Biodefense Industry
Market to Benefit from Federal Funding such as the BIO EDEP Fund to Support
Security Plans
GBI Research Report Guidance
GBI Research Report Guidance
· The second chapter provides an introduction to the biodefense industry.
· Section three is entitled “Biodefense Industry – Regulatory Environment”. This section comprises the
introduction to the regulatory environment. It also details the regulatory agencies’ roles and describes
key findings on Project Bioshield.
· Section four is entitled “Biodefense Industry – Pathogens and Pipeline”. This section includes analysis
of the leading classes of pathogens in bioterrorism, such as anthrax, smallpox, tularemia, viral
hemorrhagic fever and plague.
· Section five describes funding opportunities and agencies in the biodefense field in the US and Europe.
· Section six provides a detailed case study of anthrax decontamination by Sabre LLC.
· Section seven covers the competitive activity in the biodefense industry. The section provides company
profiles of 13 major companies active in the biodefense industry. This section also describes the
biodefense contracts gained by industry participants during 2007–2012.
© GBI Research. This is a licensed product and is not to be photocopied GBIHC219MR / Published SEP 2012
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Biodefense Industry – Executive Summary
Biodefense Industry – Executive Summary
Anthrax, Smallpox and Viral Hemorrhagic Fever Dominate the R&D Pipeline, Contributing 95% of the
Molecules
Anthrax and smallpox are Biodefense Industry, Pipeline by Pathogens (%), 2012
among the most researched
diseases in the biodefense Tularemia
industry. 1%
Plague
4%
Anthrax
Viral Hemorrhagic
24%
Fever
39%
Small Pox
32%
Source: GBI Research; GBI Research Proprietary Database [Accessed April 10, 2012]
According to GBI Research, the research and development in the biodefense industry is focused on three
main pathogens, namely viral hemorrhagic fever, anthrax and smallpox. Viral hemorrhagic fever (39%)
Anthrax (24%) and smallpox (32%) contributed a total of 95% of the molecules in the biodefense industry
pipeline. Anthrax and smallpox are among the most researched diseases in the biodefense industry. This is
due to their high potential for destruction. They can be easily transmitted through air and could cause
widespread destruction of human lives during a bioterrorist attack.
Anthrax has 22 molecules in various stages of development. The anthrax pathogen has received extensive
funding from the Biomedical Advanced Research and Development Authority (BARDA), the National
Institute of Allergy and Infectious Diseases (NIAID), and the National Institute of Health (NIH). Human
Genome Sciences (HGS), which received a contract worth $151m from BARDA, has developed ABthrax
(raxibacumab), a human monoclonal antibody for an anthrax protein antigen. The molecule is currently
seeking a biological license application.
Smallpox has 30 molecules in various stages of development. Despite being eradicated in 1980, the
pathogen still continues to hold importance in today’s changing security scenarios. Various government
security and research agencies have considered the risk that smallpox could be widely used by terrorist
organizations in a bioterrorist attack. IMVAMUNE, a third generation smallpox vaccine by Bavarian Nordic,
is the most promising molecule for treatment, if necessary.
© GBI Research. This is a licensed product and is not to be photocopied GBIHC219MR / Published SEP 2012
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Biodefense Industry – Executive Summary
SIGA Technologies and Emergent Biosolutions were Awarded a Total of 15 Biodefense Contracts between
2007 and 2012
Biodefense Industry, Number of Biodefense Contracts by Company, 2007–2012
9
8
8
7
7
Number Of Contracts 6
5
4
3 3 3
3
2 2
2
1 1 1 1 1 1
1
0
Pharmathene
Pharmacueticals
Achaogen
NanoTherapeutics
Therapeutics
Ichor Medical
Dynport Vaccine
Technologies
Technologies
Bavarian Nordic
SIGA Technologies
Biosolutions
Cleveland Biolabs
Company LLC
Emergent
Dynavax
Systems
Elusys
XOMA
Alnylam
Source: GBI Research’s Proprietary Database [accessed on: April 5, 2012]
Biodefense is a niche industry, and only a limited number of companies have a presence in the field.
Revenue generation is through grants or contracts awarded to the pharmaceutical or biotechnology
companies by various security and research and development agencies, such as the US Food and Drug
Administration (FDA), the Centers for Disease Control and Prevention (CDC), the Department of Health and
Human Services (HHS), NIAID, NIH, and BARDA.
