OXFORD, UK and ROCKVILLE, MD and NANTES, FRANCE–(Marketwire – May 6, 2009) – Oxford- Emergent Tuberculosis Consortium signs commercial license agreement with vivalis to eXPLORE production of MVA85A tb vaccine candidate USING EB66® CELL LINE
MVA85A is the most clinically advanced of a new generation of TB vaccines under development
OXFORD, UK; ROCKVILLE, MD, USA; NANTES, FRANCE – May 5, 2009 – The Oxford- Emergent Tuberculosis Consortium Ltd., a joint venture between the University of Oxford and Emergent BioSolutions Inc. (NYSE: EBS), announced today the signing of a commercial license agreement with Vivalis (NYSE- EuroNext:VLS) to evaluate large scale commercial production capabilities for MVA85A, the Consortium’s promising new TB vaccine candidate.
Under the commercial agreement, the Consortium will explore production of MVA85A using the Vivalis proprietary EB66® cell line, which is derived from duck embryonic stem cells. This cell line possesses unique industrial and regulatory characteristics such as long term genetic stability and immortality, growth in serum free medium, and proliferation at high cell densities in suspension.
“We are pleased that the Oxford-Emergent Tuberculosis Consortium was able to enter into this agreement with Vivalis to support the production of MVA85A, the most clinically advanced TB vaccine candidate targeting one of the world’s deadliest diseases,” said Fuad El-Hibri , chairman and chief executive officer of Emergent BioSolutions. “This license is a further step towards addressing an unmet medical need and supportive of our company mission – to protect life.”
“Vivalis is proud to be selected by the Oxford-Emergent Tuberculosis Consortium to advance their MVA-based vaccine” said Franck Grimaud, chief executive officer of Vivalis. “Our EB66® cell line is recognized by a large majority of vaccine developers and this agreement adds the Consortium to our growing list of customers proving our cell line is a serious contender for biologics production.”
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 Vivalis 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.
Vivalis (NYSE-Euronext: VLS) is a biopharmaceutical company that provides innovative cell-based solutions to the pharmaceutical industry for the manufacture of vaccines and proteins, and develops drugs for the prevention and treatment of viral diseases. Vivalis expertise and intellectual property are exploited in three main areas:
1. The development and manufacturing of vaccines. Vivalis offers research and commercial licenses for its EB66® cell line, derived from duck embryonic stem cells, to pharmaceutical and biotechnology companies for the production of viral vaccines. Vivalis receives up front, milestones, and royalties on its licensee’s net sales.
2. The development of production systems for recombinant proteins and monoclonal antibodies. Vivalis licenses its EB66® cell line for the production of recombinant proteins to biotechnology and pharmaceutical companies. Vivalis receives up front, milestones, and royalties on its licensees’ net sales.
3. The construction of a portfolio of proprietary products in the area of vaccines and anti-viral molecules (hepatitis C).
Based in Nantes (France), Vivalis was founded in 1999 by the Grimaud group (1,450 employees), the second largest group worldwide in animal genetic selection. Vivalis has established more than 25 partnerships with world leaders in this sector. Vivalis is a member of the French ATLANTIC BIOTHERAPIES bio-cluster.
Learn more about Vivalis at www.vivalis.com
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.
