Stakeholder Opinions: Traumatic Brain Injury Hormonal therapy generates optimism

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Stakeholder Opinions: Traumatic Brain Injury Hormonal therapy
generates optimism
Published on April 2010

Report Summary

Introduction

There remains no approved pharmacological or cellular treatment to improve the outcome of survivors of traumatic brain injury (TBI).
In the past two decades, understanding of the cellular and molecular mechanisms that occur after TBI has grown and a combination
of novel therapeutic strategies and approved molecules are presently being examined in clinical trials.

Scope

*Analysis of the patient potential of traumatic brain injury across the seven major markets and several rest of world markets.

*Review of key unmet clinical needs in the treatment of traumatic brain injury and current pipeline treatments.

*Identification of key opportunities and threats facing developers of treatments for traumatic brain injury.

*Insight from six internationally recognized key opinion leaders in the field of spinal cord injuries.

Highlights

The incidence of hospitalized cases of TBI is estimated to be higher than the annual incidence of several medical conditions including
some cancer types, epilepsy, HIV/AIDS, multiple sclerosis and spinal cord injury. Therefore, developers of efficacious treatments for
TBI stand to benefit from a sizeable patient population.

Despite the high level of unmet need in the treatment of TBI, TBI research is under-funded. The current situation may stem from poor
awareness of TBI, pessimism resulting from the relatively high attrition rate in the TBI pipeline and the perception that an efficacious
pharmacological treatment for TBI is unattainable.

A sizeable proportion of the clinical candidates are under development as neuroprotective treatments for TBI. The inclusion of two
progesterone receptor agonists in the current pipeline is indicative of the rising level of optimism regarding the neuroprotective
potential of progesterone in TBI.

Reasons to Purchase

*Quantify the incidence of hospitalized cases of TBI across the seven major pharmaceutical markets and identify key clinical unmet
needs.

*Assess the opportunities and threats facing developers in the traumatic brain injury market.

*Utilize pipeline product profiles to identify potential in-licensing opportunities.

Stakeholder Opinions: Traumatic Brain Injury Hormonal therapy generates optimism Page 1/7


Table of Content

Overview 1
Catalyst 1
Summary 1
About Datamonitor Healthcare 2
About the Central Nervous System pharmaceutical analysis team 2
Executive summary 3
Strategic scoping and focus 3
Datamonitor insight into the traumatic brain injury market 3
Related reports 4
TABLE OF CONTENTS 5
1. Patient Potential 6
Key findings 6
Definition of traumatic brain injury 7
Symptoms of traumatic brain injury 7
Classification of traumatic brain injury 9
Closed versus penetrating brain injury 9
Focal and diffuse injury 9
Measure of severity: the Glasgow Coma Scale 9
Measure of severity: duration of loss of consciousness 10
Etiology of traumatic brain injury 11
Falls and motor vehicle crashes account for over half of cases of traumatic brain injury 11
Pathophysiology of traumatic brain injury 12
Primary injury 13
Secondary injury 13
Excitatory amino acids 14
Endogenous opioid peptides 14
Increased intracranial pressure 14
Diagnosis of traumatic brain injury 14
Initial trauma assessment 15
Brain imaging 15
Neuropsychological examination 15
Epidemiology of traumatic brain injury 16
The prevalence and incidence of traumatic brain injury is difficult to assess accurately 16
Seven major markets 17
Hospitalized and fatal cases of traumatic brain injury expected to exceed 1.1 million across the seven major markets in 2010 17
Rest of the world 20
Published research indicates that Sweden has a high incidence of traumatic brain injury 20
Epidemiological trends in traumatic brain injury 22
Gender: men are approximately 1.4 times as likely to sustain a traumatic brain injury than women 22
Age: children, older adolescents and adults 75 years and older are most likely to sustain a TBI 23
Medical complications associated with traumatic brain injury 24
Traumatic brain injury poses a common and well-recognized risk of developing epilepsy 24
Traumatic brain injury appears to increase the risk of developing Alzheimer's disease and Parkinson's disease 25
Mortality 26



