Therapeutic Vaccines: Targets, Technologies and Markets

TABLE OF CONTENTS

INTRODUCTION

STUDY GOAL AND OBJECTIVES
• REASONS FOR DOING THE STUDY
• CONTRIBUTIONS OF THE STUDY AND FOR WHOM
• SCOPE AND FORMAT
• METHODOLOGY
• INFORMATION SOURCES
• RELATED BCC WORK CREDENTIALS INCLUDING WORK DONE BY OTHER AUTHORS
• BCC ON-LINE SERVICES
• DISCLAIMER

EXECUTIVE SUMMARY

Summary Table:
THE WORLDWIDE MARKET FOR THERAPEUTIC VACCINES BY INDICATION, THROUGH 2010 ($ MILLIONS)
• Summary Figure:
  THE WORLDWIDE MARKET FOR THERAPEUTIC VACCINES BY INDICATION, 2003-2010

OVERVIEW

DEFINITION OF A THERAPEUTIC VACCINE
• IMMUNE SYSTEM OVERVIEW: CAST OF CHARACTERS
  B-CELLS, T-CELLS AND ANTIGEN-PRESENTING CELLS
  B-Cells
  T-Cells
  Antigen-Presenting Cells
• CELLULAR VS. HUMORAL IMMUNITY
• INNOVATIVE APPROACHES TO VACCINE TECHNOLOGY
  DNA VACCINES
  • CARBOHYDRATE VACCINES
    Therapeutic Cancer Vaccines
    Therapeutic AIDS Vaccines
• ADJUVANTS
• STATISTICAL POWER AND WHAT IT MEANS IN CLINICAL TRIALS
• THE FDA MODERNIZATION ACT OF 1997
  FAST TRACK STATUS
  • SPECIAL PROTOCOL ASSESSMENT

