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|Emergent BioSolutions Initiates Final Pivotal Study to Support Licensure of BioThrax at Large Scale|
The primary objectives of this randomized, observer-blinded study are to demonstrate consistency of three BioThrax vaccine lots manufactured in Building 55 based on lot-to-lot equivalence as well as to demonstrate comparability of the three Building 55 lots with a Building 12 lot based on non-inferiority.
Building 12 produces 7 to 9 million doses of BioThrax annually. Building
55 has the potential to triple manufacturing capacity to an estimated 20
to 25 million doses annually. Both facilities are located on Emergent’s
This program is fully funded, up to
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, prospects, plans, objectives, and degree of confidence of management, and any other statements containing the words “believes”, “expects”, “anticipates”, “intends”, “plans”, “estimates” and similar expressions, are forward-looking statements. 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.
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 appropriations for BioThrax® procurement;
our ability to obtain new BioThrax sales contracts or modifications to
existing contracts; availability of funding for our U.S. government
grants and contracts; the timing of and our ability to obtain and
maintain approval for Building 55; and our manufacturing capabilities
and strategy. 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
Emergent BioSolutions Inc.