What's Next in Vaccines June 2012

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T A B L E

O F

C O N T E N T S

CHAPTER ONE: EXECUTIVE SUMMARY .........................................................1

Emerging Vaccines.............................................................................................................. 1
Scope and Methodology ................................................................................................... 1
Overview .......................................................................................................................... 2
Emerging Vaccines and Forecasts .................................................................................... 3
The Global Market for Emerging Vaccines ...................................................................... 4

CHAPTER TWO: INTRODUCTION TO VACCINES ..........................................7

A Brief History: The Development of Vaccines .............................................................. 8
The Immune Response........................................................................................................ 9
Mechanism of Action .......................................................................................................... 9
Types of Vaccines .............................................................................................................. 10
Attenuated (Weakened) Live Viruses ............................................................................. 10
Killed (Inactivated) Viruses ............................................................................................ 12
Toxoid Vaccines ............................................................................................................. 13
Genetically Engineered/Modified Vaccines ................................................................... 13
Bacteria-Based Vaccines ................................................................................................ 13
Vaccine Approval Process ................................................................................................ 15
Refusal to Immunize ......................................................................................................... 17
Expanding Vaccine Availability ...................................................................................... 18
Other Trends Driving the Vaccines Market ................................................................... 19

CHAPTER THREE: EMERGING VACCINES ....................................................23

Introduction ....................................................................................................................... 23
Emerging Vaccines by Disease Area ............................................................................... 23
Acne ................................................................................................................................ 33
Addiction ........................................................................................................................ 34
Allergy ............................................................................................................................ 40
Alzheimers Disease ....................................................................................................... 43
Anthrax ........................................................................................................................... 46
Asthma ............................................................................................................................ 49
Campylobacter Infection ................................................................................................ 50
Celiac Disease ................................................................................................................. 52
Chlamydia ....................................................................................................................... 53
Croup .............................................................................................................................. 55
Cytomegalovirus (CMV) ................................................................................................ 57
Dengue Fever .................................................................................................................. 58
Diabetes .......................................................................................................................... 61
Ebola ............................................................................................................................... 65
Epstein-Barr Virus .......................................................................................................... 69

Enterotoxigenic Escherichia coli (ETEC ........................................................................ 71

Heart Attack .................................................................................................................... 74
Helicobacter Pylori ......................................................................................................... 77
Hepatitis .......................................................................................................................... 80
Herpesvirus ..................................................................................................................... 83
Hookworm ...................................................................................................................... 85
Hypertension ................................................................................................................... 87
HIV/AIDS ....................................................................................................................... 89
Leishmaniasis ................................................................................................................. 95
Malaria ............................................................................................................................ 97
MRSA Infection............................................................................................................ 100
Multiple Sclerosis ......................................................................................................... 103
Obesity .......................................................................................................................... 105
Parainfluenza Virus Type 3 .......................................................................................... 110
Parkinsons Disease ...................................................................................................... 111
Plague ........................................................................................................................... 114
Ross River Virus ........................................................................................................... 117
Shigellosis ..................................................................................................................... 118
Stroke ............................................................................................................................ 121
Tuberculosis.................................................................................................................. 123
West Nile Virus ............................................................................................................ 127

CHAPTER FOUR: EMERGING VACCINES MARKET FORECAST ...........131

The Global Market for Emerging Vaccines ................................................................... 131
Emerging Vaccines Market Segment Forecasts ........................................................... 135
Acne .............................................................................................................................. 135
Addiction ...................................................................................................................... 138
Allergies........................................................................................................................ 140
Alzheimers Disease ..................................................................................................... 140
Anthrax ......................................................................................................................... 143
Asthma .......................................................................................................................... 143
Campylobacter Infection .............................................................................................. 145
Celiac Disease ............................................................................................................... 146
Chlamydia ..................................................................................................................... 147
Croup ............................................................................................................................ 149
Diabetes ........................................................................................................................ 153
Ebola ............................................................................................................................. 154
EBV Infection ............................................................................................................... 155
ETEC Infection ............................................................................................................. 157
Heart Attack .................................................................................................................. 158
H. Pylori Infection ........................................................................................................ 160
Hepatitis C and E .......................................................................................................... 162
Herpesvirus Infection.................................................................................................... 163
Hookworm .................................................................................................................... 164
Hypertension ................................................................................................................. 165
HIV/AIDS ..................................................................................................................... 166
Leishmaniasis ............................................................................................................... 168
Malaria .......................................................................................................................... 169
MRSA Infection............................................................................................................ 171
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Multiple Sclerosis ......................................................................................................... 172