Traumatic brain injury-related death is considerably higher among men than women 26
Traumatic brain injury carries a high economic impact 26
2. Patient Care Path and Unmet Needs 28
Key findings 28
Patient care path 29
The acute hospital setting and intensive care unit are key intervention point for neuroprotective treatments 30
For manufacturers of neurorestorative treatments, rehabilitation and community settings are key targets 31
Unmet need in traumatic brain injury 31
Neuroprotective treatments 32
Neurorestorative treatments 34
Symptomatic treatment 35
Efficacious treatments for cognitive deficits associated with TBI 35
3. Market Potential 38
Key findings 38
Traumatic brain injury: opportunities and threats 39
Opportunities 39
Eligibility for orphan drug status 39
TBI offers developers a substantially greater patient potential than several other medical conditions 42
High revenue generating potential for efficacious treatments 44
Efficacious treatments in TBI possess applications in other conditions 44
Lifting of restrictions on human embryonic stem cell research in the US 45
Threats 46
Research for traumatic brain injury is under-funded 46
Potential reversal of US stem cell regulations 47
4. Pipeline Analysis 49
Key findings 49
Clinical pipeline overview 50
Cephalon and Abbott are the only Big Pharma firms in the current clinical pipeline for traumatic brain injury 50
Progesterone represents the most prevalent active ingredient in the current pipeline 53
The pipeline is dominated by neuroprotective treatments for TBI 54
Nuvigil (armodafinil; Cephalon) 55
Drug profile: marketed treatment for excessive sleepiness seeking indication expansion into TBI 55
Development overview 55
Recruitment is ongoing for two Phase III trials of Nuvigil in TBI patients with excessive sleepiness 55
There are no currently published clinical trial data for Nuvigil as a treatment for excessive sleepiness in TBI 57
Product positioning 59
Nuvigil may be the first drug approved for the treatment of excessive sleepiness associated with TBI 59
SWOT analysis 61
BHR-100 (progesterone; BHR Pharma) 62
Drug profile: Progesterone receptor agonist in development as a neuroprotective treatment for TBI 62
Phase II clinical trial results: progesterone demonstrates mortality benefit in TBI patients 63
Phase III, multicenter pivotal trial (SyNAPSe study) of BHR-100 to be initiated in early 2010 64
BHR-100 has the potential to become the first neuroprotective treatment approved for TBI 67
If approved, BHR-100 will be used as an acute neuroprotective treatment in the emergency medical setting 67
SWOT analysis 67
NNZ-2566 (Neuren Pharmaceuticals) 68
Drug profile: intravenous caspase-3 inhibitor in development as a neuroprotective treatment for TBI 68



Phase II trial of NNZ-2566 in TBI patients was due to commence in March 2010 69
Completed Phase Ia and Ib trials demonstrate positive results 71
If approved, NNZ-2566 will be used as an acute neuroprotective treatment in the emergency medical setting 71
SWOT analysis 71
NH001 (apomorphine; NeuroHealing Pharmaceuticals) 73
Drug profile: dopaminergic agent to help post-TBI patients regain consciousness 73
Participant recruitment for Phase II efficacy study of NH001 has yet to commence 74
Case report of administration of NH001 to MCS patient published in February 2009 75
Clinical data for NH001 presented at the American Society for Experimental NeuroTherapeutics in 2007 76
NH100 has the potential to become the first drug approved for the treatment of vegetative/minimally conscious state 76
SWOT analysis 77
Oxycyte (Oxygen Biotherapeutics) 78
Drug profile: perfluorocarbon therapeutic oxygen carrier for traumatic brain injury 78
Participant enrolment for Phase II clinical trial commenced in December 2009 79
Oxycyte achieved primary endpoint in Phase IIa traumatic brain injury trial 80
VAS-203 (Vasopharm) 82
Drug profile: allosteric nitric oxide synthase inhibitor targets both brain vasculature and parenchyma 82
Initiation of Phase II trial of NNZ-2566 in TBI patients was due to be initiated in March 2010 82
VAS203 found to be safe and well-tolerated in Phase I study 82
Zolpidem REGEN (ReGen Therapeutics) 83
Drug profile: sublingual formulation of zolpidem for the treatment of brain dormancy 83
Zolpidem shown to significantly improve cognitive and motor performance of patients with brain damage 83
KN38-7271 (KeyNeurotek Pharmaceuticals) 86
Drug profile: dual cannabinoid receptor agonist for traumatic brain injury 86
Phase IIa study demonstrates significant increase in survival in patients with severe TBI 86
NTx428 (stem cell proliferative agents and erythropoietin; Stem Cell Therapeutics) 88
Preclinical/discovery pipeline overview 89
Discontinued pipeline candidates for traumatic brain injury 91
The future of treatment in traumatic brain injury 93
Progesterone therapy predicted to be the standard of care 93
Key opinion leaders believe that successful treatment of TBI requires combination therapies 95
Bibliography 96
Books and journal papers 96
Websites 105
Datamonitor reports 111
Appendix 112
Contributing experts 112
Conferences attended 112
Report methodology 112



