New Trends in Preventive and Therapeutic Vaccines

Published by: CHI Insight Pharma Reports

Published: Oct. 1, 2011 - 138 Pages


Table of Contents

Executive Summary
Chapter 1
INTRODUCTION
1.1. Before the Cure There Was Protection
1.2. Mechanisms of Immunity
1.3. The Universe of Vaccines
Chapter 2
PREVENTIVE VACCINES
2.1. The Infectious Disease Vaccine Industry: Special in Every WayHow Vaccines Are Different
2.2. The Main Types of VaccinesDNA Vaccines: The Third Generation
2.3. Regulatory Handling of VaccinesVaccine Testing and Approval in the United States
Vaccine Regulation in Europe
No Generics with Vaccines
2.4. Diseases and the State of Available VaccinesBacterial Infections
Viral Infections
Hepatitis
Influenza
Poliomyelitis
Rabies
Spreading Tropical Viruses
Japanese Encephalitis Virus
Human Immunodeficiency Virus and AIDS
Malaria
2.5. The Corporate PlayersLarge Pharmaceutical Players in the Vaccine Business
Baxter Vaccines
GlaxoSmithKline Vaccines
Johnson & Johnson Center for Vaccines
Novartis Vaccines and Diagnostics GmbH & Co. KG
Pfizer Vaccines
Sanofi Pasteur MSD
Small Vaccine Specialist Companies
AlphaVax
Bavarian Nordic
Bionor Pharma
ChronTech Pharma
DynPort Vaccine Company
Emergent BioSolutions
EpiVax
Genocea Biosciences
GenVec
Inovio Pharmaceuticals
Intercell
Medicago
MedImmune Vaccines
Mymetics
Novavax
Sinovac Biotech
Synthetic Genomics Vaccines
VaxInnate
Vical
2.6. Global InitiativesThe WHO Initiative for Vaccine Research (IVR)
The Global Alliance for Vaccines and Immunization (GAVI)
The Bill & Melinda Gates Foundation
The United Nations Children's Fund (UNICEF)
Pediatric Vaccines: A Multivalent Universe
2.7. The Market for Infectious Disease VaccinesIntellectual Property and the Vaccine Market
Mixed Prospects for an HIV Vaccine
2.8. Opposition to Vaccination: A Persistent PhenomenonThe Coalition for Vaccine Safety (CVS)
2.9. Vaccine Design, Formulation, and DeliveryGenetic Engineering and Rational Design of Antigens
Increasing Efficacy of DNA Vaccines
The Adjuvant Revolution: Nanoparticulate Vaccines and ISCOM Technologies
Intradermal and Needle-Free Transdermal Delivery
Oral Vaccines: From Niche Toward Mainstream
2.10. Infectious Disease Vaccines in a Globalized WorldInternational Travel, Migration, and Climate Change Drive New Vaccine Demands
SARS: A Model Event for an Emerging Pandemic Virus
Influenza: The Big Pandemic Continues to Loom
Planning and Logistics of Modern Mass Vaccination Campaigns
Bioterrorism and Biowarfare: Countermeasures for "The Next Very Bad Thing"
2.11. The Challenge of the ParasitesWhy Vaccination Against Parasites Is Difficult
The Quest for a Malaria Vaccine
Schistosomiasis
Neglected Tropical Diseases and the Major Pharma Markets
Chapter 3
THERAPEUTIC VACCINES
3.1. A Continuum with Immunotherapies
3.2. Postexposure Therapy for Viral DiseasesHepatitis C: Therapeutic Hopes in the Absence of Protection
AIDS: Still the Hotbed for Therapeutic Vaccine Development
3.3. Potential Vaccination Targets Outside the Mainstream: Autoimmune Diseases and BeyondAsthma and Allergy
Autoimmune Conditions: Type 1 Diabetes, Psoriasis, Arthritis, Multiple Sclerosis, and Transplant Rejection
Type 1 Diabetes
Multiple Sclerosis
Rheumatoid and Psoriatic Arthritis
Atherosclerosis
Periodontitis
Transplant Rejection
Alzheimer's Disease
3.4. The Most Unlikely Vaccine TargetsDrug Abuse and Smoking
Limited Hopes for Obesity
Cachexia
Macular Degeneration
Chapter 4
CANCER VACCINES
4.1. Objectives and Criteria for a Cancer VaccineProphylaxis and Therapy Rolled into One
Therapeutic Cancer Vaccines: Breaking Immune Tolerance
Cancer Vaccines and Regulatory Authorities
4.2. The Status Quo: Cancer Vaccines Approved in the United States and
ElsewhereGardasil and Cervarix to Prevent Cervical Cancer
Provenge for Prostate Adenocarcinoma
OncoVAX to Prevent Colon Cancer Recurrence
Melacine for Melanoma
Oncophage
CimaVax EGF
4.3. Cancer Vaccines in Clinical Developmentgp100:209-217(210M) (National Cancer Institute)
Lucanix (Belagenpumatucel-L) (NovaRx Corp.)
GVAX (BioSante Pharmaceuticals [formerly Cell GeneSys])
Stimuvax (Emepepimut-S) (Merck KGaA/Oncothyreon)
TroVax (MVA-5T4) (Oxford BioMedica)
GSK1572932A (GlaxoSmithKline)
Prostvac-VF/TRICOM (BN Immunotherapeutics)
OPT-822 (Optimer Biotechnology)
IMA901 (Immatics Biotechnologies GmbH)
GV1001 (KAEL-GemVax)
Candidates to Enter Phase III
TG-4010 (Transgene SA)
Rindopepimut (CDX-110) (Avant Immunotherapeutics)
Selected Phase I/II Candidate Vaccines
ONY-P (VaxOnco)
DPX-0907 and DPX-Survivac (Immunovaccine)
ADXS11-001 (Advaxis)
IDM-2101 (BioTech Synergy)
VGX-3100 (Inovio Pharmaceuticals)
SCIB1 (Scancell Holdings)
HyperAcute Vaccines (NewLinkGenetics Corp./Ochsner Health System)
PEP-223/CoVaccine HT (Pepscan Systems BV)
ImMucin (Vaxil BioTherapeutics)
GI-4000 and GI-6207 (GlobeImmune)
PEV-6A (Pevion Biotech and Bio Life Science)
4.4. Market Potential for Cancer Vaccines
Chapter 5
VACCINE PERSPECTIVES TO 2020
5.1. Bioinformatics, Simulations, and In Silico Vaccinology
5.2. Toward the "Universalization" of Vaccines?
5.3. The Future of Vaccine Patenting
5.4. Commercial Scenarios for Vaccines
5.5. Summary
References
Company Index
FIGURES
Figure 1.1 Survey Respondents’ Opinions on Role of Vaccines vs. Small Molecules To 2020 1
Figure 1.2 Overview of B- and T-Cell Activation 4
Figure 2.1 Evolution of Influenza Strains 16
Figure 2.2 West Nile Virus (WNV) Activity Reported to ArboNET, by United States, 2010 22
Figure 2.3 Design of Study RV144, the First to Show Efficacy for a Preventive HIV Vaccine 25
Figure 2.4 Longitudinal Development of HIV Incidence, HIV Prevalence, and AIDS-Related Deaths Worldwide, 1990–2009 46
Figure 2.5 Total Annual Global Revenue Forecasts for a First-Generation Preventive HIV Vaccine 48
Figures 2.6–2.9 Survey Respondents’ Opinions on Prophylactic HIV Vaccines 50
Figure 2.10 Survey Respondents’ Opinions of Root Causes for Anti-Vaccination Movement 52
Figures 3.1–3.4 Survey Respondents’ Opinions on HIV and HCV Vaccines 70
Figure 3.5 Survey Respondents’ Opinions on Therapeutic Vaccines in General 83
Figures 4.1–4.7 Survey Respondents’ Opinions on Cancer Vaccines 102
Figure 5.1 Survey Respondents’ Opinions Concerning Development Goals for Infectious Disease Vaccines 105
Figures 5.2–5.3 Survey Respondents’ Opinions on Vaccines Market Development To 2020 108

