduced pill burden
- Extended time to levodopa therapy
- Current treatment classes and mechanisms
- Treatment algorithm
- Dopaminergics
- Carbidopa adjunctive therapy
- Dopamine agonists
- Dopamine agonists move from adjunctive add-on to first-line therapy
- Catechol-O-methyltransferase inhibitors
- Monoamine oxidase inhibitors
- Other treatments
- Anticholinergics
- NMDA receptor antagonist - amantadine
- Market overview
- PD market has grown over the last four years
- The 5EU region generated more revenue from PD therapies than the US
- PD market is set to grow throughout the forecast period
- CHAPTER 3 BRAND DYNAMICS AND LEADING COMPARATOR THERAPIES
- Marketed brands overview
- Mirapex (pramipexole)
- Drug overview-market-leading dopamine agonist
- Forecast
- Clinical trial data
- Pramipexole provides benefits over placebo in the treatment of early
PD
- Pramipexole also provides benefits over placebo as an adjunct to
levodopa therapy in advanced PD
- Neupro (rotigotine CDS)
- Drug overview-moderate uptake of patch formulation dopamine agonist in
the 5EU
- Forecast
- Clinical trial data
- Dose-finding study SP 506 shows clear dose-dependent effect
- Early PD-study SP512 and SP513
- Phase III trials in advanced PD patients showed rotigotine to be
safe and effective as adjunct to levodopa
- Comtan (entacapone)
- Drug overview-adjunctive therapy to levodopa
- Forecast
- Clinical trial data
- Study 1-North America study (SEESAW) of entacapone in patients
taking levodopa-carbidopa
- Study 2-Nordic study (NOMECOMT) of entacapone in patients taking
levodopa-carbidopa
- Study 3-German-Austrian study of entacapone in patients taking
levodopa-carbidopa
- Stalevo
- Drug overview - combination of entacapone, carbidopa and levodopa
- Forecast
- Selegiline and its many reformulations
- Drug overview-highly genericized molecule
- Azilect (rasagiline)
- Drug overview-has recently received approval for early- and late-stage
PD
- Forecast
- Clinical trial data
- TEMPO study-rasagiline as a monotherapy in early PD
- TEMPO study-12 months open-label follow-up
- LARGO study-rasagiline as an adjunctive treatment in
moderate-to-advanced PD
- PRESTO study-adjunctive treatment in moderate-to-advanced PD
patients with motor complications
- Ongoing trial-ADAGIO disease progression
- CHAPTER 4 FORECAST ANALYSIS
- Key events
- New product launches
- Requip Modutab extended release
- Istradefylline (KW-6002)
- E2007
- SLV-308
- Safinamide
- V1512
- Pimavanserin (ACP-103)
- Product launches in Japan
- Comtan (entacapone)
- Neupro (rotigotine)
- Istradefylline (KW-6002)
- Additional indications
- Neupro indication for late-stage PD
- Patent expiries
- Requip (ropinirole)
- Mirapex (pramipexole)
- Comtan (entacapone)
- Azilect
- Data definitions, limitations and assumptions
- Standard Units
- Japanese market data
- Derivation of sales forecasts and pricing trends
- Forecast methodology
- CHAPTER 5 PIPELINE OVERVIEW - R&D DYNAMICS AND APPROACH
- Pipeline overview
- Classification of pipeline products
- Dopaminergics
- Dopamine agonists
- Catechol-O-methyltransferase inhibitors
- Monoamine oxidase inhibitors
- A2a receptor antagonists
- Drugs with neuroprotective potential
- Modulation of the glutaminergic pathway is a promising
neuroprotective strategy
- Other neuroprotective strategies in the current pipeline
- Other drug classes in the current pipeline
- Clinical trial design in PD
- Clinical trial endpoints in PD
- Decreased cumulative OFF time is the key to approval
- Unified PD Rating Scale
- 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
- The Hoehn and Yahr staging is widely used in clinical trials
- CHAPTER 6 LATE-STAGE DRUG ANALYSIS & FORECASTS
- Late-stage pipeline overview
- Dopaminergic class pipeline drugs
- Pipeline summary
- V1512 (melevodopa-carbidopa)
- Drug overview: Levodopa methyl ester and carbidopa
- Forecasts to 2016
- Marketing factors
- Patient potential
- Satisfaction of unmet needs
