Emergent BioSolutions Secures Additional Funding from BARDA to Pursue Post-Exposure Prophylaxis Indication for BioThrax
BARDA to provide additional funding of up to $8.43 million to conduct a non-interference study to support licensure of BioThrax® (Anthrax Vaccine Adsorbed) for Post-Exposure Prophylaxis
Company is ahead of schedule in a separate pivotal study that is evaluating a three-dose BioThrax regimen for Post-Exposure Prophylaxis
ROCKVILLE, Md.--(BUSINESS WIRE)--Jun. 4, 2012-- Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has reached an agreement with the Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, to conduct a non-interference study to be used to support a Post-Exposure Prophylaxis (PEP) indication for BioThrax® (Anthrax Vaccine Adsorbed). This agreement provides the company with up to $8.43 million in additional funding. The non-interference trial, targeted to commence in the fourth quarter of 2012, is expected to involve 120 healthy volunteers and is designed to demonstrate non-interference of BioThrax when administered in conjunction with antibiotics. Approval of a PEP indication would enable BioThrax to be used in combination with antibiotics in people suspected to have been exposed to anthrax spores. Currently, BioThrax only has a pre-exposure prophylaxis indication.
Separately, under its development contract with BARDA, Emergent has completed dosing and the last subject visit in a pivotal PEP immunogenicity and safety study evaluating a three-dose vaccination schedule for BioThrax. Data from this study, which involves 200 healthy volunteers, will also be used by the company in support of a PEP indication for BioThrax. The company anticipates preliminary data from this study will be available in the fourth quarter of 2012.
These studies are fully funded under contract number HHSO100200700037C, provided by the Biomedical Advanced Research and Development Authority of the Department of Health and Human Services.
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