Abstract
Attitudes towards vaccination are changing, as the promise grows of candidate
products in development which have the potential to prevent and treat some of
the major diseases affecting the world' s population today. Immunisation, the
World Health Organization argues, has proved itself: smallpox was eradicated
worldwide in the late 1970s, Europe was declared free of polio at the turn of
the 21st century and, in 2002 alone, an estimated two million lives were saved
by immunisation. Years of disappointment, with vaccines for unmet needs
failing in Phases II and III, are ending as new vaccines begin to reach the
market and more advance through the pipeline.
In 2007, pre-teenage and teenage girls are being vaccinated against HPV, a
known and common cause of cervical cancer, the second-largest cancer killer of
women. In the next few years, approval is expected for vaccinations against
other forms of cancer, including prostate, colon and lung cancers. There are
also advanced candidates for influenza, malaria, tuberculosis, hepatitis B and
HIV. Vaccines for rotavirus and meningitis A, diseases that kill vast numbers
of children in the developing world each year, may not be far off and their
development is being supported by public and private funding, in addition to
fast-tracking rulings. Innovation by small biotechnology companies,
financially and commercially supported by strategic alliances with the largest
pharmaceutical companies, has led to the development of the therapeutic
vaccine, which has the potential to treat rather than prevent disease and has
given new hope to the sufferers of cancer, CNS disorders, autoimmune
conditions and asthma, even addiction.
The largest section of the vaccination market is paediatric immunisation. Six
vaccines are routinely given to children as part of their infant immunisation
- these comprise vaccines against tuberculosis (BCG), diphtheria, tetanus,
pertussis, polio (OPV) and measles. However, not all children receive these
immunisations and in some developed countries the number of children being
vaccinated is dropping. These problems must be redressed in order to prevent
the 30,000 deaths which are estimated to take place each day from entirely
vaccine-preventable diseases. Other, newer vaccines are also available and
need to be more widely used, including vaccines against yellow fever, rubella,
hepatitis B, Haemophilus influenzae type B (Hib) disease and Japanese
encephalitis.
Adult vaccination is on the increase and now growing at a faster pace than
paediatric immunisations. This is largely because of the recent emphasis
placed on immunisation against influenza and hepatitis. Children will benefit
from the development of new combination products while everyone will reap the
benefits of alternative routes of delivery to needles.
Table of Contents
CHAPTER 1 INTRODUCTION
- 1.1 Vaccines
- 1.1.1 General
- 1.1.2 A brief history
- 1.2 The immune system
- 1.2.1 Introduction
- 1.2.2 MCH markers
- 1.2.3 Lymphocytes
- 1.2.4 B cells and T cells
- 1.2.5 Cytokines and chemokines
- 1.2.6 Phagocytes and granulocytes
- 1.2.7 Complement proteins
- 1.2.8 When the immune system fails
- 1.3 Immunological aspects of cancer
