Federal grants support new anthrax countermeasures

Oct 3, 2007 (CIDRAP News) – Two pharmaceutical companies recently announced they received federal biodefense grants totaling $21.5 million to support the development of products that could be used to counter an anthrax attack.

Elusys Therapeutics, based in Pine Brook, N.J, said in a Sep 25 statement that it had been awarded a $12 million contract to continue developing AnthrimTM, the company's late-stage anthrax treatment.

Anthrim is a high-affinity monoclonal antibody that targets the protective antigen component of anthrax infection, blocking the organism's ability to form deadly toxins, Elusys said in its statement. The company is developing the drug for prophylaxis and postexposure treatment of inhalational anthrax.

The US Food and Drug Administration (FDA) has granted the drug fast-track approval status and has designated it as an orphan drug, according to the Elusys statement.

Elizabeth Posillico, PhD, president and chief executive officer of Elusys, said in the statement that inhalation of anthrax spores quickly leads to death in nonvaccinated patients unless they receive immediate antibiotic treatment. She added that Anthrim represents a "just-in-time" anthrax treatment that, "in relevant models has demonstrated complete protection against anthrax spore challenge with a single prophylactic dose, and has shown significant protection when administered up to 2 days after a lethal spore challenge, with or without an antibiotic."

In a related development, Emergent BioSolutions, based in Rockville, Md., announced on Sep 27 that it had received a $9.5 million contract from the federal government to develop its anthrax therapeutic, anthrax immune globulin (AIG).

The company said the grant would be used to support nonclinical efficacy studies and to launch a phase 1/2 clinical study to evaluate pharmokinetics and safety. The new funds supplements a $3.9 million grant the company received in August 2006 to develop AIG.

As an intravenous therapy for patients who present with anthrax disease symptoms, AIG, if successfully developed, could be prescribed by itself or along with an antibiotic, the company said in its statement.

The product is developed from plasma collected from healthy donors who have been vaccinated with BioThrax, Emergent BioSolutions' anthrax vaccine, which is the only such product approved by the FDA for preventing anthrax infection.

On Sep 26, the US Department of Health and Human Services awarded Emergent BioSolutions a $400 million contract to deliver another 18.75 million doses of its Anthrax Vaccine Adsorbed (AVA) to the Strategic National Stockpile of drugs and medical supplies for civilian use.

Federal support for the anthrax countermeasures and vaccine comes from Project BioShield, a $5.6 billion program that Congress established in 2004 to spur the development of medical countermeasures for chemical, biological, radiological, and nuclear weapons by guaranteeing that the government would buy promising products.

After major biotechnology companies showed little interest in the program, last December Congress passed a bill designed to strengthen the program. The bill established the Biomedical Advanced Research and Development Authority within HHS, which can pay contractors when they achieve development milestones, instead of requiring them to deliver finished products before they can receive payment.

See also:

Sep 25 Elusys Therapeutics press release

Sep 27 Emergent BioSolutions press release

Sep 26 CIDRAP News story "HHS orders 18 million doses of anthrax vaccine"

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