According to GBI Research’s analysis, Emergent Biosolutions and SIGA Technologies were awarded a total of
15 contracts between 2007 and 2012. Emergent Biosolutions was awarded a contract to supply 44.8 million
doses of BioThrax vaccine over a period of five years. The company was also awarded an HHS contract
valued at $186.6m to develop a Recombinant Protective Antigen (rPA) anthrax vaccine in 2010.
SIGA Technologies was awarded eight contracts between 2007 and 2012. The company received a $7.7m
grant for the development of antiviral drugs for treating and preventing Lassa fever and other hemorrhagic
fevers of arenavirus in 2011. It was also awarded a contract to sell 1.7 million courses of St-246 to the US
National Stockpile under a modified BARDA contract in 2011.
© GBI Research. This is a licensed product and is not to be photocopied GBIHC219MR / Published SEP 2012
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Biodefense Industry – Executive Summary
A $135m BIO-EDEP Program to Address a Range of Scientific, Public Health and National Security Issues in
Europe
In May 2009, the European Defense Agency (EDA) endorsed an ad hoc Category B program on the
preparation phase of a “Biological Equipment Development and Enhancement Programme” (BIOEDEP). The
BIOEDEP program comprises eight projects, which cover individual protection, non-specialist unit all-arms
Chemical, Biological, Radiological and Nuclear (CBRN) defense protection, and specialist capabilities.
The specific aim of the preparation phase is to develop Common Staff Requirements (CSR) for individual
soldier protection, non-specialist all-arms CBRN defense unit protection, and CBRN defense specialists’
equipment capability, leading to options for the realization of BIOEDEP. The preparation phase will result in
the elaboration of eight CSR documents describing the specific requirements for each of the eight sub-
systems, which will eventually build up the Biological Integrated Reconnaissance Defence (BIRD) system by
the end of the year.
© GBI Research. This is a licensed product and is not to be photocopied GBIHC219MR / Published SEP 2012
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Table of Contents
1 Table of Contents
1 Table of Contents ........................................................................................................................................ 6
1.1 List of Tables .................................................................................................................................... 8
2 Biodefense Industry – Introduction ............................................................................................................ 9
3 Biodefense Industry – Regulatory Environment ....................................................................................... 10
3.1 Regulatory Agencies ...................................................................................................................... 10
3.1.1 Food and Drug Administration .............................................................................................. 10
3.1.2 Project Bioshield .................................................................................................................... 10
4 Biodefense Industry – Pathogens and Pipeline ......................................................................................... 12
4.1 Anthrax .......................................................................................................................................... 12
4.1.1 Introduction ........................................................................................................................... 12
4.1.2 Treatment Options ................................................................................................................ 12
4.1.3 Anthrax Product Pipeline Analysis ......................................................................................... 13
4.2 Smallpox ........................................................................................................................................ 14
4.2.1 Introduction ........................................................................................................................... 14
4.2.2 Treatment Options ................................................................................................................ 14
4.2.3 Smallpox Product Pipeline Analysis ....................................................................................... 15
4.3 Viral Hemorrhagic Fevers .............................................................................................................. 16
4.3.1 Introduction ........................................................................................................................... 16
4.3.2 Treatment Options ................................................................................................................ 17
4.3.3 Viral Hemorrhagic Fevers Product Pipeline Analysis ............................................................. 17
4.4 Plague ............................................................................................................................................ 19
4.4.1 Introduction ........................................................................................................................... 19
4.4.2 Treatment Options ................................................................................................................ 19
4.4.3 Plague Product Pipeline Analysis ........................................................................................... 19
4.5 Tularemia ...................................................................................................................................... 20
4.5.1 Introduction ........................................................................................................................... 20
4.5.2 Treatment Options ................................................................................................................ 20
4.5.3 Tularemia Product Pipeline Analysis ..................................................................................... 20
5 Biodefense Industry – Funding.................................................................................................................. 21
5.1 Introduction................................................................................................................................... 21