PRODUCTS

ADDICTION VACCINES
• Table 1 THE WORLDWIDE MARKET FOR ADDICTION VACCINES BY TYPE OF ADDICTION, THROUGH 2010 ($ MILLIONS)
  COCAINE ADDICTION VACCINES
  The Market for Cocaine Addiction Vaccines
• Table 2 THE WORLDWIDE MARKET FOR COCAINE ADDICTION VACCINES: THROUGH 2010 ($ MILLIONS)
  TA-CD
  • NICOTINE ADDICTION VACCINES
    The Market for Nicotine Addiction Vaccines
• Table 3 THE WORLDWIDE MARKET FOR NICOTINE ADDICTION VACCINES: THROUGH 2010 ($ MILLIONS)
  Cytos Vaccine
  NicVAX
  TA-NIC
  Prommune Vaccine
  • PROPHYLACTIC ADDICTION VACCINES
  • AUTOIMMUNE DISEASE VACCINES
    DIABETES VACCINE AND IMMUNOTHERAPY RESEARCH COORDINATING CENTRE
    • DIAMYD MEDICAL
    • STANFORD MEDICAL CENTER
      Stanford Medical Center (Continued)
    • TECHNION-ISRAEL INSTITUTE
    • UNIVERSITY OF BRISTOL
  • CANCER VACCINES
    CANCER STATISTICS
    U.S. Cancer Statistics
• Table 4 INCIDENCE, MORTALITY, AND SURVIVAL RATES FOR COMMON CANCERS IN THE U.S., 2003
• Table 5 CANCER PREVALENCE RATES IN THE U.S., 2003
• Table 5 (CONTINUED)
• Table 6 ANNUAL INCIDENCE OF, AND DEATH RATES FOR CANCERS FOR WHICH THERAPEUTIC VACCINES ARE IN DEVELOPMENT IN THE U.S., 2003
  Current Treatment Methods
  Surgery
  Radiation Therapy
  Pharmaceutical Therapy
  Prophylactic Vaccine for Hepatitis B
  Cancers for Which Vaccines Are in Phase II or Later Development
  Bladder Cancer
  Breast Cancer
  Cervical Cancer
  Colorectal Cancer
  Esophageal and Gastric Cancer
  Lung Cancer
  Melanoma
  Multiple Myeloma
  Myelogenous Leukemia
  Non-Hodgkins Lymphoma
  Pancreatic Cancer
  Prostate Cancer
  Renal Cell Carcinoma
  • CANCER VACCINES: A NEW MODALITY OF CARE
    The Primary Therapeutic Role for Cancer Vaccines
    The Immune System and Cancer
    Antigens: Their Role in Cancer Vaccines
    Antigens Used in Cancer Vaccine Development
    Carcinoembryonic Antigen
    Ganglioside Molecules
    Heat Shock Proteins
    MART-1
    Prostate-Specific Antigen
    Sialyl Tn
    Tyrosinase
    Vaccine Development: Strategies
    Vaccine Development: Strategies (Continued)
    A Summary of Two Approaches: Low-technology vs. High-technology
    Vaccine Types
    Antigen/Adjuvant Vaccines
    Dendritic Cell Vaccines (DCs)
    DNA and Viral Vector Vaccines
    Idiotype Vaccines
    Oncolytic Virus Vaccines
    Whole Cell Tumor Vaccines
• Table 7 TYPES OF VACCINES IN DEVELOPMENT FOR CANCER TREATMENT
  The Long Road to Market
  The Market for Cancer Vaccines
• Table 8 ESTIMATED U.S. MARKET FOR CANCER VACCINES BY INDICATION
• Table 9 WORLDWIDE MARKET FOR CANCER VACCINES BY TYPE, THROUGH 2010 ($ MILLIONS)
• Table 9 (CONTINUED)
• Table 10 THE MARKET FOR CANCER VACCINES, BY TECHNOLOGY (AUTOLOGOUS VERSUS ALLOGENEIC), WORLDWIDE, THROUGH 2010 ($ MILLIONS)
