Emergent BioSolutions (NYSE:EBS) announced today that, after completion of an inter-agency In Process Review, the Biomedical Advanced Research Development Authority (BARDA) of the U.S. Department of Health and Human Services (HHS) has exercised a contract option to further advance the development of PreviThraxTM (Recombinant Protective Antigen Anthrax Vaccine, Purified), the company’s novel rPA anthrax vaccine candidate. This option is part of the company’s rPA development contract with BARDA executed in October 2010.
“Emergent is pleased that PreviThrax, our rPA vaccine candidate, has met all of the key milestones necessary for BARDA to exercise the contract option,” said Adam Havey, executive vice president of Emergent BioSolutions. “We look forward to continuing to work with BARDA to develop the medical countermeasures it believes are necessary to address the nation’s security requirements.”
Since initiating the contract in 2010, Emergent has made significant progress in the development of PreviThrax, including:
- Increasing the manufacturing yield by over fourfold,
- Transferring the manufacturing process to single-use bioreactors for flexible manufacturing,
- Transferring the manufacturing process to the company's Baltimore manufacturing facility,
- Demonstrating stability for both liquid and dry formulations,
- Demonstrating stability at elevated temperatures, and
- Completing numerous analytical method validations.
This work is being performed under Contract Number HHSO100201000059C, funded by BARDA. The vaccine candidate is based on the pioneering work of the U.S. Army Medical Research Institute of Infectious Diseases and has previously received funding from the National Institute of Allergy and Infectious Diseases.
About Emergent BioSolutions Inc.
Emergent BioSolutions protects and enhances life by developing and manufacturing vaccines and therapeutics that are supplied to healthcare providers and purchasers for use in preventing and treating disease. Emergent’s marketed and investigational products target infectious diseases, oncology and autoimmune disorders. Additional information about the company may be found at www.emergentbiosolutions.com. Follow us on Twitter @emergentbiosolu.
Safe Harbor Statement
This press release includes statements that are forward-looking. These forward-looking statements include those regarding our expectations for PreviThrax. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances.
Some important factors that could cause our actual results to differ from our expectations in these forward-looking statements include: appropriations for and our ability to win development contracts with the U.S. government for PreviThrax and the inherent uncertainty of the timing, success of, and expense associated with development, clinical utility, regulatory approval and potential government procurement of PreviThrax. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the SEC, when evaluating our forward-looking statements.