BioDefense Solutions

biodefense solutions Mr. Frank M. Rapoport
Attorney
Partner
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>>

Bio-terrorism
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.

Acambis (www.acambis.com) 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 organizations.

Baxter International (www.baxter.com), is the principal U.S. operating subsidiary of Baxter International Inc. (NYSE: BAX - News). 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 technology.

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).

Cepheid (www.cepheid.com), 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.

biodefense solutions Gen-Probe (www.gen-probe.com) 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.

All of these companies are included in our Investment Guide To 350+ Security Stocks ©.