Abstract

This report provides an analytical snapshot of the current state of the vaccine industry, its development efforts, and an outlook to 2020, examining:
  • Vaccines for prevention of infectious diseases including hepatitis, influenza, polio, rabies, tropical viruses, and HIV
  • Therapeutic vaccines that target HIV, HCV, asthma and allergy, type 1 diabetes, multiple sclerosis, psoriasis, arthritis, atherosclerosis, transplant rejection, Alzheimer’s disease, periodontitis, substance abuse, obesity, cachexia, and age-related macular degeneration
  • Therapeutic cancer vaccines, including all cancer vaccines currently known to be in Phase III clinical trials and an overview of products that are in Phase I or II
  • Perspectives for vaccine development, the direction the markets are likely to take to 2020, and estimates for market growth
  • Results of a four-part survey offering unique insights into industry sentiment concerning vaccine development to 2020
  • Advances in vaccine design, formulation, and delivery
  • Company profiles of large pharmaceutical players in the vaccine business and small vaccine specialist companies
New Trends in Preventive and Therapeutic Vaccines: R&D Activities and Commercial Prospects begins by dealing with the major task of vaccines: prevention of infectious diseases. A thorough overview of vaccine-preventable diseases is given, with a special focus on human immunodeficiency virus (HIV), hepatitis C, and influenza. We use the case of a potential HIV vaccine for an analysis of how the first vaccine for a previously “unvaccinable” major infectious disease could fare, on the market and in terms of epidemiological impact, assuming several scenarios. The major corporate players on the market, and vaccine specialist companies including those developing or selling vaccines for “weaponized” biological agents such as anthrax, are reviewed as are the international organizations and the charities, which play the dominant role in making standard vaccines accessible to the developing nations. Attention is given to emerging tropical viral diseases (such as Dengue and West Nile virus), which are increasingly spreading to the temperate zones of the globe. A special section is devoted to the challenge of tropical parasitic diseases. Opposition to vaccination is also discussed.

We then turn to therapeutic vaccines that target chronic infectious diseases, but also non-infectious conditions with massive immune system involvement. A special section addresses efforts to develop therapeutic vaccines for conditions that most people would not consider targets for this type of intervention. Therapeutic cancer vaccines are covered in a separate chapter. This part of the report reviews the paradigms of active immune intervention in cancer and the problems it faces, as well as discusses cancer vaccines in clinical development. Standardized cancer vaccines, which work by harnessing the patient’s immune system, should offer a completely new therapeutic angle. Most importantly, they would be best suited to prevent tumor recurrence once a complete remission has been achieved by initial therapy—which would open an entirely new perspective for cancer survivors, and a completely new market as well.

Insight Pharma Reports conducted a four-part online survey in late September/early October 2011, which covered preventive vaccines for infectious diseases in general, influenza vaccines, HIV and HCV vaccines, and cancer vaccines. Analyses of the responses can be found throughout this report.

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