23.07.2008 04:05:00
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Emergent BioSolutions and the University of Oxford Form Joint Venture to Develop an Advanced Tuberculosis Vaccine with Funding from Wellcome Trust and Aeras Global TB Vaccine Foundation
The University of Oxford and Emergent BioSolutions Inc. (NYSE:EBS)
announced today that they have formed a joint venture, The
Oxford-Emergent Tuberculosis Consortium Ltd. (the "Consortium”),
to further develop MVA85A, the world’s most
clinically advanced vaccine candidate for the prevention of
tuberculosis. The University of Oxford, through its technology transfer
office, Isis Innovation Limited, has exclusively licensed the MVA85A
tuberculosis vaccine candidate and related technology to the Consortium.
The Consortium will work with the Aeras Global TB Vaccine Foundation to
evaluate the efficacy of MVA85A in infants in a Phase IIb clinical trial
anticipated to begin in 2009. The trial will take place at a clinical
trial site developed by Aeras and the University of Cape Town’s
South African Tuberculosis Vaccine Initiative (SATVI) in Worcester,
South Africa. The Consortium has secured £8
million (approximately $16 million) from The Wellcome Trust and the
Aeras Global TB Vaccine Foundation to fund this Phase IIb trial. Under
agreements with the Consortium, Emergent BioSolutions has the rights to
commercialize the MVA85A vaccine. The Aeras Global TB Vaccine Foundation
will have distribution rights in the developing world to ensure
availability and access to the vaccine to those who need it.
The MVA85A vaccine candidate is designed to work in tandem with the
Bacille Calmette Guerin vaccine (BCG), which is currently the only
available vaccine against tuberculosis. BCG is administered to infants
throughout the developing world and in certain countries in the
developed world. However, BCG provides only variable protection against
pulmonary tuberculosis and is not effective in adults.
The MVA85A vaccine candidate is intended to augment the response of
T-cells already primed by the BCG vaccine. Clinical trials to date have
demonstrated consistently high cellular immune responses in those who
received the MVA85A vaccine candidate following vaccination with BCG.
The MVA85A vaccine has been awarded orphan drug status by EMEA and is
the most clinically advanced of a new generation of tuberculosis vaccine
candidates.
The MVA85A vaccine was originally developed at the University of Oxford
by Dr. Helen McShane, a Wellcome Trust Senior Clinical Research Fellow,
working with Dr. Sarah Gilbert and Professor Adrian Hill, a Wellcome
Trust Principal Research Fellow. Further funding has been provided by
the European Community's fifth and sixth Framework Programmes and the
Medical Research Council (MRC), a UK organization dedicated to promoting
the balanced development of medical and related biological research in
the UK.
"I am excited by the prospect of further
development of this promising vaccine candidate,”
said Dr. McShane of the University’s Jenner
Institute. "Curbing tuberculosis is a pressing
global health priority, and if achieved could save the lives of
millions. We at Oxford have selected Emergent BioSolutions as our
commercial partner given their vaccine development experience and
dedication to bringing lifesaving vaccines to market.”
Mauro Gibellini, senior vice president corporate development, Emergent
BioSolutions, said, "This unique
public-private partnership provides Emergent BioSolutions with an
extraordinary opportunity to address a major public health crisis. We
believe that by pooling our resources and expertise with such
distinguished academic and charitable peers, this consortium is
well-positioned to develop what would be a groundbreaking vaccine to
prevent one of the world’s most widespread
diseases and tragic causes of death.”
Dr. Ted Bianco, Director of Technology Transfer at the Wellcome Trust,
said, "We have been losing the battle against tuberculosis for too long,
as a result of poor diagnostics, protracted treatment regimes,
antibiotic resistance and HIV-induced, immuno-suppression. Conquering
this historic enemy has to be one of our highest public health
priorities, and developing an effective vaccine is arguably the key to a
defensive strategy that will ultimately turn the tide in this insidious
war. It is first class science that has brought us this new hope, and it
will be first-class partnering that takes us to the next stage. I
applaud Dr. McShane and her colleagues for their tireless efforts.”
"New tuberculosis vaccines are urgently needed. A vaccine that is
effective in all ages against all forms of the disease could have an
enormous global public health impact by arresting the continued
expansion of this terrible epidemic," said Jerald C. Sadoff, MD, the
President and CEO of the Aeras Global TB Vaccine Foundation. "Leading
scientists at the University of Oxford have been working on a novel
vaccine candidate for infants and adolescents. I am encouraged by the
support given to Oxford’s efforts by The
Wellcome Trust and Emergent BioSolutions,”
Dr. Sadoff said. "Aeras is pursuing this
vaccine and other promising candidates. We will support MVA85A in
expanded Phase II efficacy trials and in the use of Aeras-sponsored
Phase III field sites if MVA85A meets all of the established criteria
for such trials.”