- Clinical trials
- Dopamine agonist class pipeline drugs
- Pipeline summary
- Requip Modutab/XL 24-hour
- Drug overview: extended release version of Requip
- Forecasts to 2016
- Marketing factors
- Patient potential
- Satisfaction of unmet needs
- Clinical trial data
- Ongoing clinical trials
- SLV-308
- Drug overview
- Forecasts to 2016
- Marketing factors
- Patient potential
- Satisfaction of unmet needs
- Clinical trial data
- Ongoing trials
- Other drugs in the dopamine agonist class
- Lisuride (TTS/Sub Q)
- Rotigotine nasal spray
- Apomorphine nasal powder
- Apomorphine Aspirair inhaler
- Catechol-O-methyltransferase inhibitors
- Pipeline summary
- BIA-3-202
- MAOI class pipeline drugs
- Pipeline summary
- Safinamide (NW-1015)
- Drug overview
- Forecasts to 2016
- Marketing factors
- Patient potential
- Satisfaction of unmet needs
- Clinical trials data
- Adenosine A2A receptor antagonist class pipeline drugs
- Pipeline summary
- Istradefylline (KW-6002)
- Drug overview-novel mechanism of action
- Forecasts to 2016
- Marketing factors
- Patient potential
- Satisfaction of unmet needs
- Clinical trial data
- Further studies
- Other drugs in the adenosine A2a receptor antagonist class
- Fipamezole (JP-1730)
- SCH-420814 analog
- BIIB-014/V2006
- Drugs with neuroprotective potential
- Pipeline summary
- E2007
- Drug overview
- Forecasts to 2016
- Marketing factors
- Patient potential
- Satisfaction of unmet needs
- Clinical trial data
- Ongoing Phase III trials
- PD-02 (creatine)
- Paliroden (SR-57667)
- Ongoing clinical trials
- Datamonitor comments
- GM1 ganglioside
- Drug overview
- Clinical trials
- Phase II study of GM1 ganglioside in mild to moderate PD
- NCT00037830-Phase II study of GM1 ganglioside in mild to moderate PD
- Kinampa (talampanel)
- Drug overview
- Clinical trials
- FP-0011
- Drug overview
- Clinical trials
- Cereact Capsule (ONO-2506PO)
- Others drug classes in the current pipeline
- Pipeline summary
- Pimavanserin (ACP-103)
- Forecasts to 2016
- Marking factors
- Patient potential
- Satisfaction of unmet needs
- Clinical trials
- Ongoing clinical trials
- Zonegran (zonisamide)
- Drug overview
- Clinical trials
- Keppra (levetiracetam)
- Clinical trials
- Ongoing studies
- Patient potential and marketing factors
- CHAPTER 7 CELL/GENE THERAPIES AND EARLY-STAGE PROJECTS
- Cell/gene therapy
- Pipeline summary
- The role of cell and gene therapies in Parkinson' s disease
- Spheramine (RPE cell therapy)
- Overview
- Clinical trials
- Ongoing trials-STEPS Phase II double-blind study
- AV-201
- CERE-120
- Overview
- Preclinical animal studies
- Phase I trial-proof of concept in humans
- Ongoing Phase II clinical trial
- ProSavin
- Overview-only in preclinical development but a promising candidate
- Trials due to start in Q4 2007
- Key Phase I compounds in PD
- BIBLIOGRAPHY
- APPENDIX
- Report methodology
- About Datamonitor
- About Datamonitor Healthcare
- About the CNS analysis team
- Disclaimer
- List of Tables
- Table 1: Prevalence of PD across the seven major markets, 2007
- Table 2: Mirapex patent expiry dates, US and 5EU
- Table 3: Study design-assessment of pramipexole in early PD
- Table 4: Study design for the assessment of pramipexole in early PD
- Table 5: Adverse events occurring in >5% of early PD patients on
pramipexole as a monotherapy
- Table 6: Study design for pramipexole in advanced PD with levodopa
- Table 7: Key results from study of pramipexole versus placebo in
advanced PD with levodopa
- Table 8: Adverse events occurring in >5% of advanced PD patients
treated with pramipexole in addition to levodopa
- Table 9: Number of adverse events occurring with Neupro and placebo
- Table 10: Study design in the assessment of rotigotine CDS in early PD
- Table 11: Key results from large-scale studies of rotigotine CDS in
treating patients with early PD
- Table 12: Commonly occurring adverse events that were more frequent in
