U.S. Government Issues Declaration Covering Emergent BioSolutions' BioThrax® and Anthrax Immune Globulin under Prep Act
HHS Secretary Determines That Potential Threat of Exposure to Anthrax Constitutes a Public Health Emergency
ROCKVILLE, Md.--(BUSINESS WIRE)--October 9, 2008--Emergent BioSolutions Inc. (NYSE: EBS) announced today that two medical countermeasures included in its anthrax franchise -- BioThrax® (Anthrax Vaccine Adsorbed) and Anthrax Immune Globulin (AIG) -- have been included as covered countermeasures under the Public Readiness and Emergency Preparedness Act (PREP Act) pursuant to a declaration issued by the U.S. Department of Health and Human Services (HHS). In issuing this declaration, the Secretary of HHS determined that there is a credible risk that the threat of exposure to anthrax and the resulting disease constitutes a public health emergency. The declaration will remain in effect until December 31, 2015. BioThrax is the only vaccine licensed by the U.S. Food and Drug Administration for the prevention of anthrax infection.
This HHS declaration under the PREP Act provides liability protections to activities related to developing, manufacturing, distributing, prescribing, dispensing, administering and using both of the company's anthrax medical countermeasures in preparation for, and in response to, a potential anthrax attack. In addition to this declaration, in 2006 BioThrax was certified under the Support Anti-Terrorism by Fostering Effective Technology Act (the "SAFETY Act"), which Congress enacted to encourage the development and deployment of anti-terrorism technologies by providing certain liability protections for providers of qualified anti-terrorism technologies for claims arising out of acts of terrorism.
"This PREP Act declaration is further evidence of the U.S. Government's commitment to our efforts to develop a portfolio of medical countermeasures to address the threat to public health posed by the use of anthrax as a weapon of biological warfare," said Daniel J. Abdun-Nabi, president of Emergent BioSolutions. "As a long term supplier of BioThrax to the Department of Defense and the Department of Health and Human Services, and as a developer of new medical countermeasures for the prevention and treatment of anthrax infection, we take very seriously our role in cooperating with the U.S. Government to address this threat."
About Anthrax Immunoglobulin (AIG)
Emergent BioSolutions is developing an anthrax immune globulin (AIG) product candidate as a single dose intravenous therapeutic for treatment of patients with manifest symptoms of anthrax disease resulting from the release of anthrax toxins into the body. If successfully developed, it is expected the AIG therapeutic will be prescribed for administration either as a monotherapy or in conjunction with an antibiotic. Emergent BioSolutions has obtained National Institute of Allergy and Infectious Diseases (NIAID) grant funding to support non-clinical safety and efficacy studies and clinical trial planning.
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a leading biopharmaceutical company dedicated to one simple mission-to protect life. Emergent develops, manufactures and commercializes immune-related biologics, vaccines and biotherapeutics that assist the body's immune system to prevent or treat infectious and other life threatening diseases. Emergent's marketed product, BioThrax® (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection. Emergent's clinical pipeline includes programs focused on anthrax, botulism, typhoid, tuberculosis, hepatitis B and chlamydia. www.emergentbiosolutions.com.
Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, including our expected revenue growth and net earnings for 2008, and any other statements containing the words "believes", "expects", "anticipates", "plans", "estimates" and similar expressions, are forward-looking statements. materially from those indicated by such forward-looking statements, including our ability to obtain new BioThrax sales contracts with the U.S. government; our plans for future sales of BioThrax; future appropriations for the procurement of BioThrax for the SNS; future appropriations for the funding of development contracts related to our other anthrax-related programs; our plans to pursue label expansions and improvements for BioThrax; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; the timing of and our ability to obtain and maintain regulatory approvals for our other product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company's current report on Form 10-Q for the quarter ended June 30, 2008 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.