Mr. Frank M. Rapoport
McKenna Long & Aldridge
"BioShield I, which was passed in 2004, is the most significant
piece of biodefense legislation. It provided $5.6 billion in funding for
biodefense. Part of the legislation authorizes HHS to create a national
stockpile of vaccines against bioterror agents.
The Department of
Defense has awarded contracts to create national stockpiles of vaccines
to vaccinate troops. In fact, the DOD has even awarded contracts for
vaccines which are still in Phase III trials. These military stockpiles
are entirely separate from the DHS' and HHS' funds for civilian
stockpiles. In fact, the DOD is purchasing stockpiles for troops prior
to licensure, when vaccines are still in Phase 3 development. By
providing funds for Phase 3 development, the government is stepping in
early to absorb part of the risk of development. This reduces the risk
profile of development of biodefense products.
The National Institutes of Health is a key source of grant funding for
biodefense research, especially in Phases 1 and 2. In FY 07, the NIH's
biodefense research portfolio is expected to be $1.9 billion, a 6.1%
increase since FY 06." More>>
We are vulnerble to numerous biological threats, including anthrax, Ebola,
smallpox, nerve gas, and bubonic plague attacks, among others. Threats
from new diseases and viruses such as Monkey pox, Mad Cow, SARS and West
Nile are emerging rapidly. The companies selected for our BioDefense Watchlist
are beneficiaries of increased spending to guard against these threats
and disease management. The companies we are tracking include: Applera,
Acambis, Avant Immunotherapeutics, Baxter, Bruker, Cubist Pharmaceuticals,
Cepheid, Gen-Probe, Hollis-Eden Pharmaceuticals, Isis Pharmaceuticals,
RAE Systems, and Steris.
Applera Corporation consists of two operating groups: Applied Biosystems
and Celera Genomics. The Applied Biosystems Group (www.appliedbiosystems.com)
serves the life science industry and research community by developing
and marketing instrument-based systems, consumables, software, and services.
Customers use these tools to analyze nucleic acids (DNA and RNA), small
molecules, and proteins to make scientific discoveries, develop new pharmaceuticals,
and conduct standardized testing. Applied Biosystems is headquartered
in Foster City, CA, and reported sales of $1.7 billion during fiscal 2003.
The Celera Genomics Group located in Rockville, MD, and South San
Francisco, CA, is engaged principally in integrating advanced technologies
to discover and develop new therapeutics.
is a leading developer of vaccines
created to prevent and treat infectious diseases. Recognized internationally
as the leading producer of smallpox vaccines, Acambis is developing a
second-generation smallpox vaccine, which is currently undergoing clinical
trials. Under a unique arrangement given the threat of smallpox being
used as a bioterrorist weapon, the Company manufactures emergency-use
stockpiles of this investigational vaccine for the US Government and other
governments around the world. Acambis also established a travel vaccines
franchise through its US-based subsidiary Berna Products Corporation,
which markets Vivotif®, the world's only licensed oral typhoid vaccine
in North America. The Company has a number of other potential travel vaccines
in development and is also developing a vaccine against the West Nile
virus, which has spread to 46 US States in the last five years.
AVANT Immunotherapeutics (www.avantimmune.com)
discovers, develops and sells innovative vaccines and therapeutics that
harness the human immune system to prevent and treat disease. The company
has developed a broad, well-staged pipeline of vaccines and therapeutics
for large, high-value, under-served markets. Six of AVANT's products are
in clinical development. These include an oral human rotavirus vaccine,
a treatment to reduce complement-mediated tissue damage associated with
cardiac by-pass surgery, and a novel vaccine for cholesterol management.
AVANT has also assembled a technology platform that enables the creation
of rapidly-protecting, single-dose, oral vaccines that remain stable without
refrigeration. The company is developing applications of this vaccine
technology in four areas: biodefense, travelers' vaccines, global health
needs, and human food safety. AVANT's goal is to demonstrate proof-of-concept
for its products before leveraging further development through both traditional
pharmaceutical partnerships and collaborations with governmental and other
Baxter International (www.baxter.com),
is the principal U.S. operating subsidiary of Baxter International Inc.
Baxter International Inc., through its subsidiaries, assists healthcare
professionals and their patients with the treatment of complex medical
conditions, including hemophilia, immune disorders, cancer, infectious
diseases, kidney disease, trauma and other conditions. The company applies
its expertise in medical devices, pharmaceuticals and biotechnology to
make a meaningful difference in patients' lives.