• Figure 1 PERCENTAGE OF THE MARKET HELD BY AUTOLOGOUS VERSUS ALLOGENEIC CANCER VACCINES, WORLDWIDE, 2005 AND 2010 (%)
• Table 11 THE WORLDWIDE MARKET FOR CANCER VACCINES, BY INDICATION, THROUGH 2010 ($ MILLIONS)
• Figure 2 THERAPEUTIC CANCER VACCINE MARKET SHARE BY COMPANY, 2004 AND 2010 (%)
  CANCER VACCINES IN DEVELOPMENT
• Table 12 CANCER VACCINES IN PHASE II OR LATER TRIALS
• Table 12 (CONTINUED)
• Table 12 (CONTINUED)
• Table 12 (CONTINUED)
• Table 12 (CONTINUED)
• Table 12 (CONTINUED)
  CANCER VACCINES ON THE WORLDWIDE MARKET
  Melacine
  Oncovax
  • CANCER VACCINES IN DEVELOPMENT
    AG-858
    Allovectin-7
    Alvac-CEA/B7.1
    Avicine
    BEC2
    Biovaxid
    BLP25
    Canvaxin
    Canvaxin (Continued)
    CeaVac
    Cervarix
    CG7870
    Collidem
    Colorectal Cancer Vaccine
    DCVax-Brain
    Eladem
    EP-2101
    FavId
    GMK
    GnRH Pharmaccine
    GVAX Vaccines
    GVAX Leukemia Vaccine
    GVAX Lung Cancer Vaccine
    GVAX Myeloma Vaccine
    GVAX Pancreatic Cancer Vaccine
    GVAX Prostate Cancer Vaccine
    GVAX Prostate�Econtinued)
    IGN101
    Insegia
    Insegia (Continued)
    Lung Cancer Vaccines
    M-Vax
    MAGE-12: 170-178 Peptide Vaccine
    MART-1/Melan-A
    MDX-1379
    Melacine
    MUC1 Vaccine
    Multivalent Antigen Vaccine
    MVA-HPV-IL2 Vaccine
    MVA-MUC1-IL2 Vaccine
    Mylovenge
    MyVax Personalized Immunotherapy
    Myvax Personalized Immunotherapy (Continued)
    Norelin
    Oncophage
    Oncophage (Continued)
    OncoVax
    Onyvax-P
    PanVac-VF
    Patient-specific Vaccines
    Prostate Cancer Vaccines
    ProstVac-VF
    Provenge
    TA-HPV/TA-CIN
    TVAX Telomerase Therapeutic Vaccine
• Table 13 TELOMERASE EXPRESSION RATES BY CANCER TYPE
  TG4010
  Theratope
  TroVax
  Uvidem
  • HIV/AIDS VACCINES
    THE HIV INFECTION PROCESS
    • HIV TRANSMISSION
    • CONFUSION REGARDING THE PROPHYLACTIC VERSUS THERAPEUTIC ACTIVITY OF AIDS VACCINES
    • BARRIERS TO DEVELOPING AND TESTING AIDS VACCINES
    • AIDSVAX, THE MOST ADVANCED AIDS VACCINE CANDIDATE BUT WITH DISAPPOINTING NEWS
    • WHAT HAS BEEN LEARNED
    • THE MARKET FOR AIDS VACCINES
    • AIDS VACCINES IN DEVELOPMENT
• Table 14 SELECTED HIV AND AIDS VACCINES IN PHASE II OR LATER DEVELOPMENT BY DRUG COMPANIES
• Table 14 (CONTINUED)
  Results of Early Trials of HIV/AIDS Vaccines
  Alvac-HIV
  EP HIV-1090
  IR103
  Merck DNA Vaccine
  Merck/Aventis AIDS Vaccine
  Remune
  Remune (Continued)
  Remune (Continued)
  Bacteria-based Vaccines
  • INFECTIOUS DISEASE VACCINES (OTHER THAN HIV)
  • NEUROLOGICAL DISEASE VACCINES
    THE MARKET FOR NEUROLOGICAL DISEASE VACCINES
    • ALZHEIMERS DISEASE VACCINE
    • MULTIPLE SCLEROSIS VACCINE
    • PARKINSONS DISEASE VACCINE