5.2 Biodefense Funding – The US ........................................................................................................ 21
5.2.1 Department of Health and Human Services .......................................................................... 21
5.2.2 Biomedical Research and Development Authority ................................................................ 21
5.2.3 NIH Challenge Grants in Health and Science Research.......................................................... 22
5.2.4 NIH Cooperative Research and Development Agreement (CRADA) ...................................... 22
5.2.5 NIH Small Business Biodefense Program Awards .................................................................. 22
5.2.6 Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases ................ 23
5.2.7 Defense Threat Reduction Agency (DTRA)............................................................................. 26
5.2.8 US Army Medical Research Institute of Infectious Diseases (USAMRIID) .............................. 27
5.2.9 Defense Advanced Research Projects Agency (DARPA) ......................................................... 27
5.3 Biodefense Funding – Europe ........................................................................................................ 27
5.3.1 EU Biodefense Programs ....................................................................................................... 27
5.3.2 European Defense Agency (EDA) ........................................................................................... 27
5.3.3 Bio-Edep ................................................................................................................................ 27
5.3.4 New and Emerging Science and Technology (NEST).............................................................. 28
5.3.5 Health Protection Agency (HPA)............................................................................................ 28
6 Biodefense Industry – Case Study ............................................................................................................. 29
6.1 Case Study – Anthrax Contamination ............................................................................................ 29
6.1.1 Company – Sabre Technical Services LLC............................................................................... 29
6.1.2 Solution – Facility Decontamination with Chlorine Dioxide (ClO2) Gas ................................. 29
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Table of Contents
7 Biodefense Industry – Competitive Landscape ......................................................................................... 31
7.1 Achaogen ....................................................................................................................................... 31
7.1.1 Biodefense Contracts............................................................................................................. 31
7.2 Alnylam Pharmaceuticals .............................................................................................................. 31
7.2.1 Biodefense Contracts............................................................................................................. 31
7.3 Bavarian Nordic ............................................................................................................................. 32
7.3.1 Biodefense Contracts............................................................................................................. 32
7.4 Cleveland BioLabs .......................................................................................................................... 33
7.4.1 Biodefense Contracts............................................................................................................. 33
7.5 Dynavax Technologies Inc. ............................................................................................................ 34
7.5.1 Biodefense Contracts............................................................................................................. 34
7.6 Dynport Vaccine Company LLC (DVC) ............................................................................................ 34
7.6.1 Biodefense Contracts............................................................................................................. 34
7.7 Elusys Therapeutics ....................................................................................................................... 35
7.7.1 Biodefense Contracts............................................................................................................. 35
7.8 Emergent BioSolutions .................................................................................................................. 36
7.8.1 Biodefense Contracts............................................................................................................. 37
7.9 Ichor Medical Systems ................................................................................................................... 39
7.9.1 Biodefense Contracts............................................................................................................. 39
7.10 Nanotherapeutics .......................................................................................................................... 39
7.10.1 Biodefense Contracts............................................................................................................. 39
7.11 PharmAthene ................................................................................................................................ 40
7.11.1 Biodefense Contracts............................................................................................................. 40
7.12 SIGA Technologies ......................................................................................................................... 41
7.12.1 Biodefense Contracts............................................................................................................. 41
7.13 XOMA ............................................................................................................................................ 43
7.13.1 Biodefense Contracts............................................................................................................. 43
8 Biodefense Industry – Appendix ............................................................................................................... 44