Bruker BioSciences (www.bruker-biosciences.com),
in Billerica, Massachusetts is the parent company of Bruker AXS Inc.,
Bruker Daltonics Inc. and Bruker Optics, Inc. Bruker AXS is a leading
developer and provider of life science, materials research and industrial
X-ray analysis tools. Bruker Daltonics is a leading developer and provider
of innovative life science tools based on mass spectrometry, and also
offers a broad line of nuclear, biological and chemical (NBC) detection
products for homeland security. Bruker Optics is a leading developer,
manufacturer and provider of research, analytical and process analysis
instruments and solutions based on infrared and Raman molecular spectroscopy
Cubist Pharmaceuticals (www.cubist.com)
is a biopharmaceutical company focused on research, development and commercialization
of drugs that respond to significant unmet medical needs. Since its founding
in 1992, Cubist has been exclusively focused on exploiting business and
product opportunities in the anti-infective marketplace. In the U.S.,
Cubist markets Cubicin(TM) (daptomycin for injection), the first antibiotic
in a new class of antiinfectives called lipopeptides, for the indication
of complicated skin and skin structure infections caused by Gram-positive
bacteria. CUBICIN is currently the only once-daily bactericidal antibiotic
approved in the U.S. with activity against both methicillin-susceptible
and methicillin-resistant Staphylococcus aureus (MSSA and MRSA).
based in Sunnyvale, California, is a leading developer, manufacturer and
marketer of fully integrated systems that enable genetic assessment when
and where it is needed. Founded in 1996, the company is commercializing
its technology and products world wide for research, medical, and industrial
applications requiring assessment of the human genome, infectious disease
and biothreat agents.
is a global leader in the development, manufacture and marketing of rapid,
accurate and cost-effective nucleic acid testing (NAT) products used for
the clinical diagnosis of human diseases and for screening donated human
blood. Using its patented NAT technologies, Gen-Probe has received FDA
approvals or clearances for a broad portfolio of products that detect
a variety of infectious microorganisms, including those causing sexually
transmitted diseases, tuberculosis, strep throat, pneumonia and fungal
infections. Additionally, the Company developed and manufactures the only
FDA-approved blood screening assay for the simultaneous detection of HIV-1
and HCV, which is marketed by Chiron. Gen-Probe has more than 20 years
of expertise in nucleic acid detection and its products are used daily
in clinical laboratories and blood collection centers throughout the world.
Gen-Probe is headquartered in San Diego and has approximately 800 employees.
Hollis-Eden Pharmaceuticals (www.holliseden.com),
is a development-stage pharmaceutical company based in San Diego, California,
working to become the world leader in the development of a new class of
investigational drugs known as Immune Regulating Hormones (IRHs). The
goal of IRH therapy is to direct, through controlling gene expression,
the production of key cytokines and enzymes that re-regulate immune and
metabolic functions toward homeostasis, a profile that could be useful
in a wide variety of diseases. The Company has a number of investigational
IRHs under development, including NEUMUNE(TM), which the Company is co-developing
with the U.S. military for use in protection from radiation injury; PHOSPHONOL(TM),
a candidate for providing protection against DNA mutations from radiation
exposure and chemotherapy treatment; and IMMUNITIN(TM), which has shown
activity in a variety of infectious diseases, including HIV/AIDS, tuberculosis
and malaria. Hollis-Eden is also developing IRHs for protection from chemotherapy
and other conditions of immune dysregulation.
Isis Pharmaceuticals (www.isispharm.com),
is exploiting its expertise in RNA to discover and develop novel human
therapeutic drugs for its pipeline and its partners. The company has successfully
commercialized the world's first antisense drug and has 11 antisense products
in development to treat metabolic, cardiovascular, inflammatory and viral
diseases and cancer. Through its Ibis Therapeutics® program, Isis is developing
a biosensor to identify infectious organisms, and is discovering small
molecule drugs that bind to RNA. As an innovator in RNA-based drug discovery
and development, Isis is the owner or exclusive licensee of more than
1,300 issued patents worldwide.
RAE Systems (www.raesystems.com)
is a leading global developer and manufacturer of rapidly deployable,
multi-sensor chemical detection monitors and networks for homeland security
and industrial applications. In addition, RAE Systems offers a full line
of portable single-sensor chemical and radiation detection products. RAE
Systems' products enable the military and first responders such as firefighters,
law enforcement and other emergency management personnel to detect and
provide early warning of weapons of mass destruction and other hazardous
materials. Industrial applications include the detection of toxic industrial
chemicals, volatile organic compounds and petrochemicals. RAE Systems'
products are used by many U.S. government agencies, including the Department
of Homeland Security, the Department of Justice, and the Department of
State, as well as all branches of the U.S. military, and by numerous city
and state agencies. Our end users also include many of the world's leading
corporations in the airline, automotive, computer and oil industries.
Our products are used in civilian and government atmospheric monitoring
programs in over 50 countries.
Steris Corporation (www.steris.com)
is a multi-faceted global organization that has two operating segments:
healthcare and scientific and industrial. The healthcare business consists
of products and services utilized by healthcare professionals to significantly
reduce or eliminate microbial contamination within the healthcare environment.
The portfolio includes infection prevention processing systems and specialty
chemical products used for cleaning, disinfecting, sterilizing, drying
and aerating medical and surgical instruments, devices and hard surfaces.
The Steris scientific and industrial offerings include contamination prevention
and control systems, products and services for pharmaceutical, biotechnology,
biodefense solutins, medical device, critical research, laboratory research
and industrial customers worldwide.