Consortium signs deal to explore production of tuberculosis vaccine candidate

OXFORD, United Kingdom; ROCKVILLE, Md.; and BERLIN — The Oxford-Emergent Tuberculosis Consortium Ltd., a joint venture between the University of Oxford and Emergent BioSolutions Inc., announced May 5, 2009, the signing of a commercial license agreement with ProBioGen, to evaluate large-scale commercial production capabilities for MVA85A, the consortium’s new TB vaccine candidate.

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 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 CEO 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, CEO of ProBioGen, which is based in Berlin. “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 younger than 1 year old 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.

AGE1.CR.pIX, ProBioGen’s proprietary duck cell line for the production of vaccines and proteins was developed in cooperation with IDT Biologika GmbH to replace embryonated chicken eggs and chicken embryonic fibroblasts as substrate for production of human and animal vaccines.

The Oxford-Emergent Tuberculosis Consortium Ltd. is a joint venture between the University of Oxford and Emergent Product Development UK Ltd. The MVA85A TB vaccine was licensed by Isis Innovation, Oxford's technology transfer company, to the consortium in July 2008.

Emergent BioSolutions is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and therapeutics. Its development pipeline includes programs focused on anthrax, botulism, tuberculosis, typhoid, hepatitis B and Chlamydia. Its BioThrax is the only vaccine licensed by the U.S. Food and Drug Administration for the prevention of anthrax.

The University of Oxford’s Medical Sciences Division is one of the largest biomedical research centers in Europe.