Oxford-Emergent Tuberculosis Consortium signs commercial license agreement with Probiogen to explore production of MVA85A TB vaccine candidate using AGE1.CR.pIX® cell line
MVA85A is the most clinically advanced of a new generation of TB vaccines under development
Under the commercial agreement, the Consortium will explore production of MVA85A using the ProBioGen proprietary AGE1.CR.pIX® cell line, which was developed to replace chicken embryonic fibroblasts (CEF) and chicken eggs as production substrates for vaccines.
"We are pleased that the Oxford-Emergent Tuberculosis Consortium is able to work with ProBioGen to evaluate production of MVA85A, the most clinically advanced TB vaccine candidate," said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. "This agreement represents a step forward in addressing an unmet medical need and is a sign of progress that supports our company mission - to protect life."
"ProBioGen is well positioned to provide the Oxford-Emergent Tuberculosis Consortium an innovative solution to produce their MVA-based, clinically advanced vaccine" said Michael Schlenk, chief executive officer of ProBioGen. "Our proprietary AGE1.CR.pIX® cell line that we have developed in cooperation with our partner IDT Biologics is a new state-of-the-art technology that provides outstanding productivity and the highest level of characterization."
The Consortium recently announced the commencement of a Phase IIb clinical trial to evaluate MVA85A in approximately 2,784 children less than one year of age in South Africa. It is expected that the trial will generate important safety, immunogenicity and preliminary efficacy data about the vaccine candidate.
The commercial license includes an upfront payment to ProBioGen as well as development milestone payments and royalties on future sales of the TB candidate.
The Oxford-Emergent Tuberculosis Consortium Ltd. (OETC) is a joint venture between the University of Oxford and Emergent Product Development UK Ltd. OETC was formed with the aim of developing the MVA85A TB vaccine to meet both developed and developing country health needs. The vaccine was licensed by Isis Innovation, Oxford's technology transfer company, to the Consortium in July 2008.
Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and therapeutics that assist the body's immune system to prevent or treat disease. Emergent's marketed product, BioThrax® (Anthrax Vaccine Adsorbed), is the only vaccine licensed by the U.S. Food and Drug Administration for the prevention of anthrax. Emergent's development pipeline includes programs focused on anthrax, botulism, tuberculosis, typhoid, hepatitis B and chlamydia. Additional information may be found at www.emergentbiosolutions.com.
The University of Oxford's Medical Sciences Division is one of the largest biomedical research centers in Europe. It represents almost one-third of Oxford University's income and expenditure, and two-thirds of its external research income. Oxford's world-renowned global health program is a leader in the fight against infectious diseases (such as malaria, HIV/AIDS, tuberculosis and avian flu) and other prevalent diseases (such as cancer, stroke, heart disease and diabetes).
Key to its success is a long-standing network of dedicated Wellcome Trust-funded research units in Asia (Thailand, Laos and Vietnam) and Kenya, and work at the MRC Unit in The Gambia. Long-term studies of patients around the world are supported by basic science at Oxford and have led to many exciting developments, including potential vaccines for tuberculosis, malaria and HIV, which are in clinical trials. www.medsci.ox.ac.uk
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 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 actual results of the Consortium or Emergent to differ materially from those indicated by such forward-looking statements, including the timing of, and the potential for successful outcomes resulting from, future product development efforts; the ability of the Consortium or Emergent to obtain additional funding for product development efforts; plans of the Consortium and Emergent to expand manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of products; and other factors identified in Emergent's annual report on Form 10-K for the year ended December 31, 2008 and subsequent reports filed with the SEC. The Consortium and Emergent disclaim any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
ProBioGen is a leading cell specialist. By combining deep molecular understanding of cells with state-of-the-art industry process engineering and production know-how, ProBioGen's technologies enable biopharmaceutical companies to develop products with superior efficiency, safety and a more favorable cost profile. The company is headquartered in Berlin. AGE1.CR.pIX®, ProBioGen's proprietary duck cell line for the production of vaccines and proteins has been developed by ProBioGen in cooperation with IDT Biologika GmbH to replace embryonated chicken eggs and chicken embryonic fibroblasts as substrate for production of human and animal vaccines. This cell line fully supports the production of a wide spectrum of wild-type and recombinant viruses, including highly attenuated poxviruses. Additional information at www.probiogen.de.
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