MVA85A is the most clinically advanced of a new generation of TB vaccines under development
OXFORD, England, ROCKVILLE, Md. & BERLIN--(BUSINESS WIRE)--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 ProBioGen, 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 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.
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.
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.
Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=5956499&lang=en
Source: Emergent BioSolutions Inc.
Oxford-Emergent Tuberculosis Consortium, Ltd.
Dr. Jacqui Shea, +44
118 944 3316
General Manager
Sheaj@ebsi.com
or
Emergent
BioSolutions
Tracey Schmitt, +1 301 795 1847
Vice
President, Corporate Communications
schmittT@ebsi.com
or
ProBioGen
AG
Dr. Gertraud Unterrainer, +49 30 92400610
Chief
Financial Officer
Gertraud.unterrainer@probiogen.de
Investors
View printer-friendly version