About Tuberculosis
Tuberculosis, which is caused by the Mycobacterium tuberculosis
bacterium, is the world’s second leading
cause of death from infectious disease in adults, after HIV/AIDS,
according to the World Health Organization. Over one third of the world’s
population is infected with the disease, and an estimated 1.7 million
people die of tuberculosis every year. One of ten people infected will
develop the active form of the disease during their lifetime.
Drug-resistant strains including multi-drug resistant TB and extensively
drug-resistant TB are on the rise, raising concerns about the efficacy
of the current BCG vaccine and leaving many patients without effective
treatment. This year, the World Health Organization reported the highest
rates of multi-drug resistant tuberculosis ever recorded.
The increased susceptibility to tuberculosis seen in people infected
with HIV is having a devastating impact, particularly in sub-Saharan
Africa. The number of new cases of tuberculosis has more than doubled in
countries with high HIV prevalence in the past 15 years. Tuberculosis is
the most common cause of death in people living with HIV in Africa and a
major cause of death elsewhere.
Tuberculosis is a global problem, infecting millions worldwide. In the
United States, where there is currently no licensed vaccine,
tuberculosis rates in the United States are declining. However, efforts
to strengthen and intensify tuberculosis prevention, treatment and
control are still urgently needed to address this global pandemic.
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a leading biopharmaceutical company
dedicated to one simple mission—to protect
life. We develop, manufacture and commercialize vaccines and
therapeutics that assist the body’s immune
system to prevent or treat disease. Our products target infectious
diseases and other medical conditions that have resulted in significant
unmet or underserved public health needs. Our marketed product, BioThrax®
(Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S.
Food and Drug Administration for the prevention of anthrax infection.
More information on the company is available at www.emergentbiosolutions.com.
About Oxford University’s Medical Sciences
Division
Oxford University’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.
About the Wellcome Trust
The Wellcome Trust is the largest charity in the UK. It’s
mission is to fund innovative biomedical research, in the UK and
internationally, spending around £600 million
each year to support the brightest scientists with the best ideas. The
Wellcome Trust supports public debate about biomedical research and its
impact on health and wellbeing. www.wellcome.ac.uk
About Aeras Global TB Vaccine Foundation
The Aeras Global TB Vaccine Foundation (http://www.aeras.org)
is a non-profit organization working as a Product Development
Partnership to develop new tuberculosis vaccines and ensure that they
are distributed to all who need them around the world. Aeras
collaborates with academia, industry, foundations and governments to
develop new TB vaccine candidates and delivery systems, manufacture
vaccines at low cost and establish intellectual property rights to
assure their future availability and affordability. Aeras is funded by
the Bill & Melinda Gates Foundation, the Netherlands Ministry of Foreign
Affairs, the Danish International Development Agency, the Research
Council of Norway and the U.S. Centers for Disease Control and
Prevention. Aeras, with over 130 employees, is based in Rockville,
Maryland, where it operates a state-of-the-art manufacturing and
laboratory facility.
About SATVI
The South African Tuberculosis Vaccine Initiative is located in the
Institute of Infectious Disease and Molecular Medicine at the University
of Cape Town (UCT). Since 1999, with funding largely from the Aeras
Global TB Vaccine Foundation, SATVI has developed the capacity to
conduct registration standard vaccine trials at a site in Worcester,
where rates of tuberculosis are amongst the highest in the world. SATVI
has a state of the art immunology laboratory where it conducts cutting
edge basic science research aimed at better understanding the human
immune response to tuberculosis and to tuberculosis vaccines. SATVI has
also conducted a number of very large field trials and epidemiological
cohort studies, which are necessary to test the efficacy of new
tuberculosis vaccines. http://www.satvi.uct.za
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 our strategy, future operations, future financial
position, future revenues, projected costs, prospects, plans and
objectives of management, including our expected revenue growth and net
earnings for 2008, 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 company’s
actual results to differ materially from those indicated by such
forward-looking statements, including the joint venture’s
ongoing and planned development programs; the clinical utility of
MVA85A; the timing of, and the joint venture’s
plans and ability to obtain and maintain, regulatory approval for
MVA85A; the joint venture’s plans for future
manufacture and sale of MVA85A; our plans to expand the joint venture’s
manufacturing facilities and capabilities; the rate and degree of market
acceptance and clinical utility of the joint venture’s
products; our ability to identify and acquire or in license products and
product candidates that satisfy our selection criteria; the potential
benefits of our existing collaboration agreements and our ability to
enter into additional collaboration arrangements; the timing of and our
ability to obtain and maintain regulatory approvals for our other
product candidates; our commercialization, marketing and manufacturing
capabilities and strategy; our intellectual property portfolio; our
estimates regarding expenses, future revenue, capital requirements and
needs for additional financing; and other factors identified in the
company’s current report on Form 10-Q for the
quarter ended March 31, 2008 and subsequent reports filed with the SEC.
The company disclaims 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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