Obesity .......................................................................................................................... 173
PIV-3 Infection ............................................................................................................. 175
Parkinsons Disease ...................................................................................................... 176
Plague ........................................................................................................................... 177
RSV Infection ............................................................................................................... 179
Ross River Virus Infection ........................................................................................... 180
Shigellosis ..................................................................................................................... 181
Stroke ............................................................................................................................ 183
Tuberculosis.................................................................................................................. 184
West Nile Virus ............................................................................................................ 185

CHAPTER FIVE: ISSUES AND TRENDS ...........................................................187

New Vaccine Delivery Systems ...................................................................................... 188
Edible Vaccines ............................................................................................................ 189
Mucosal Delivery .......................................................................................................... 191
Intranasal Delivery ....................................................................................................... 192
Vaccine Patches ............................................................................................................ 193
Funding Shortfalls .......................................................................................................... 194
Project Terminations ...................................................................................................... 194

CHAPTER SIX: COMPANY PROFILES.............................................................197

Affiris ............................................................................................................................... 197
History and Lines of Business ...................................................................................... 197
Emerging Vaccine Activities ........................................................................................ 197
Financial Information ................................................................................................... 198
Alk-Abello A/S ................................................................................................................. 199
History and Lines of Business ...................................................................................... 199
Emerging Vaccine Activities ........................................................................................ 199
Financial Information ................................................................................................... 200
Allergy Therapeutics ...................................................................................................... 201
History and Lines of Business ...................................................................................... 201
Emerging Vaccine Activities ........................................................................................ 201
Financial Information ................................................................................................... 202
AstraZeneca ..................................................................................................................... 203
History and Lines of Business ...................................................................................... 203
Emerging Vaccine Products ......................................................................................... 203
Financial Information ................................................................................................... 203
Bavarian Nordic A/S ....................................................................................................... 204
History and Lines of Business ...................................................................................... 204
Emerging Vaccine Activities ........................................................................................ 204
Financial Information ................................................................................................... 205
Baxter Healthcare ........................................................................................................... 206
History and Lines of Business ...................................................................................... 206
Emerging Vaccine Activities ........................................................................................ 207
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in whole or in any part, is strictly prohibited.

Financial Information ................................................................................................... 207

Crucell .............................................................................................................................. 208
History and Lines of Business ...................................................................................... 208
Emerging Vaccine Activities ........................................................................................ 209
Financial Information ................................................................................................... 210
Cytos Biotechnology........................................................................................................ 211
History and Lines of Business ...................................................................................... 211
Emerging Vaccine Activities ........................................................................................ 211
Financial ....................................................................................................................... 212
GlaxoSmithKline ............................................................................................................. 213
History and Lines of Business ...................................................................................... 213
Emerging Vaccine Activities ........................................................................................ 214
Financial Information ................................................................................................... 215
Hawaii Biotech ................................................................................................................ 216
History and Lines of Business ...................................................................................... 216
Emerging Vaccine Products ......................................................................................... 216
Financial Information ................................................................................................... 217
Merck & Co. Inc ............................................................................................................. 218
History and Lines of Business ...................................................................................... 218
Emerging Vaccine Activities ........................................................................................ 219
Financial Information ................................................................................................... 219
Mymetics .......................................................................................................................... 220
History and Lines of Business ...................................................................................... 220
Emerging Vaccine Products ......................................................................................... 220
Financial Information ................................................................................................... 220
Nabi Biopharmaceuticals ............................................................................................... 221
History and Lines of Business ...................................................................................... 221
Emerging Vaccine Activities ........................................................................................ 221
Financial Information ................................................................................................... 222
Novartis ............................................................................................................................ 223
History and Lines of Business ...................................................................................... 223
Emerging Vaccine Activities ........................................................................................ 223
Financial Information ................................................................................................... 224
Opexa Therapeutics ........................................................................................................ 225
History and Lines of Business ...................................................................................... 225
Emerging Vaccine Activities ........................................................................................ 225
Financial Information ................................................................................................... 226
Sanofi Pasteur.................................................................................................................. 227
History and Lines of Business ...................................................................................... 227
Emerging Vaccine Activities ........................................................................................ 228
Financial Information ................................................................................................... 229

