MVA85A is the most clinically advanced of a new generation of TB vaccines under development
OXFORD, England, ROCKVILLE, Md., & NANTES, France--(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 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:
-
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.
-
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.
-
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.
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Source: Emergent BioSolutions Inc.
Emergent BioSolutions
Tracey Schmitt, +1 301 795 1847
Vice
President, Corporate Communications
schmittT@ebsi.com
or
Oxford-Emergent
Tuberculosis Consortium, Ltd.
Dr. Jacqui Shea, +44 118 944 3316
General
Manager
Sheaj@ebsi.com
or
Vivalis
Franck
Grimaud, +33 228 07 37 10
CEO
investors@vivalis.com
Investors
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