Public healthNew $186.6 million contract shows anthrax threat real

A less-dangerous cutaneous anthrax lesion // Source: bepast.org

A new multimillion-dollar government contract for a Maryland biological security research company indicates the threat of an anthrax outbreak as a result of bioterrorism remains a major priority for the Obama administration.

Emergent BioSolutions Inc., which has headquarters in Rockville, Maryland, said it signed a contract valued at up to $186.6 million with the Biomedical Advanced Research and Development Authority of the Department of Health and Human Services. The contract will enable the company to develop a recombinant protective antigen anthrax vaccine, which is likely to produce a more rapid response to anthrax infection than existing vaccines.

Anthrax when inhaled and left untreated has a fatal outcome in humans.

The bacillus presents a bioterrorism threat partly because of recent history of its use in the United States and partly because, in spore form, anthrax stays very stable in the environment and is difficult to eradicate.

UPI reports that a rash of anthrax scares disrupted government operations in various parts of the United States several times after the 9/11 attacks, right up to 2009. Anthrax incidents soon after those attacks killed at least five people and infected seventeen others but were found to be unrelated to the hijackers. The suspected perpetrator, biodefense researcher Bruce Ivins, killed himself in July 2008.

Several anthrax scares in 2009 caused major alerts, costing the government millions of dollars in precautionary and preventive measures.

The emphasis on producing a rapid-response anthrax vaccine showed the government was set to back up advanced biological defense industries that could respond to any unforeseeable eventuality involving anthrax, analysts said.

“We applaud the U.S. government’s commitment to the biodefense industry and to the development of additional medical countermeasures using multiple technologies and additional sites to address the acknowledged anthrax threat,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions.

He said the contract would strengthen Emergent’s anthrax franchise and reaffirm the company’s position “as a leading supplier to, and developer for, the U.S. government of anthrax biomedical countermeasures.”

El-Hibri said, “We are enthusiastic about the role we serve in addressing this need and in creating jobs and expanding economies within the local communities where we operate.”

The contract covers five years of cost plus a fixed fee for development.

Emergent said it would conduct a range of studies, including those for formulation and stability, a clinical study and non-clinical efficacy studies, process validation, as well as consistency lot manufacture.

Emergent has developed this comprehensive plan as a foundation to advance its rPA anthrax vaccine candidate in preparation for pivotal studies that would potentially lead to licensure application with the U.S. Food and Drug Administration (see “Emergent sells anthrax vaccine to U.S. allies,” 25 June 2010 HSNW).

The company anticipates recognizing revenues from the award in the fourth quarter of 2010 of approximately $2 million with no major impact on pretax earnings.

Emergent’s rPA anthrax vaccine candidate is a purified recombinant protective antigen protein formulated with an alum adjuvant and is designed to induce antibodies that neutralize anthrax toxins.

It is based on the pioneering work of the U.S. Army Medical Research Institute of Infectious Diseases and has been the subject of two research and development grants for a total of about $100 million by the National Institute of Allergy and Infectious Diseases.