APPENDIX: COMPANY DIRECTORY ...............................................................230

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CHAPTER ONEEXECUTIVE SUMMARY

Table 1-1: Status of Emerging Vaccines by Disease ........................................................ 5

CHAPTER TWO: INTRODUCTION TO VACCINES

Table 2-1: Impact of Vaccines in the 20th Century Annual Morbidity in the 20th Century
vs 2011 .................................................................................................................................. 8
Table 2-2: Vaccine-Preventable Diseases, December 2011............................................ 11
Figure 2-1: Attenuated Virus Production ....................................................................... 12
Table 2-3: VAERS Table of Reportable Events Following Vaccination ...................... 21

CHAPTER THREE: EMERGING VACCINES

Figure 3-1: Global Prevalence of Conditions Addressed by Emerging
Vaccines, 2012 .................................................................................................................. 27
Figure 3-2: Comparative Mortality, Symptom Severity and
Treatment Availability for Conditions Addressed by Emerging Vaccines .................. 28
Table 3-1: Emerging Vaccines by Disease and Stage of Testing ................................... 29
Figure 3-3: Comparative Severity Ranking of Acne ...................................................... 34
Figure 3-4: Comparative Severity Ranking of Addiction ............................................. 35
Figure 3-5: Comparative Severity Ranking of Allergy .................................................. 41
Figure 3-6: Comparative Severity Ranking of Alzheimers Disease ............................ 44
Figure 3-7: Comparative Severity Ranking of Anthrax ................................................ 47
Figure 3-8: Comparative Severity Ranking of Asthma ................................................. 50
Figure 3-9: Comparative Severity Ranking of Campylobacter Infection .................... 51
Figure 3-10: Comparative Severity Ranking of Celiac Disease .................................... 52
Figure 3-11: Comparative Severity Ranking of Chlamydia ......................................... 54
Figure 3-12: Comparative Severity Ranking of Croup ................................................. 55
Figure 3-13: Comparative Severity Ranking of Cytomegalovirus ............................... 57
Figure 3-14: Comparative Severity Ranking of Dengue Fever ..................................... 59
Figure 3-15: Comparative Severity Ranking of Diabetes .............................................. 62
Figure 3-16: Comparative Severity Ranking of Ebola .................................................. 66
Figure 3-17: Comparative Severity Ranking of EBV .................................................... 70

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Figure 3-18: Comparative Severity Ranking of ETEC ................................................. 72

Figure 3-19: Comparative Severity Ranking of Heart Attack ...................................... 75
Figure 3-20: Comparative Severity Ranking of H. Pylori Infection............................. 78
Figure 3-21: Comparative Severity Ranking of Hepatitis C and E .............................. 81
Figure 3-22: Comparative Severity Ranking of Herpesvirus Infection ....................... 84
Figure 3-23: Comparative Severity Ranking of Hookworm ......................................... 86
Figure 3-24Comparative Severity Ranking of Hypertension ........................................ 88
Figure 3-25: Comparative Severity Ranking of HIV/AIDS .......................................... 91
Figure 3-26: Comparative Severity Ranking of Leishmaniasis .................................... 96
Figure 3-27: Comparative Severity Ranking of Malaria............................................... 98
Figure 3-28: Comparative Severity Ranking of MRSA Infection .............................. 101
Figure 3-29: Comparative Severity Ranking of Multiple Sclerosis ............................ 104
Figure 3-30: Comparative Severity Ranking of Obesity ............................................. 107
Figure 3-31: Comparative Severity Ranking of PIV-3 Infection ................................ 111
Figure 3-32: Comparative Severity Ranking of Parkinsons Disease ........................ 113
Figure 3-33: Comparative Severity Ranking of Plague ............................................... 115
Figure 3-34: Comparative Severity Ranking of RSV Infection .................................. 116
Figure 3-35: Comparative Severity Ranking of Ross River Virus Infection ............. 118
Figure 3-36: Comparative Severity Ranking of Shigellosis......................................... 120
Figure 3-37: Comparative Severity Ranking of Stroke ............................................... 123
Figure 3-38: Comparative Severity Ranking of Tuberculosis .................................... 125
Figure 3-39: Comparative Severity Ranking of West Nile Virus Infection ............... 129

