Market Report Source

Overview

Introduction
The PD market is set to continue to grow over the next 7 years, reaching over $2.37 billion in 2013, a 39% increase from 2006 levels. Combinations, reformulations, and indication expansions will drive the majority of this growth, with key brands expected to be Novartis/Orion’s Stalevo, GlaxoSmithKline’s (GSK’s) Requip Modutab, and UCB-Schwarz’s Neupro.

Scope

• Analysis of patient potential, unmet needs and clinical trial design in PD
• Overview of key marketed brands, late- and early-stage pipeline drugs, and cell/gene therapies. Indication- and country-specific sales volume and value forecasts to 2016 of marketed brands, generics, and key late-stage pipeline drugs
• Identification of future market events that are expected to affect PD drug revenues

Highlights
GSK’s Requip Modutab will become the market leading PD brand in 2011. It will be intuitive for prescribers to believe that sustained activation of dopamine receptors with Requip Modutab could have a significant clinical benefit over pulsed agonism with standard drugs. New pipeline drugs will need to be innovative to compete in an increasingly crowded market. While this is evident in Eisai’s E2007, it is lacking in Merck-Serono/Newron’s safinamide. Early studies with cell/gene therapies show great promise for significantly slowing the progression of the disease. However, these alternative approaches will not significantly impact the sales of pharmaceuticals over the forecast period 20072016.

Reasons to Purchase

• Benchmark key late-stage PD compounds against current market leading brands
• Assess country-specific (US, Japan, France, Germany, Italy, Spain and the UK) sales forecasts of key late-stage pipeline drugs and marketed brands
• Understand unmet needs and opportunities in the PD market based on key opinion leader comments

Table of Contents

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)

Phase II clinical trials

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

Overview

Clinical trials

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

Phase I overview

BIBLIOGRAPHY

Journal papers

Websites

APPENDIX

Report methodology

Contributing experts

About Datamonitor

About Datamonitor Healthcare

About the CNS analysis team

Disclaimer

List of Tables