ROCKVILLE, Md.--(BUSINESS WIRE)--Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has been informed by the National Institute of Allergy and Infectious Diseases (NIAID) that NIAID has cancelled its solicitation for bids that it sought under a request for proposals, RFP NIH-NIAID-DMID-07-05 “Development of a Third Generation Anthrax Vaccine,” due to “programmatic considerations.” The company was one of the respondents to this RFP, which NIAID issued in June 2006.
“Emergent BioSolutions remains committed to developing biodefense countermeasures, including anthrax vaccines and immune globulins,” said Fuad El-Hibri, chairman and chief executive officer. “This cancellation from NIAID does not diminish that commitment. We expect to continue to pursue one or more of the enhancements sought under the RFP, such as room temperature storage, extended shelf life, novel adjuvants and novel delivery systems.”
Since 1998, the company has delivered over 18 million doses of BioThrax® (Anthrax Vaccine Adsorbed) to the U.S. Government in support of the military’s immunization program and the country’s strategic national stockpile effort. The Centers for Disease Control and Prevention (CDC) is currently conducting a multi-year study, commenced in 2002, designed to enhance the current anthrax vaccine by reducing the dose regimen, introducing a second route of administration and extending the booster regimen to potentially three years. The company is also working on expanding the label indication for BioThrax to include its use as a post-exposure prophylaxis. Additional BioThrax enhancement initiatives include dating extension beyond three years and stability studies for room temperature storage.
Continuing, Mr. El-Hibri stated, “Based on the recent Homeland Security Presidential Directive HSPD-18 regarding medical countermeasures against weapons of mass destruction, we believe the U.S. Government remains committed to building a robust biodefense industry in support of protecting the public against Class A bioterror agents, including anthrax, which the U.S. Government has indicated is a top priority. As the manufacturer of the only FDA licensed vaccine for the prevention of anthrax infection, we look forward to continuing to work together with the U.S. Government for the nation’s benefit.”
In addition to BioThrax, the company remains focused on developing its broad product portfolio including an anthrax immune globulin, a botulinum vaccine and immune globulin as well as a typhoid vaccine and hepatitis B therapeutic vaccine, both in Phase II trials, a group B strep vaccine and a chlamydia vaccine. In addition, the company continues to develop a meningitis B vaccine in collaboration with Sanofi Pasteur.
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of immunobiotics, such as vaccines and therapeutics that induce or assist the body’s immune system to prevent or treat disease. The company’s biodefense business is focused on developing and commercializing immunobiotics for use against biological agents that are potential weapons of bioterrorism. The company’s commercial business is focused on developing immunobiotics for use against infectious diseases with significant unmet or underserved medical needs. More information on the company is available at www.emergentbiosolutions.com.
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 ongoing and future development efforts related to anthrax countermeasures, the impact of the NIAID RFP withdrawal, our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management 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 our performance under existing BioThrax® sales contracts with the U.S. government, including the timing of deliveries under these contracts; our ability to obtain new BioThrax® sales contracts with the U.S. government; our plans for future sales of BioThrax®; 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; 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 product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property portfolio; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company’s Registration Statement on Form S-1 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.
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