CHAPTER FOUR: MARKET ANALYSIS

Table 4-1:World Market for Emerging Vaccines by Type, 2011 ............................... 133
Table 4-2: World Market for Emerging Vaccines by Type, 2011-2021 ..................... 136
Table 4-3: World Acne Vaccine Market 2011-2021 ..................................................... 138
Table 4-4: World Addiction Vaccine Market 2011-2021............................................. 139
Table 4-5: World Allergy Vaccine Market 2011-2021 ................................................. 141
Table 4-6: World Alzheimers Disease Vaccine Market 2011-2021 ........................... 142
Table 4-7: World Anthrax Vaccine Market 2011-2021 ............................................... 144
Table 4-8: World Asthma Vaccine Market 2011-2021 ................................................ 145
Table 4-9: World Campylobacter Vaccine Market 2011-2021 ................................... 146
Table 4-10: World Celiac Disease Vaccine Market 2011-2021 ................................... 147
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Table 4-11: World Chlamydia Vaccine Market 2011-2021......................................... 149

Table 4-12: World Croup Vaccine Market 2011-2021 ................................................ 150
Table 4-13: World Cytomegalovirus Vaccine Market 2011-2021 .............................. 151
Table 4-14: World Dengue Fever Vaccine Market 2011-2021 .................................... 152
Table 4-15: World Diabetes Vaccine Market 2011-2021 ............................................. 154
Table 4-16: World Ebola Vaccine Market 2011-2021 ................................................. 155
Table 4-17: World EBV Vaccine Market 2011-2021 ................................................... 156
Table 4-18: World ETEC Vaccine Market 2011-2021................................................. 158
Table 4-19: World Heart Attack Vaccine Market 2011-2021 ..................................... 160
Table 4-20: World H. Pylori Vaccine Market 2011-2021 ............................................ 161
Table 4-21: World Hepatitis C & E Vaccine Market 2011-2021 ................................ 162
Table 4-22: World Herpesvirus Vaccine Market 2011-2021....................................... 163
Table 4-23: World Hookworm Vaccine Market 2011-2021 ........................................ 165
Table 4-24: World Hypertension Vaccine Market 2011-2021 .................................... 167
Table 4-25: World HIV/AIDS Vaccine Market 2011-2021 ......................................... 168
Table 4-26: World Leishmaniasis Vaccine Market 2011-2021 ................................... 169
Table 4-27: World Malaria Vaccine Market 2011-2021 .............................................. 170
Table 4-28: World MRSA Vaccine Market 2011-2021 ................................................ 172
Table 4-29: World Multiple Sclerosis Vaccine Market 2011-2021 ............................. 173
Table 4-30: World Obesity Vaccine Market 2011-2021 .............................................. 175
Table 4-31: World PIV-3 Vaccine Market 2011-2021 ................................................. 176
Table 4-32: World Parkinsons Disease Vaccine Market 2011-2021 ......................... 177
Table 4-33: World Plague Vaccine Market 2011-2021 ................................................ 178
Table 4-34: World RSV Vaccine Market 2011-2021 ................................................... 179
Table 4-35: World Ross River Virus Vaccine Market 2011-2021 .............................. 181
Table 4-36: World Shigellosis Vaccine Market 2011-2021 .......................................... 182
Table 4-37: World Stroke Vaccine Market 2011-2021 ................................................ 184
Table 4-38: World Tuberculosis Vaccine Market 2011-2021...................................... 185
Table 4-39: World West Nile Virus Vaccine Market 2011-2021 ................................ 186