- 1.3.1 Introduction
- 1.3.2 The development of a tumour
- 1.3.3 The treatment of cancer
- 1.4 Immunisation
- 1.5 Types of vaccine
- 1.5.1 Prophylactic vaccines
- 1.5.2 Therapeutic vaccines
- 1.5.3 Recombinant vaccines
- 1.5.4 DNA vaccines
- 1.5.5 Autologous and allogenic vaccines
- 1.5.6 Attenuated live vaccines
- 1.5.7 Inactivated killed vaccines
CHAPTER 2 THE VACCINES MARKET
- 2.1 The vaccines market today
- 2.2 The potential for change
- 2.3 Market size
- 2.4 Major players
- 2.4.1 GlaxoSmithKline (GSK)
- 2.4.1.1 Company background
- 2.4.1.2 Products
- 2.4.1.3 Cervarix
- 2.4.1.4 Other cancer candidates
- 2.4.1.5 Other products in the pipeline
- 2.4.2 Merck & Co
- 2.4.2.1 Company background
- 2.4.2.2 Gardasil
- 2.4.2.3 Other launched products
- 2.4.2.4 Products in the pipeline
- 2.4.3 Novartis
- 2.4.3.1 Company background
- 2.4.3.2 Novartis' influenza vaccine pipeline
- 2.4.3.3 Other products in the pipeline
- 2.4.4 Sanofi-Aventis
- 2.4.4.1 Company background
- 2.4.4.2 Cancer vaccine products
- 2.4.4.3 Other vaccine products
- 2.4.5 Wyeth
- 2.4.5.1 Company background
- 2.4.5.2 Launched products
- 2.4.5.3 Products in the pipeline
- 2.5 The importance of cancer vaccines in the overall market
- 2.6 Marketed cancer vaccines
- 2.6.1 Cervarix - GlaxoSmithKline
- 2.6.2 Gardasil - Merck & Co
- 2.6.3 M-Vax - AVAX Technologies
- 2.6.4 TheraCys - Sanofi Pasteur
- 2.6.5 Bacillus Calmette-Guerin (BCG) vaccine - GSK
- 2.6.6 Melacine - GSK
- 2.7 Other marketed vaccines
- 2.7.1 Combination vaccinations
- 2.7.2 Hepatitis B
- 2.7.3 Hepatitis A
- 2.7.4 Influenza
- 2.7.4.1 FluMist - Aviron (now AstraZeneca)
- 2.7.4.2 Fluviron/Flu-Immune - Powderject Pharmaceuticals (now Novartis)
- 2.7.4.3 Fluviral - ID Biomedical (now GSK)
- 2.7.4.4 Fluzone - Sanofi Pasteur
- 2.7.4.5 Inflexal V and Nasalflu - Crucell
- 2.7.4.6 LAIV - The Institute of Experimental Medicine, St Petersburg,
Russia
- 2.7.4.7 Other marketed influenza vaccines
- 2.7.5 Haemophilus influenzae type B (HiB)
- 2.7.6 Pertussis
- 2.7.7 Rabies
- 2.7.8 Typhoid
- 2.7.9 Varicella and zoster
- 2.7.10 Meningitis
- 2.7.10.1 Meningitis (non-specific)
- 2.7.10.2 Meningitis A
- 2.7.10.3 Meningitis B
- 2.7.10.4 Meningitis B/C
- 2.7.10.5 Meningitis C
- 2.7.11 Pneumococcus
- 2.7.12 Poliomyelitis
- 2.7.13 MMR and measles and rubella
- 2.7.14 Smallpox
- 2.7.15 Other indications
- 2.7.15.1 Cholera
- 2.7.15.2 Rotavirus
- 2.7.15.3 Epidemic haemorrhagic fever
- 2.7.15.4 Japanese encephalitis (JE)
- 2.7.15.5 Lactobacillus
- 2.7.15.6 Yellow fever
- 2.7.15.7 Tick borne encephalitis (TBE)
- 2.7.15.8 Q fever
- 2.7.15.9 Ribosomal vaccine
- 2.7.15.10 Urinary infection
- 2.7.16 Launched therapeutic vaccines
- 2.7.16.1 Leprovac
- 2.7.16.2 Fluarix
- 2.7.16.3 SolcoTrichovac
- 2.7.16.4 PCEC
- 2.7.17 Withdrawn vaccines
CHAPTER 3 CHALLENGES AND OPPORTUNITIES
- 3.1 Introduction
- 3.2 Unmet needs
- 3.2.1 Cancer
- 3.2.2 HIV/AIDS
- 3.2.3 Autoimmune diseases
- 3.2.3.1 Asthma
- 3.2.3.2 Diabetes mellitus (type 1)
- 3.2.3.3 Rheumatoid arthritis (RA)
- 3.2.4 Infectious disease
- 3.2.4.1 Tuberculosis (TB)
- 3.2.4.2 Meningitis
- 3.2.5 Malaria
- 3.2.6 Bioterrorism threat
- 3.2.7 Addiction
- 3.2.8 Hepatitis C (HCV)