those treated with rotigotine than placebo
- Table 13: Results from the North American study (SEESAW) of entacapone
in patients experiencing ON and OFF periods despite optimized levodopa
therapy
- Table 14: Results from the Nordic study (NOMECOMT) of entacapone in
patients experiencing ON and OFF periods despite optimized levodopa therapy
- Table 15: Results from the German-Austrian study of entacapone in
patients taking levodopa-DDI and experiencing "wearing off"
- Table 16: Adverse events occurring in ≥5% of entacapone patients
- Table 17: Forecast launch dates in the US and 5EU
- Table 18: Forecast launch dates in Japan
- Table 19: Pivotal patent expires for key marketed drugs in the US and
5EU
- Table 20: Unified PD Rating Scale-cognition, behavior and mood
- Table 21: The five stages of PD according to the Hoehn and Yahr scale
- Table 22: Key pipeline drugs in late-stage development for PD, 2007
- Table 23: Late-stage development pipeline, dopaminergic class, 2006
- Table 24: Key factors impacting sales of V1512, 2007-16
- Table 25: Phase II studies of V1512 conducted by Chiesi
- Table 26: Phase III studies of V1512 conducted by Chiesi
- Table 27: Late-stage development pipeline, dopamine agonist class, 2007
- Table 28: Key factors impacting sales of Requip Modutab, 2007-16
- Table 29: Key factors impacting sales of SLV-308, 2007-16
- Table 30: Late-stage development pipeline, COMT class, 2007
- Table 31: Late-stage development pipeline, MAOI class, 2007
- Table 32: Key factors impacting the sales of safinamide, 2007-16
- Table 33: Late-stage development pipeline, adenosine A2a receptor
antagonist class, 2007
- Table 34: Factors impacting sales of istradefylline, 2007-16
- Table 35: Late-stage development pipeline, neuroprotective potential
class, 2007
- Table 36: Factors impacting on the sales of E2007, 2007-16
- Table 37: Change in UPDRS score from baseline to 12 months or the need
for symptomatic therapy (whichever first)
- Table 38: Late-stage development pipeline, others class, 2007
- Table 39: Factors impacting sales of pimavanserin, 2007-16
- Table 40: Phase II trial results for pimavanserin
- Table 41: Key cell/gene therapies in development for PD, 2007
- Table 42: Projects in Phase I development for PD, 2006
- Table 43: Datamonitor drug assessment parameters
- List of Figures
- Figure 1: Drug assessment summary overview of key marketed and
pipeline Parkinson' s disease drugs, 2007
- Figure 2: Historical (2003-06) and forecast (2007-16) PD sales revenue
for key marketed and pipeline drugs across the 7MM
- Figure 3: Aging population across the seven major markets (%),
2000-2050
- Figure 4: Key unmet needs in PD, 2007
- Figure 5: Levodopa dose required to relieve symptoms compared to dose
required to induce dyskinesias
- Figure 6: Pharmacological treatment algorithm for PD
- Figure 7: Mechanism of action of levodopa therapy
- Figure 8: Mechanism of action of AADC inhibitors (DDIs)
- Figure 9: Mechanism of action of COMT inhibitor (entacapone)
- Figure 10: Mechanism of action of MAO-B inhibitors
- Figure 11: PD-specific sales revenue, 7MM, 2003-06
- Figure 12: PD-specific IMS standard unit volume, 7MM, 2003-06
- Figure 13: PD-specific sales revenue by region and country, 2006
- Figure 14: PD total market value in the US, Japan and 5EU, 2003-16
- Figure 15: Current marketed drugs-clinical and commercial assessment
- Figure 16: Sales (2006) and sales growth (2005-06) for key PD products
- Figure 17: Mirapex SWOT analysis, 2007
- Figure 18: Branded Mirapex PD sales revenue, 7MM, 2003-16
- Figure 19: Key results from six month trial of pramipexole monotherapy
versus placebo in treating patients with early PD
- Figure 20: Key results from mixed-dose study of pramipexole
monotherapy versus placebo in treating patients with early PD
- Figure 21: Neupro SWOT analysis, 2007
- Figure 22: Neupro PD-specific sales revenue, 7MM, 2003-16
- Figure 23: Sales revenue generated by Neupro, Q1 2006-Q1 2007.
