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Amyotrophic Lateral Sclerosis: A route to larger CNS markets?


Description: Amyotrophic Lateral Sclerosis (ALS) is an orphan neurodegenerative disease which effects approximately 11,000 people across the seven major markets. ALS is set to provide a platform for drugs use more widespread conditions such as Parkinson's Disease (PD) or Alzheimer's Disease (AD). This Brief provides an insight into key drugs currently in clinical trials for ALS using key opinion leader primary research to validate conclusions. ALS is one of many orphan diseases in the CNS arena. If significant return of investment is to be realized in this market, both existing and future players must address the lack of disease awareness amongst physicians. This research believes that educating physicians is key to improving diagnosis and treatment rates, in addition to establishing good relationships with ALS research organizations. Currently the only prescription drug approved for ALS is Aventis' Rilutek (riluzole). Despite the fact that many physicians doubt its true therapeutic value, Rilutek sales still topped $100m in 2002. This demonstrates the scope for commercial opportunities within the ALS market. Scope and coverage - Epidemiology and prevalence data - Current treatment and unmet market needs - Analysis of trial data, the therapeutic potential of current and future drugs and drug classes - Analysis of key issues in the ALS and orphan disease market supported by key opinion leader interviews Key findings and highlights - ALS is one of many orphan diseases in the CNS arena. If significant return of investment is to be realized in this market, both existing and future players must address the lack of disease awareness amongst physicians. - Currently the only prescription drug approved for ALS is Aventis Rilutek (riluzole). Despite the fact that, many physicians doubt its true therapeutic value, Rilutek sales topped $100m in 2002. This demonstrates the scope for commercial opportunities which can be further increased by seeking approval for lucrative indications such as AD or PD. Why should you buy this brief? - Assess the ALS patient potential - Identify the key unmet needs and diagnostic tools, which would highlight novel targets - Review the therapeutic and commercial potential of drugs and compounds in clinical trials based on ALS expert opinion and trial data


Contents: EXECUTIVE SUMMARY 4

Introduction 4
Scope and coverage of the Brief 4
Key Findings 5

DISEASE OVERVIEW 8

Symptomatology 8
Etiology 9
Prevalence 10
Diagnosis rate 11
Treatment rates 13
Unmet needs 13

TREATMENT 14

Disease-modifying treatments 14
Symptomatic treatments 16
Non-pharmacological treatment 16

R&D PIPELINE 18

Introduction 18

Marketed drugs in clinical trials for ALS 20
- Celebrex (celecoxib) 20
- Clinical trials for ALS 20
- Minocin (minocycline) 20
- Clinical trials for ALS 21
- Xaliproden (SR57746A) 21
- Summary of other research 22
- Topamax (topiramate) 22
- Nolvadex (tamoxifen) 22
- Neurontin (gabapentin) 23
- Oxandrolone 23
- Buspar (buspirone) 23
- ONO-2506PO 24

Over-the-Counter Drugs for ALS in clinical trials 24
- Creatine 24

Clinical trials for ALS 24

Therapeutic advances and potential market opportunities 25
Pipeline drugs for ALS 26
- Caspase inhibitors 26
- SC236 27
- Neotrofin (leteprinim) 27
- TCH-346 28
- Neurodex (AVP-923) 28
- EHT 0201/0202 29

STRATEGIC OPPORTUNITIES AVAILABLE TO COMPANIES 30

Introduction 30
Strategic opportunites 30
The orphan drug issues in ALS 31
- US 32
- Japan 33
- EU 34

APPENDIX 36

Contributing experts 36
Bibliography 36
Web sites 39
Disclaimer 41

List of Tables

Table 1: Prevalence of ALS across the seven major markets, 2003 11
Table 2: El Escorial criteria for the clinical diagnosis of ALS 12
Table 3: Global sales of Rilutek (2001–02) 14
Table 4: Symptomatic treatments 16
Table 5: Pipeline Drugs – ALS 19

List of Figures




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