- 3.2.9 CNS - Alzheimer' s disease
- 3.3 Technical challenges
- 3.3.1 Alternatives to egg-grown vaccines
- 3.3.2 Alternatives to needles
- 3.3.3 Problems with supply and storage of vaccines
- 3.3.4 Reducing the number of vaccinations
- 3.4 Commercial challenges
- 3.4.1 Research and development
- 3.4.2 Economies of scale
- 3.4.3 Public opinion
CHAPTER 4 VACCINES IN DEVELOPMENT
- 4.1 Cancer
- 4.1.1 Introduction
- 4.1.2 Registered or awaiting approval
- 4.1.3 Cancer vaccines in Phase III clinical development
- 4.1.3.1 Brain cancer
- 4.1.3.2 HPV
- 4.1.3.3 Lung cancer and nsclc
- 4.1.3.4 Lymphoma
- 4.1.3.5 Pancreas cancer
- 4.1.3.6 Prostate cancer
- 4.1.3.7 Renal cancer
- 4.1.4 Cancer vaccines in Phase II clinical development
- 4.1.4.1 General
- 4.1.4.2 Brain cancer
- 4.1.4.3 Breast cancer
- 4.1.4.4 Cervical cancer
- 4.1.4.5 Colorectal cancer
- 4.1.4.6 Leukaemia
- 4.1.4.7 Lung cancer and nsclc
- 4.1.4.8 Lymphoma
- 4.1.4.9 Melanoma
- 4.1.4.10 Myeloma
- 4.1.4.11 Prostate cancer
- 4.1.4.12 Renal cancer
- 4.1.5 Cancer vaccines in Phase I clinical development
- 4.1.5.1 Multiple or unspecified targets
- 4.1.5.2 Bladder cancer
- 4.1.5.3 Brain cancer
- 4.1.5.4 Breast cancer
- 4.1.5.5 Head and neck cancer
- 4.1.5.6 Liver cancer
- 4.1.5.7 Lung and nsclc cancer
- 4.1.5.8 Oesophageal cancer
- 4.1.5.9 Ovarian and pancreatic cancers
- 4.1.5.10 Prostate cancer
- 4.1.6 Cancer vaccines in preclinical development
- 4.1.6.1 Non-specified cancers
- 4.1.6.2 General cancer targets
- 4.1.6.3 Bone cancer
- 4.1.6.4 Breast cancer
- 4.1.6.5 Colorectal and colon cancer
- 4.1.6.6 Gastric cancer
- 4.1.6.7 HPV
- 4.1.6.8 Leukaemia
- 4.1.6.9 Liver cancer
- 4.1.6.10 Lung cancer and nsclc
- 4.1.6.11 Melanoma
- 4.1.6.12 Myeloma
- 4.1.6.13 Ovarian cancer
- 4.1.6.14 Pancreatic cancer
- 4.1.6.15 Prostate cancer
- 4.1.6.16 Renal cancer
- 4.2 Infectious diseases
- 4.2.1 AIDS/HIV
- 4.2.1.1 The Aaron Diamond AIDS Research Center
- 4.2.1.2 Alphavax
- 4.2.1.3 Avant Immunotherapeutics
- 4.2.1.4 Bavarian Nordic
- 4.2.1.5 Bionor Immuno
- 4.2.1.6 Cytrx
- 4.2.1.7 Dong-A
- 4.2.1.8 EuroVac
- 4.2.1.9 FIT Biotech
- 4.2.1.10 Genecure
- 4.2.1.11 Genetic Immunity
- 4.2.1.12 Geovax
- 4.2.1.13 GlaxoSmithKline
- 4.2.1.14 Immunitor
- 4.2.1.15 Merck & Co
- 4.2.1.16 Neovacs
- 4.2.1.17 Novartis
- 4.2.1.18 Oxford Biomedica
- 4.2.1.19 Pharmexa
- 4.2.1.20 Powdermed
- 4.2.1.21 Sanofi-Aventis
- 4.2.1.22 St Jude' s Hospital, Memphis
- 4.2.1.23 Targeted Genetics
- 4.2.1.24 Therion Biologics
- 4.2.1.25 The Vaccine Research Center (VRC)
- 4.2.1.26 Vaxgen
- 4.2.1.27 Vical
- 4.2.1.28 Virax
- 4.2.1.29 Virionics
- 4.2.1.30 Wyeth
- 4.2.1.31 Non-industry collaborations
- 4.2.2 Hepatitis (excluding paediatric combination vaccines)
- 4.2.2.1 Hepatitis B (HBV)
- 4.2.2.2 Hepatitis C (HCV)
- 4.2.2.3 Hepatitis E
- 4.2.3 Influenza
- 4.2.3.1 Acambis
- 4.2.3.2 Alphavax
- 4.2.3.3 Baxter
- 4.2.3.4 Crucell
- 4.2.3.5 CSL
- 4.2.3.6 Dynport Vaccine Company
- 4.2.3.7 Generex
- 4.2.3.8 GlaxoSmithKline
- 4.2.3.9 Iomai
- 4.2.3.10 Medimmune
- 4.2.3.11 Merck & Co
- 4.2.3.12 Nasvax
- 4.2.3.13 Novartis
- 4.2.3.14 Novavax
- 4.2.3.15 Powdermed
- 4.2.3.16 Protein Sciences
- 4.2.3.17 Sanofi-Aventis
- 4.2.3.18 Sinovac Biotech
- 4.2.3.19 Solvay
- 4.2.4 Malaria
