Emergent BioSolutions Receives FDA Approval for BioThrax Administered Intramuscularly in a Three-Dose Primary Series Followed by Booster Doses
ROCKVILLE, Md.--(BUSINESS WIRE)--May. 17, 2012-- Emergent BioSolutions Inc. (NYSE: EBS) announced today that the U.S. Food and Drug Administration (FDA) has approved its supplemental Biologics License Application (sBLA) to change the administration schedule of BioThrax® (Anthrax Vaccine Adsorbed) to a three-dose primary series of intramuscular injections at 0, 1, and 6 months. The booster series consists of intramuscular injections at 12 and 18 months after initiation of the primary series, and at 1-year intervals thereafter for those who remain at risk. Individuals are not considered protected until they have completed the three-dose primary immunization series. BioThrax is the only FDA-licensed vaccine for pre-exposure protection of adults against anthrax disease.
"Emergent applauds the Centers for Disease Control and Prevention (CDC) for their dedicated research to optimize the dosing schedule of BioThrax and the FDA for a timely review and approval process. Achieving this milestone is a testament to our continued efforts to advance BioThrax," said Daniel J. Abdun-Nabi, president and chief executive officer of Emergent BioSolutions. "We are pleased that the U.S. government shares our commitment to enhance the utility of BioThrax and its attractiveness as protection for military personnel deployed in high risk areas."
The sBLA was based on a Final Study Report from a large multi-center study initiated by the CDC in 2002. This study was designed to evaluate whether as few as three doses of BioThrax administered over six months, with booster doses to follow, would confer an adequate immune response. CDC completed the study in 2009, and Emergent submitted the sBLA in 2010.
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 http://www.emergentbiosolutions.com.
BioThrax is the only FDA-licensed vaccine for the prevention of anthrax disease. It is indicated for the active immunization of adults who are at high risk of exposure to anthrax. The safety and efficacy of BioThrax in a post-exposure setting have not been established. Individuals are not considered protected until they have completed the three-dose primary immunization series. Vaccination with BioThrax may not protect all individuals.
BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of Bacillus anthracis. To date, Emergent has delivered over 55 million doses of BioThrax to the U.S. government and continues to deliver additional doses under active procurement contracts. Since 1998, over 11 million doses have been administered to more than 2.7 million military personnel. For full prescribing information, please visit http://www.biothrax.com/prescribinginformation_biothrax_us.pdf.
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 any potential future securities offering, our expected revenue growth and net earnings for 2012, 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 appropriations for BioThrax® procurement; our ability to obtain new BioThrax® sales contracts; 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 success of our ongoing and planned development programs, preclinical studies and clinical trials; our ability to identify and acquire or in license products and product candidates that satisfy our selection criteria; the potential benefits of our existing collaboration agreements and our ability to enter into selective additional collaboration arrangements; 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2012 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.
Source: Emergent BioSolutions Inc.
Emergent BioSolutions Inc. Investors Contact: Robert G. Burrows Vice President, Investor Relations 301-795-1877 BurrowsR@ebsi.com or Media Contact: Tracey Schmitt Vice President, Corporate Communications 301-795-1800 SchmittT@ebsi.com