COMPANY PROFILES

ANTIGENICS INC.
BUSINESS OVERVIEW
• FINANCIAL INFORMATION
• PRODUCTS
• CORPORATE STRATEGY
  Corporate Strategy (Continued)
• APHTON CORPORATION
  BUSINESS OVERVIEW
  • FINANCIAL INFORMATION
  • PRODUCTS
  • CORPORATE STRATEGY
    Corporate Strategy (Continued)
• AVAX TECHNOLOGIES, INC.
  BUSINESS OVERVIEW
  • FINANCIAL INFORMATION
  • PRODUCTS
  • CORPORATE STRATEGY
• AVI BIOPHARMA, INC.
  BUSINESS OVERVIEW
  • FINANCIAL INFORMATION
  • PRODUCTS
• Table 15 AVI BIOPHARMAS PRODUCT PIPELINE
• Table 15 (CONTINUED)
  CORPORATE STRATEGY
  • BIOMIRA INC.
    BUSINESS OVERVIEW
    • FINANCIAL INFORMATION
    • PRODUCTS
      Products (Continued)
    • CORPORATE STRATEGY
      Corporate Strategy (Continued)
  • BIOVEST INTERNATIONAL, INC.
    BUSINESS OVERVIEW
    • PRODUCTS
    • CORPORATE STRATEGY
  • CANCERVAX CORP.
    BUSINESS OVERVIEW
    • FINANCIAL INFORMATION
    • PRODUCTS
• Table 16 CANCERVAXS PRODUCT PIPELINE
  CORPORATE STRATEGY
  Corporate Strategy (Continued)
  • CELL GENESYS, INC.
    BUSINESS OVERVIEW
    • FINANCIAL INFORMATION
    • PRODUCTS
• Table 17 THE CELL GENESYS PRODUCT PIPELINE
  CORPORATE STRATEGY
  • CORIXA CORP.
    BUSINESS OVERVIEW
    • FINANCIAL INFORMATION
    • PRODUCTS
• Table 18 CORIXAS PRODUCT PIPELINE
  CORPORATE STRATEGY
  • DENDREON CORP.
    BUSINESS OVEVIEW
    • FINANCIAL INFORMATION
    • PRODUCTS
• Table 19 DENDREONS PRODUCT PIPELINE
• Table 19 (CONTINUED)
  CORPORATE STRATEGY
  • EPIMMUNE, INC.
    BUSINESS OVERVIEW
    • FINANCIAL INFORMATION
    • PRODUCTS
• Table 20 EPIMMUNES PRODUCT PIPELINE
• Table 20 (CONTINUED)
  CORPORATE STRATEGY
  • FAVRILLE, INC.
    BUSINESS OVERVIEW
    • PRODUCTS
    • CORPORATE STRATEGY
  • GENITOPE CORP.
    BUSINESS OVERVIEW
    • FINANCIAL INFORMATION
    • PRODUCTS
• Table 21 GENITOPES PRODUCT PIPELINE
  CORPORATE STRATEGY
  Corporate Strategy (Continued)
  • GERON CORP.
    BUSINESS OVERVIEW
    • FINANCIAL INFORMATION
    • PRODUCTS
      Products (Continued)
• Table 22 GERONS PRODUCT PIPELINE
  CORPORATE STRATEGY
  • IMCLONE SYSTEMS INC.
    BUSINESS OVERVIEW
    • FINANCIAL INFORMATION
    • LEADING PRODUCT CANDIDATES
    • CORPORATE STRATEGY
  • THE IMMUNE RESPONSE CORP.
    BUSINESS OVERVIEW
    • FINANCIAL INFORMATION
    • PRODUCTS
    • CORPORATE STRATEGY
      Corporate Strategy (Continued)
  • INTRACEL HOLDINGS CORP.
    BUSINESS OVERVIEW
    • PRODUCTS
  • MEDIMMUNE, INC.
    BUSINESS OVERVIEW
    • FINANCIAL INFORMATION
    • LEADING PRODUCTS
• Table 23 MEDIMMUNES PRODUCT PIPELINE
• Table 23 (CONTINUED)
  CORPORATE STRATEGY
  • NABI BIOPHARMACEUTICALS
    BUSINESS OVERVIEW
    • FINANCIAL INFORMATION
    • PRODUCTS
• Table 24 NABI BIOPHARMACEUTICALS PRODUCT PIPELINE
  CORPORATE STRATEGY
  • NORTHWEST BIOTHERAPEUTICS, INC.
    BUSINESS OVERVIEW
    • FINANCIAL INFORMATION
    • PRODUCTS
      Products (Continued)
• Table 25 NORTHWEST BIOTHERAPEUTICS PRODUCT PIPELINE
  CORPORATE STRATEGY
  Corporate Strategy (Continued)
  • PROGENICS PHARMACEUTICALS, INC.
    BUSINESS OVERVIEW
    • FINANCIAL INFORMATION
    • PRODUCTS
• Table 26 PROGENICS PRODUCT PIPELINE
  CORPORATE STRATEGY
  • PSMA DEVELOPMENT CO., LLC
    BUSINESS OVERVIEW
    • FINANCIAL INFORMATION
    • PRODUCTS
    • CORPORATE STRATEGY
  • THERION BIOLOGICS CORP.
    BUSINESS OVERVIEW
    • PRODUCTS
    • CORPORATE STRATEGY
  • TRANSGENE
    BUSINESS OVERVIEW
    • FINANCIAL INFORMATION
    • PRODUCTS
• Table 27 TRANSGENES PRODUCT PIPELINE
  CORPORATE STRATEGY
  • VICAL, INC.
    BUSINESS OVERVIEW
    • PRODUCTS
• Table 28 VICALS PRODUCT PIPELINE
  CORPORATE STRATEGY
  • XENOVA GROUP PLC
    BUSINESS OVERVIEW
    • FINANCIAL INFORMATION
    • PRODUCTS
• Table 29 XENOVAS PRODUCT PIPELINE
  CORPORATE STRATEGY
  • YM BIOSCIENCES INC.
    BUSINESS OVERVIEW
    • FINANCIAL INFORMATION
    • PRODUCTS
• Table 30 YM BIOSCIENCES PRODUCT PIPELINE
  CORPORATE STRATEGY