About Datamonitor 113
About Datamonitor Healthcare 113
About the Central Nervous System pharmaceutical analysis team 114
Disclaimer 115
List of Tables
Table 1: Classification of traumatic brain injury according to the Glasgow Coma Scale 10
Table 2: Severity of traumatic brain injury based on duration of loss of consciousness 11
Table 3: Studies of the incidence of traumatic brain injuries In the seven major markets 18
Table 4: Incidence of hospitalized cases of traumatic brain injury in the seven major markets, 2010 19
Table 5: Studies of the incidence of traumatic brain injuries in the rest of the world 21
Table 6: Incidence of traumatic brain injury in the rest of world markets, 2010 22
Table 7: Average annual numbers of traumatic brain injury-related emergency department visits, hospitalizations and deaths by sex in
the US, 2002-2006 23
Table 8: Traumatic brain injury market opportunities and threats 39
Table 9: Products in clinical development for traumatic brain injury, 2010 53
Table 10: Nuvigil (armodafinil, Cephalon)- drug profile, 2010 55
Table 11: Key facts: 12-week Phase III trial of Nuvigil (armodafinil) in TBI patient 56
Table 12: Key facts: 12-month Phase III trial of Nuvigil (armodafinil) in TBI patients 57
Table 13: Results of published studies investigating the efficacy of Nuvigil (armodafinil, Cephalon) in the treatment of excessive
sleepiness associated with narcolepsy, shift work disorder and obstructive sleep apnea/hypopnea syndrome 58
Table 14 : BHR-100 (progesterone, BHR Pharma) - drug profile, 2010 63
Table 15: Key facts: Phase III, SyNAPSe trial of BHR-100 (BHR Pharma) in severe TBI 66
Table 16: NNZ-2566 (Neuren Pharmaceuticals) - drug profile, 2010 69
Table 17: Key facts: Phase II trial of NNZ-2566 in traumatic brain injury 70
Table 18: NH001 (NeuroHealing Pharmaceuticals) - drug profile, 2010 73
Table 19: Key facts: Phase II trial of NH001 75
Table 20: Oxycyte (Oxygen Biotherapeutics) - drug profile, 2010 79
Table 21: Key facts: Phase II trial of Oxycyte 80
Table 22: KN38-7271 (KeyNeurotek Pharmaceuticals AG) - drug profile, 2010 86
Table 23: Products in preclinical and discovery for traumatic brain injury, 2010 90
Table 24: Key discontinued R&D projects in spinal cord injury 91
List of Figures
Figure 1: Key cognitive, physical and behavioral symptoms of traumatic brain injury 8
Figure 2: Key causes of annual traumatic brain injury-related emergency department visits, hospitalizations and deaths in the US,
2002-2006 12
Figure 3: Traumatic brain injury patient care path 29
Figure 4: Key unmet clinical needs in traumatic brain injury, 2010 32
Figure 5: Comparison of incentives conferred by orphan product policies across the US, EU and Japan, 2010 41
Figure 6: Annual incidence of all cases of TBI versus six other medical conditions in the US 43
Figure 7: Composition of clinical pipeline for traumatic brain injury by stage of development, 2010 50
Figure 8: Nuvigil (armodafinil, Cephalon): SWOT analysis 62
Figure 9: Intravenous progesterone (BHR-100, BHR Pharma): Phase II trial results 64
Figure 10: BHR-100 (BHR Pharma): SWOT analysis 68
Figure 11: NNZ-2566 (Neuren Pharmaceuticals): SWOT analysis 72
Figure 12: NH001 (NeuroHealing Pharmaceuticals): SWOT analysis 78
Figure 13: Prospective study of zolpidem in patients with brain damage 84
Figure 14: Phase IIa proof-of-concept study of KN38-7271 (KeyNeurotek Pharmaceuticals) in patients with severe TBI 87



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Stakeholder Opinions: Traumatic Brain Injury Hormonal therapy generates optimism

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Stakeholder Opinions: Traumatic Brain Injury Hormonal therapy generates optimism