- Figure 24: Diagrammatic representation of Neupro' s mode of action
- Figure 25: Change in UPDRS-II-III scores compared to placebo for
groups taking 2-8mg/24hr of rotigotine
- Figure 26: UPDRS part II and III scores with Neupro versus placebo
- Figure 27: Study SP512 results-comparison of rotigotine versus placebo
in early PD over 24 weeks maintenance
- Figure 28: Study SP513 results-comparison of rotigotine versus
ropinirole and placebo in early PD over 24-week maintenance period
- Figure 29: Comtan SWOT analysis, 2007
- Figure 30: Branded Comtan PD sales revenue, 7MM, 2003-16
- Figure 31: Key results from the North American study (SEESAW) of
entacapone in patients experiencing ON and OFF periods despite optimized
levodopa therapy
- Figure 32: Key results from the Nordic study (NOMECOMT) of entacapone
in patients experiencing ON and OFF periods despite optimized levodopa
therapy
- Figure 33: Stalevo SWOT analysis, 2007
- Figure 34: Stalevo PD sales revenue, 7MM, 2003-16
- Figure 35: Selegiline formulations sales revenue, 7MM, 2003-06
- Figure 36: Total selegiline PD sales, 7MM, 2003-16
- Figure 37: Azilect SWOT analysis, 2007
- Figure 38: Azilect PD sales revenue, 7MM, 2003-16
- Figure 39: TEMPO study-change in UPDRS score with 1mg/day rasagiline
versus placebo over six months
- Figure 40: TEMPO study-change in UPDRS score with rasagiline versus
placebo over 12 months
- Figure 41: Change over 18 weeks in the LARGO study of rasagiline as an
adjunct to treatment in patients with moderate-to-advanced PD
- Figure 42: 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 43: 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 44: 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 45: Impact of each key event on the PD market across the seven
major markets, 2007-2016
- Figure 46: Late-stage pipeline overview, 2007
- Figure 47: PD-specific sales revenue of melevodopa formulations in
Italy, 2003-06
- Figure 48: Forecast PD sales for V1512, 7MM, 2007-16
- Figure 49: Drug assessment summary for V1512, 2007
- Figure 50: Vernalis' s potential PD portfolio
- Figure 51: Forecast PD sales for Requip Modutab across the seven major
markets, 2007-16
- Figure 52: Drug assessment summary for Requip Modutab, 2007
- Figure 53: Forecast PD sales for SLV-308, 7MM, 2007-16
- Figure 54: Drug assessment summary for SLV-308, 2007
- Figure 55: SLV-308 Phase II data
- Figure 56: Forecast PD sales for safinamide, 7MM, 20-2016
- Figure 57: Drug assessment summary for safinamide, 2007
- Figure 58: Forecast PD sales for istradefylline, 7MM, 2007-16
- Figure 59: Drug assessment summary for istradefylline, 2007
- Figure 60: Forecast PD sales for E2007, 7MM, 2007-16
- Figure 61: Drug assessment summary for E2007, 2007
- Figure 62: E2007 proof-of-concept Phase IIb trial results
- Figure 63: Forecast PD sales for pimavanserin, 7MM, 2007-16
- Figure 64: Drug assessment summary for pimavanserin, 2007
- Figure 65: AADC involvement in the metabolism of levodopa
- Figure 66: Diagrammatic representation of the proposed mode of action
of CERE-120 treatment
- Figure 67: Increased expression of the neurotrophic factor neurturin
in rats following CERE-120 treatment
- Figure 68: 18F-Dopa PET scans of treated and untreated hemispheres of
monkey brains
- Figure 69: PD symptom improvement in MPTP lesioned monkeys
- Figure 70: Diagrammatic representation of the mode of action of
ProSavin
- Figure 71: Results showing the effects of ProSavin in MPTP-treated
primates
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