- 4.2.5 Meningitis and pneumococcal infection
- 4.2.5.1 China Biopharma
- 4.2.5.2 Emergent Biosolutions
- 4.2.5.3 GlaxoSmithKline
- 4.2.5.4 LG Life Sciences
- 4.2.5.5 Novartis
- 4.2.5.6 Sanofi-Aventis
- 4.2.5.7 Wyeth
- 4.2.6 Tuberculosis
- 4.2.7 Other infectious diseases
- 4.2.7.1 Cholera
- 4.2.7.2 Dengue fever
- 4.2.7.3 Ebola and Marburg infections
- 4.2.7.4 Helicobacter pylori
- 4.2.7.5 Japanese encephalitis
- 4.2.7.6 Rabies
- 4.2.7.7 Rotavirus
- 4.2.7.8 Typhoid fever
- 4.2.7.9 West Nile virus infection
- 4.2.7.10 Yellow fever
- 4.3 Other indications
- 4.3.1 Addiction
- 4.3.2 Allergy and asthma
- 4.3.3 Autoimmune diseases
- 4.3.3.1 Diabetes
- 4.3.3.2 Rheumatoid arthritis (RA)
- 4.3.4 Bioterrorist threats
- 4.3.4.1 Anthrax
- 4.3.4.2 Botulinum
- 4.3.4.3 Plague
- 4.3.4.4 Smallpox
- 4.3.5 Alzheimer' s disease
- 4.3.6 Obesity
CHAPTER 5 COMPANY PROFILES
- 5.1 Introduction
- 5.2 Æterna Zentaris
- 5.2.1 Company overview
- 5.2.2 Financial data
- 5.2.3 Products
- 5.2.4 R&D portfolio
- 5.3 Argos Therapeutics
- 5.3.1 Company overview
- 5.3.2 Financial data
- 5.3.3 Products
- 5.3.4 R&D portfolio
- 5.4 Avant Immunotherapeutics
- 5.4.1 Company overview
- 5.4.2 Financial data
- 5.4.3 Products
- 5.4.4 R&D portfolio
- 5.5 AVAX TECHNOLOGIES
- 5.5.1 Company overview
- 5.5.2 Financial data
- 5.5.3 Products
- 5.5.4 R&D portfolio
- 5.6 BT Pharma
- 5.6.1 Company overview
- 5.6.2 Financial data
- 5.6.3 Products
- 5.6.4 R&D portfolio
- 5.7 Bavarian Nordic
- 5.7.1 Company overview
- 5.7.2 Financial data
- 5.7.3 R&D portfolio
- 5.8 Baxter International
- 5.8.1 Company overview
- 5.8.2 Financial data
- 5.8.3 Products
- 5.8.4 R&D portfolio
- 5.9 Cancer Research Technology
- 5.9.1 Company overview
- 5.9.2 Financial data
- 5.9.3 Products
- 5.9.4 R&D portfolio
- 5.10 Cell Genesys
- 5.10.1 Company overview
- 5.10.2 Financial data
- 5.10.3 Products
- 5.10.4 R&D portfolio
- 5.11 Cellgenix Technologie Transfer
- 5.11.1 Company overview
- 5.11.2 Financial data
- 5.11.3 Products
- 5.11.4 R&D portfolio
- 5.12 Celtic Pharma
- 5.12.1 Company overview
- 5.12.2 Financial data
- 5.12.3 Products
- 5.12.4 R&D portfolio
- 5.13 Crucell
- 5.13.1 Company overview
- 5.13.2 Financial data
- 5.13.3 Products
- 5.13.4 R&D portfolio
- 5.14 CSL
- 5.14.1 Company overview
- 5.14.2 Financial data
- 5.14.3 Products
- 5.14.4 R&D portfolio
- 5.15 Cytos Biotechnology
- 5.15.1 Company overview
- 5.15.2 Financial data
- 5.15.3 Products
- 5.15.4 R&D portfolio
- 5.16 Dendreon
- 5.16.1 Company overview
- 5.16.2 Financial data
- 5.16.3 Products
- 5.16.4 R&D portfolio
- 5.17 FIT Biotech
- 5.17.1 Company overview
- 5.17.2 Financial data
- 5.17.3 Products
- 5.17.4 R&D portfolio
- 5.18 Generex
- 5.18.1 Company overview
- 5.18.2 Financial data
- 5.18.3 Products
- 5.18.4 R&D portfolio
- 5.19 Geron
- 5.19.1 Company overview
- 5.19.2 Financial data
- 5.19.3 Products
- 5.19.4 R&D portfolio
- 5.20 Immunocellular Therapeutics
- 5.20.1 Company overview
- 5.20.2 Financial data
- 5.20.3 Products
- 5.20.4 R&D portfolio
- 5.21 Immunofrontier
- 5.21.1 Company overview
- 5.21.2 Financial data
- 5.21.3 Products
- 5.21.4 R&D portfolio
- 5.22 Immunomedics
- 5.22.1 Company overview
- 5.22.2 Financial data
- 5.22.3 Products