 LIST OF TABLES

Summary Table:
THE WORLDWIDE MARKET FOR THERAPEUTIC VACCINES BY INDICATION, THROUGH 2010 ($ MILLIONS)

Table 1 THE WORLDWIDE MARKET FOR ADDICTION VACCINES BY TYPE OF ADDICTION, THROUGH 2010 ($ MILLIONS)

Table 2 THE WORLDWIDE MARKET FOR COCAINE ADDICTION VACCINES: THROUGH 2010 ($ MILLIONS)

Table 3 THE WORLDWIDE MARKET FOR NICOTINE ADDICTION VACCINES: THROUGH 2010 ($ MILLIONS)

Table 4 INCIDENCE, MORTALITY, AND SURVIVAL RATES FOR COMMON CANCERS IN THE U.S., 2003

Table 5 CANCER PREVALENCE RATES IN THE U.S., 2003

Table 6 ANNUAL INCIDENCE OF, AND DEATH RATES FOR CANCERS FOR WHICH THERAPEUTIC VACCINES ARE IN DEVELOPMENT IN THE U.S., 2003

Table 7 TYPES OF VACCINES IN DEVELOPMENT FOR CANCER TREATMENT

Table 8 ESTIMATED U.S. MARKET FOR CANCER VACCINES BY INDICATION

Table 9 WORLDWIDE MARKET FOR CANCER VACCINES BY TYPE, THROUGH 2010 ($ MILLIONS)

Table 10 THE MARKET FOR CANCER VACCINES, BY TECHNOLOGY (AUTOLOGOUS VERSUS ALLOGENEIC), WORLDWIDE, THROUGH 2010 ($ MILLIONS)

Table 11 THE WORLDWIDE MARKET FOR CANCER VACCINES, BY INDICATION, THROUGH 2010 ($ MILLIONS)

Table 12 CANCER VACCINES IN PHASE II OR LATER TRIALS

Table 13 TELOMERASE EXPRESSION RATES BY CANCER TYPE

Table 14 SELECTED HIV AND AIDS VACCINES IN PHASE II OR LATER DEVELOPMENT BY DRUG COMPANIES

Table 15 AVI BIOPHARMAS PRODUCT PIPELINE

Table 16 CANCERVAXS PRODUCT PIPELINE

Table 17 THE CELL GENESYS PRODUCT PIPELINE

Table 18 CORIXAS PRODUCT PIPELINE

Table 19 DENDREONS PRODUCT PIPELINE

Table 20 EPIMMUNES PRODUCT PIPELINE

Table 21 GENITOPES PRODUCT PIPELINE

Table 22 GERONS PRODUCT PIPELINE

Table 23 MEDIMMUNES PRODUCT PIPELINE

Table 24 NABI BIOPHARMACEUTICALS PRODUCT PIPELINE

Table 25 NORTHWEST BIOTHERAPEUTICS PRODUCT PIPELINE

Table 26 PROGENICS PRODUCT PIPELINE

Table 27 TRANSGENES PRODUCT PIPELINE

Table 28 VICALS PRODUCT PIPELINE

Table 29 XENOVAS PRODUCT PIPELINE

Table 30 YM BIOSCIENCES PRODUCT PIPELINE  

LIST OF FIGURES

Summary Figure:
THE WORLDWIDE MARKET FOR THERAPEUTIC VACCINES BY INDICATION, 2003-2010

Figure 1 PERCENTAGE OF THE MARKET HELD BY AUTOLOGOUS VERSUS ALLOGENEIC CANCER VACCINES, WORLDWIDE, 2005 AND 2010 (%)

Figure 2 THERAPEUTIC CANCER VACCINE MARKET SHARE BY COMPANY, 2004 AND 2010 (%)