BARDA and Emergent BioSolutions Partner to Establish Center for Innovation in Advanced Development and Manufacturing
Contract consists of an 8-year base period of performance, valued at approximately $220 million (Cost-shared between the Government and Emergent) and up to 17 additional 1-year option periods
Plan targets utilization of company's Maryland manufacturing and development facilities in support of pandemic influenza and CBRN programs
ROCKVILLE, Md.--(BUSINESS WIRE)--Jun. 18, 2012-- Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has entered into a public-private partnership 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 (HHS), to establish a Center for Innovation in Advanced Development and Manufacturing (Center). The Center will facilitate advanced development of chemical, biological, radiological, and nuclear (CBRN) medical countermeasures, ensure domestic pandemic influenza vaccine manufacturing surge capacity, share facility construction costs, and provide workforce development training programs to address the U.S. government's preparedness priorities and needs.
"Emergent is pleased to enter into this long-term public-private partnership with BARDA to help achieve our common goal of strengthening national security and preparedness efforts," said Daniel J. Abdun-Nabi, president and chief executive officer of Emergent BioSolutions. "We are honored by the U.S. government's continued confidence in us, which is founded on our longstanding track record of being the premier biodefense developer and supplier of medical countermeasures. This award underscores Emergent's core competencies not only in product development and manufacturing, but also our expertise in contracting with the U.S. government and navigating the regulatory process. This partnership truly allows us the opportunity to fulfill our mission - to protect life."
The contract consists of an eight-year cost-reimbursable, cost-share base period of performance, with a fixed price component, valued at approximately $220 million, with up to 17 additional 1-year options that will specify their own period of performance and contract value. The eight-year base period of performance includes:
Securing a pandemic influenza vaccine candidate and obtaining access to all necessary Intellectual Property rights for facility process development and manufacturing,
Constructing additional facilities to support pandemic influenza vaccine production, and
Obtaining facility licensure to manufacture a pandemic influenza vaccine at the Baltimore facility.
Under the contract, BARDA may issue service task orders for requirements such as CBRN advanced development, pandemic influenza vaccine surge production, facility readiness, and other activities including bulk manufacturing, formulation, filling and finishing, storage, and shipping.
As a designated Center, Emergent is also expected to provide as options under the contract:
Manufacturing and delivery of an influenza vaccine in the event of a pandemic,
Core advanced development and manufacturing services to other commercial partners under contract with the U.S. government for the development of biopharmaceuticals against CBRN threats, and
A workforce development training program to enhance and maintain the U.S.-based ability to produce identified medical countermeasures.
The establishment of Centers that could provide advanced development and manufacturing capabilities for CBRN medical countermeasures to address national security and to augment public health needs on a cost-effective, reliable and sustainable basis is a response to the strategic imperative by HHS to have the "nimble, flexible capacity to produce medical countermeasures rapidly in the face of any attack or threat, known or unknown, including a novel, previously unrecognized, naturally occurring emerging infectious disease." This BARDA initiative addresses a gap that was identified during the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) review led by HHS Assistant Secretary for Preparedness and Response and is one of the critical elements in HHS' forward-looking strategy published in an August 2010 report, The Public Health Emergency Medical Countermeasures Review: Transforming the Enterprise to Meet Long-Range National Needs.
This contract was awarded through HHS Solicitation No. 11-100-SOL-00011, funded 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. Follow us on twitter @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, 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 Investor 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