- 5.22.4 R&D portfolio
- 5.23 Immunotope
- 5.23.1 Company overview
- 5.23.2 Financial data
- 5.23.3 Products
- 5.23.4 R&D portfolio
- 5.24 Immvarx
- 5.24.1 Company overview
- 5.24.2 Financial data
- 5.24.3 Products
- 5.24.4 R&D portfolio
- 5.25 Juvaris Biotherapeutics
- 5.25.1 Company overview
- 5.25.2 Financial data
- 5.25.3 Products
- 5.25.4 R&D portfolio
- 5.26 Molmed
- 5.26.1 Company overview
- 5.26.2 Financial data
- 5.26.3 Products
- 5.26.4 R&D portfolio
- 5.27 Mologen
- 5.27.1 Company overview
- 5.27.2 Financial data
- 5.27.3 Products
- 5.27.4 R&D portfolio
- 5.28 Neovacs
- 5.28.1 Company overview
- 5.28.2 Financial data
- 5.28.3 Products
- 5.28.4 R&D portfolio
- 5.29 Newlink Genetics
- 5.29.1 Company overview
- 5.29.2 Financial data
- 5.29.3 Products
- 5.29.4 R&D portfolio
- 5.30 Oxford Biomedica
- 5.30.1 Company overview
- 5.30.2 Financial data
- 5.30.3 Products
- 5.30.4 R&D portfolio
- 5.31 Pepscan Systems
- 5.31.1 Company overview
- 5.31.2 Financial data
- 5.31.3 Products
- 5.31.4 R&D portfolio
- 5.32 Progenics Pharmaceuticals
- 5.32.1 Company overview
- 5.32.2 Financial data
- 5.32.3 Products
- 5.32.4 R&D portfolio
- 5.33 Targepeutics
- 5.33.1 Company overview
- 5.33.2 Financial data
- 5.33.3 Products
- 5.33.4 R&D portfolio
- 5.34 Therion Biologies
- 5.34.1 Company overview
- 5.34.2 Financial data
- 5.34.3 Products
- 5.34.4 R&D portfolio
- 5.35 Vaxon Biotech
- 5.35.1 Company overview
- 5.35.2 Financial data
- 5.35.3 Products
- 5.35.4 R&D portfolio
- 5.36 Virionics
- 5.36.1 Company overview
- 5.36.2 Financial data
- 5.36.3 Products
- 5.36.4 R&D portfolio
LIST OF TABLES
- Table 1.1 Global deaths by cancer type
- Table 1.2 Reduction in diseases in Europe between 1998 and 2004
- Table 2.1 Launched vaccines currently available by indication
- Table 5.1 Financial data for Æterna Zentaris
- Table 5.2 Financial data for Avant Immunotherapeutics 2003-2006 (US$
million)
- Table 5.3 Financial data for AVAX Technologies (US$ million)
- Table 5.4 Financial data for Bavarian Nordic 2003-2006 (DKr million)
- Table 5.5 Financial data for Baxter International 2003-2006 (US$ million)
- Table 5.6 Financial data for Cell Genesys 2002-2006 (US$ million)
- Table 5.7 Financial data for Crucell (€ million)
- Table 5.8 Financial data for CSL 2002-2006 (AUS$ million)
- Table 5.9 Financial data for Cytos Biotechnology 2002-2006 (SwFr million)
- Table 5.10 Financial data for Dendreon 2002-2006 (US$ million)
- Table 5.11 Financial data for Generex 2002-2006 (US$ million)
- Table 5.12 Financial data for Geron 2002-2006 (US$ million)
- Table 5.13 Financial data for ICT (US$ million)
- Table 5.14 Financial data for Immunomedics 2002-2006 (US$ million)
- Table 5.15 Financial data for Mologen (€ million)
- Table 5.16 Financial data for Oxford Biomedica 2002-2006 (£ million)
- Table 5.17 Financial data for Progenics Pharmaceuticals 2003-2006 (US$
million)
LIST OF FIGURES
- Figure 1.1 Trends in the vaccine industry
- Figure 1.2 Trends in the development of prophylactic vaccines
- Figure 1.3 Trends in the development of therapeutic vaccines
- Figure 1.4 Trends in the development of recombinant vaccines
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