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Two: Introduction
10

into host cells. Once inside the cell, viral DNA assumes control of the cell, instructing it
to produce specific types of proteins. Vaccines are produced by culturing bacteria or
viruses under conditions that lead to a loss of virulence, but not the ability to provoke an
antigenic response. Other vaccines are created from specially treated toxins or dead
bacteria that are still antigenic.
It typically takes several days for the immune system to mount a sufficiently
strong response to conquer invading organisms; sometimes, this latent period is enough
time for the virus or bacteria to cause disease. If, however, the immune system has been
previously presented with low doses of the antigen, such as the subvirulent doses
introduced by vaccines, the response is much faster and stronger. When the more potent,
virulent version of the organism subsequently invades, the immune system conquers the
disease before it takes hold.
Vaccines cause long-lasting effects (months or even years) against viral diseases
by stimulating the immune response to form antibodies against the disease. They often
require 2 to 10 days for full protection to be achieved, but the immune response may be
stimulated by repeated doses (booster shots) delivered after an initial inoculation.

TYPES OF VACCINES
As shown in Table 2-2, there are more than two dozen vaccine-preventable
diseases for which vaccines have been formulated. Of these vaccines, four different types
are currently available:

Attenuated (weakened) live viruses;

Killed (inactivated) viruses or bacteria;

Toxoid vaccines contain a toxin produced by the bacterium;

Genetically engineered/modified vaccines;

Bacteria-based vaccines.
Attenuated (Weakened) Live Viruses

Attenuated viruses consist of live micro-organisms that have been cultivated

under conditions which disable their virulent properties. They typically provoke more
durable immunological responses and are therefore the preferred type of vaccine for
healthy adults. Jenners cowpox vaccine represented the first use of a live, attenuated
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Three: Emerging Vaccines

37

of detoxification followed by a long period of psycho-social therapy. Some medications

such as Reckitt Benckisers Suboxone (buprenorphine and naloxone) may be prescribed
to curb physical cravings, however many drug abuse specialists prefer not to use these
aids as they do not address psychological cravings and prescriptions are often re-sold by
drug addicts to fund their addiction. (Suboxone has a street value among recovering
addicts who are unable to obtain prescriptions).
Methadone is another option for persons with opiate addictions as it would curb
physical cravings; however, methadone is typically reserved for those with the most
severe addictions as its usage is associated with a range of practical problems including a
high likehood of patients becoming addicted to methadone, the need for patients to utilize
methadone for long period of time that can reach one to two years or more, and the
necessity for patients to report daily to specially licensed methadone clinics ro receive the
drug. Most clinics are located in low rent urban areas, discouraging many middle class
drug users from taking advantage of this option so that as of mid 2012, methadone
remained an option of last resort for most opiate addicts.
While a vaccine for addiction would work in a similar manner as these
medications that is, it would not reverse a hereditary disposition towards drugs and
alcohol but could potentially keep drugs that enter the body from reaching the brain thus
preventing the high from being experienced it would offer an advantage over a daily
medication as it could not be re-sold by addicts. However, work in this area is limited
since the potential return on an addiction vaccine, which would be used by a relatively
small portion of the population compared with a prophylactic vaccine that would be
administered universally, is quite limited compared with the return on an anti-addiction
drug that would be taken chronically. For this reason, pharmaceutical investment in this
area is relatively low and most research is government sponsored.
Nonetheless, there have been some promising developments. In April 2006, the
FDA approved Vivitrol (naltrexone extended release injectable suspension), a product
produced by Alkermes. Vivitrol was the first injectable drug given once per month to
treat alcohol dependence, and is indicated for alcohol-dependent persons who are able to
abstain from drinking in an outpatient setting and are not actively drinking when starting
treatment. It is also intended for use in combination with psychosocial support, such as
counseling or group therapy. In 2010, the FDA approved Vivitrol for treatment of opoid
addiction, after studies involving heroin users showed an XX% quit rate at the end of six
month. Because Vivitrol does not create antibodies, however, it is not considered a
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Four: Market Analysis

133

Table 4-1

World Market for Emerging Vaccines by Type, 2011-2021

(Revenue in $ millions)

Year

2011

2012

Best Case
Likely Case
Worst Case

Source: Kalorama Information

2013

Expected Market Entry of Compounds Under Development:

Phase III
Phase II
Phase I
2014
2015
2016
2017
2018
2019

Pre-clinical
2020
2021