8.1 Market Definitions......................................................................................................................... 44
8.2 Abbreviations ................................................................................................................................ 44
8.3 Bibliography .................................................................................................................................. 46
8.4 Research Methodology ................................................................................................................. 47
8.4.1 Coverage ............................................................................................................................... 47
8.4.2 Secondary Research .............................................................................................................. 48
8.4.3 Primary Research .................................................................................................................. 48
8.4.4 Section-Wise Methodology ................................................................................................... 48
8.4.5 Expert Panel Validation ......................................................................................................... 49
8.5 Contact Us ..................................................................................................................................... 49
8.6 Disclaimer ...................................................................................................................................... 49
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Table of Contents
1.1 List of Tables
Table 1: Biodefense Industry, Anthrax Pipeline Analysis, Discovery Molecules, 2012 ............................... 13
Table 2: Biodefense Industry, Anthrax Pipeline Analysis, Pre-Clinical Molecules, 2012 ............................ 13
Table 3: Biodefense Industry, Anthrax Pipeline Analysis, Phase I Molecules, 2012 ................................... 13
Table 4: Biodefense Industry, Anthrax Pipeline Analysis, Phase II Molecules, 2012 .................................. 13
Table 5: Biodefense Industry, Anthrax Pipeline Analysis, Phase III Molecules, 2012 ................................. 14
Table 6: Biodefense Industry, Anthrax Pipeline Analysis, NDA Filed Molecules, 2012 .............................. 14
Table 7: Biodefense Industry, Smallpox Pipeline Analysis, Discovery Molecules, 2012 ............................. 15
Table 8: Biodefense Industry, Smallpox Pipeline Analysis, Pre-Clinical Molecules, 2012 .......................... 15
Table 9: Biodefense Industry, Smallpox Pipeline Analysis, Phase I Molecules, 2012 ................................. 15
Table 10: Biodefense Industry, Smallpox Pipeline Analysis, Phase II Molecules, 2012 ................................ 16
Table 11: Biodefense Industry, Smallpox Pipeline Analysis, Phase III Molecules, 2012 ............................... 16
Table 12: Biodefense Industry, Smallpox Pipeline Analysis, NDA Filed Molecules, 2012 ............................. 16
Table 13: Biodefense Industry, Viral Hemorrhagic Fever Pipeline Analysis, Phase I Molecules, 2012 ......... 17
Table 14: Biodefense Industry, Viral Hemorrhagic Fever Pipeline Analysis, Phase II Molecules, 2012 ........ 18
Table 15: Biodefense Industry, Viral Hemorrhagic Fever Pipeline Analysis, Phase III Molecules, 2012 ....... 18
Table 16: Biodefense Industry, Plague Pipeline Analysis, Phase I Molecules, 2012 ..................................... 19
Table 17: Biodefense Industry, Plague Pipeline Analysis, Phase II Molecules, 2012 .................................... 19
Table 18: Biodefense Industry, Tularemia Pipeline Analysis, Phase II Molecules, 2012............................... 20
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Biodefense Industry – Introduction
2 Biodefense Industry – Introduction
Bioterrorism can be defined as the intentional or deliberate release of harmful agents such as viruses,
bacteria or toxins, which can cause illness and death in people, animals, or plants. The agents are found
naturally and can be mutated to increase their ability to cause disease. The alterations can also lead to them
becoming resistant to medicines and enhance their ability to be spread in the environment. The harmful
agents can be spread through air, water or food.
Foot and Mouth Disease (FMD) virus is one of the major pathogens capable of causing damage both socially
and economically. The FMD outbreak was witnessed in 2002 and 2007. The FMD virus cannot spread in
human beings.
The US is in possession of weapons of mass destruction; the country is known to have nuclear weapons,
chemical weapons and biological weapons. The US is the only country which has used a nuclear weapon in
combat, as occurred in World War II. The US biological weapons program was initiated in 1943 on the
orders of President Franklin Roosevelt. The research continued after World War II, and the US has built a
large stockpile of biological agents and weapons. President Richard Nixon ended all non-defensive aspects
of the US bio-weapons program in 1969. In 1975, the international treaties outlawing biological warfare
such as the 1925 Geneva Protocol and the 1972 Biological Weapons Convention (BWC) were ratified by the
US.
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Biodefense Industry – Regulatory Environment
3 Biodefense Industry – Regulatory Environment
3.1 Regulatory Agencies
3.1.1 Food and Drug Administration
The FDA is involved in a critical and multidimensional role, which involves the development of regulatory
The OCET is responsible for human and veterinary medical products and monitoring the food and blood supplies of the US. Its
the development and regulatory responsibilities are critical to any deliberate threat, which can be biological, radiological, or
availability of safe and nuclear.
effective public health
The Office of Counterterrorism and Emerging Threats (OCET) is responsible for the development and
emergency medical
availability of safe and effective public health emergency medical countermeasures. It also facilitates policy
countermeasures
formulation to safeguard medical products from adulteration and to prevent disruption of supplies due to
terrorist activities.
The OCET also provides strategic leadership and coordination for the FDA’s counterterrorism and emerging
threat portfolios. It also works to identify and resolve complex scientific and regulatory challenges facing
medical