Emergent BioSolutions Files IND Application with FDA for Pivitol Anthrax Immune Globulin Clinical Trial
Emergent BioSolutions Files Investigational New Drug Application With FDA for Pivotal Anthrax Immune Globulin Clinical Trial
AIG Program, Supported by NIAID, Expands Company’s Anthrax Biodefense Franchise
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ROCKVILLE, Md.--(BUSINESS WIRE)--Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the company’s Anthrax Immune Globulin (AIG) product candidate. AIG is a therapeutic treatment for patients who present with symptoms of anthrax disease resulting from the release of anthrax toxins into the body.
Pending the standard 30-day FDA review period, the company expects to initiate a pivotal clinical trial in 2007 in order to evaluate AIG safety and pharmacokinetics in 105 healthy volunteers.
“The filing of this IND for our AIG product candidate is a significant step as we continue to expand our anthrax biodefense product franchise, which includes BioThrax® (Anthrax Vaccine Adsorbed), the only FDA-licensed vaccine against anthrax infection, as well as development programs focused on improvements to BioThrax and an enhanced anthrax vaccine,” stated Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “Our AIG product, which we are developing in part with grant funding from the NIAID, is an important element of our efforts to develop safe and effective medical countermeasures to help protect the nation against biological attack.”
The company anticipates that the clinical trial for its AIG candidate will be completed within approximately one year from its commencement date and that no additional clinical trials will be required prior to submitting an application to FDA for marketing approval. The company, which is relying on the FDA animal rule in developing its AIG candidate, expects to conduct pivotal efficacy studies in two animal models, with the timing of those studies dependent upon completion of the development of the models in collaboration with the U.S. government. The company believes that favorable data from these clinical and non-clinical studies would be sufficient to support an application to the FDA for approval of its AIG candidate.
During 2006, the National Institute of Allergy and Infectious Diseases (NIAID) agreed to provide funding to the company of up to $3.7 million to support pivotal animal studies and for the development and validation of product assays.
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of immunobiotics, consisting of 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 immunobiotics for use against biological agents that are potential weapons of bioterrorism. The company’s commercial business is focused on development, manufacture and commercialization of immunobiotics for use against infectious diseases. These immunobiotics are designed to address significant unmet or underserved public health 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, 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.
AIG Program, Supported by NIAID, Expands Company’s Anthrax Biodefense Franchise
http://home.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20070321005304&newsLang=en
ROCKVILLE, Md.--(BUSINESS WIRE)--Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the company’s Anthrax Immune Globulin (AIG) product candidate. AIG is a therapeutic treatment for patients who present with symptoms of anthrax disease resulting from the release of anthrax toxins into the body.
Pending the standard 30-day FDA review period, the company expects to initiate a pivotal clinical trial in 2007 in order to evaluate AIG safety and pharmacokinetics in 105 healthy volunteers.
“The filing of this IND for our AIG product candidate is a significant step as we continue to expand our anthrax biodefense product franchise, which includes BioThrax® (Anthrax Vaccine Adsorbed), the only FDA-licensed vaccine against anthrax infection, as well as development programs focused on improvements to BioThrax and an enhanced anthrax vaccine,” stated Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “Our AIG product, which we are developing in part with grant funding from the NIAID, is an important element of our efforts to develop safe and effective medical countermeasures to help protect the nation against biological attack.”
The company anticipates that the clinical trial for its AIG candidate will be completed within approximately one year from its commencement date and that no additional clinical trials will be required prior to submitting an application to FDA for marketing approval. The company, which is relying on the FDA animal rule in developing its AIG candidate, expects to conduct pivotal efficacy studies in two animal models, with the timing of those studies dependent upon completion of the development of the models in collaboration with the U.S. government. The company believes that favorable data from these clinical and non-clinical studies would be sufficient to support an application to the FDA for approval of its AIG candidate.
During 2006, the National Institute of Allergy and Infectious Diseases (NIAID) agreed to provide funding to the company of up to $3.7 million to support pivotal animal studies and for the development and validation of product assays.
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of immunobiotics, consisting of 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 immunobiotics for use against biological agents that are potential weapons of bioterrorism. The company’s commercial business is focused on development, manufacture and commercialization of immunobiotics for use against infectious diseases. These immunobiotics are designed to address significant unmet or underserved public health 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, 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.
