ROCKVILLE, Md.--(BUSINESS WIRE)--Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has received a contract from the Department of Health and Human Services (HHS) for over $24.3 million to fund the further development of Emergent’s anthrax monoclonal antibody AVP-21D9. This contract will be jointly administered through the Office of the Biomedical Advanced Research and Development Authority (BARDA), and the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH). The four year contract provides funding for scale-up of the manufacturing process, for non-clinical studies, and for a Phase I clinical trial. Emergent anticipates that it will receive approximately $20 million over the first two contract years in support of the scale-up of the manufacturing process and the completion of a Phase I clinical trial. Emergent expects to focus on completing certain non-clinical studies during the final two years of the contract.
“We are very pleased to have secured this important contract with HHS. The AVP-21D9 antibody is a fully human antibody that has demonstrated very high affinity to the anthrax toxin in animal studies and shows great promise as an effective post-exposure anthrax therapeutic. We believe this funding from HHS underscores the U.S. government’s commitment to a multi-prong approach in responding to the threat of bioterrorism in our country. We are certainly encouraged that we were able to secure this contract so soon following our acquisition of AVP-21D9 earlier this year,” said Stephen Lockhart, senior vice president, product development of Emergent BioSolutions.
The continued development of this anthrax monoclonal antibody candidate further solidifies Emergent’s franchise of anthrax countermeasures, which now includes:
BioThrax® – the only FDA-approved vaccine to prevent anthrax. More than two million men and women of the United States military have received the vaccine, and HHS has procured more than 28 million doses of BioThrax for the SNS;
rPA – a recombinant anthrax vaccine candidate, which is composed of a purified protein with an aluminum adjuvant and is designed to induce antibodies that neutralize anthrax toxins;
AV7909 – an anthrax vaccine candidate composed of BioThrax® and the immunostimulatory oligodeoxynucleotide compound CPG 7909 (VaxImmune®), licensed from Pfizer Inc;
AIG – a polyclonal anthrax immunoglobulin product candidate being developed as an intravenous post-exposure treatment for patients who present with symptoms of anthrax disease, AIG is derived from human plasma from individuals who have been vaccinated with BioThrax.
This project has been funded in whole or in part with Federal funds from the Biomedical Advanced Research and Development Authority (BARDA), Department of Health and Human Services, and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272200800040C and from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Grant No. U01AI070493-01.
About the AVP-21D9 anthrax monoclonal antibody candidate
AVP-21D9 is a fully human anthrax monoclonal antibody that appears to be a highly active therapeutic for anthrax based on laboratory and animal studies conducted to date. This could be due to its putative mechanism of action compared to other monoclonal candidates under development - binding to protective antigen and inhibiting heptamer (pore) formation, rather than inhibiting binding of toxin to its receptor. Based on non-clinical studies in mice, rats, and rabbits, AVP-21D9 provides a high level of protection even in animals with clinical symptoms of anthrax. These studies indicate that AVP-21D9 has the potential to be a life-saving medical countermeasure and to fill an important unmet need. AVP-21D9 was acquired from Avanir Pharmaceuticals (Nasdaq:AVNR) in March 2008, which advanced the technology through proof-of-concept studies and clinical-scale manufacturing funded by a NIAID grant.
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 targeting anthrax, botulism, typhoid, tuberculosis and hepatitis B. 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. There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including the timing of, and the potential for successful outcomes resulting from future product development efforts and our ability to obtain additional funding from the U.S. government for them, 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.
Emergent BioSolutions Inc.
Robert G. Burrows
Vice President, Investor Relations
Director, Corporate Communications