Emergent BioSolutions Inc.
Emergent BioSolutions Announces Primary Endpoints Met in Pivotal Study Supporting Licensure of Building 55
GAITHERSBURG, Md., Feb. 13, 2015 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) today announced completion of the in-life phase of the pivotal nonclinical efficacy study designed to demonstrate that BioThrax® (Anthrax Vaccine Adsorbed) manufactured at large scale in the company’s new modern facility, Building 55, is comparable to the BioThrax currently manufactured in its approved facility, Building 12. Interim analysis has shown that the primary endpoints were met; these include demonstrating comparability to vaccine manufactured in Building 12 as well as consistency between lots manufactured in Building 55. Data from this study will be used to support a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for licensure of Building 55. BioThrax is the only FDA-licensed vaccine for the prevention of anthrax disease.
Adam Havey, executive vice president and president biodefense division at Emergent BioSolutions, stated, “The Building 55 scale-up program represents years of collaborative effort with BARDA and FDA to meet the U.S. government’s stated requirement of 75 million doses in the Strategic National Stockpile. Emergent is pleased with the completion of the in-life phase of our pivotal study. The remainder of 2015 will entail finalizing the nonclinical pivotal study report, progressing efforts related to the Prior Approval Inspection of the Lansing facility, and compiling the sBLA. We are continuing to work with FDA and anticipate approval in either late 2015 or early 2016.”
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 Lansing, Michigan campus.
This program is fully funded at $104 million under contract number HHSO100201000034C by the Biomedical Advanced Research and Development Authority within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.
About Emergent BioSolutions
Emergent BioSolutions is a global specialty biopharmaceutical company seeking to protect and enhance life by offering specialized products to healthcare providers and governments to address medical needs and emerging health threats. Additional information about the company may be found at www.emergentbiosolutions.com. Follow us @emergentbiosolu.
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 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 SEC, when evaluating our forward-looking statements.
CONTACT: Investor Contact:
Robert G. Burrows
Vice President, Investor Relations
240-631-3280
BurrowsR@ebsi.com
Media Contact:
Tracey Schmitt
Vice President, Global Public Affairs and
Corporate Responsibility
240-631-3394
SchmittT@ebsi.com