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-- Wellcome Trust and Aeras Global TB Vaccine Foundation have
agreed to provide GBP 8 million in funding for Phase IIb clinical
trial that is expected to commence in 2009
-- The vaccine candidate, MVA85A, has been granted orphan drug
designation by the European Medicines Agency (EMEA)
-- If successful, MVA85A would be the first new vaccine licensed
to prevent tuberculosis in over 80 years
OXFORD, England & ROCKVILLE, Md.--(BUSINESS WIRE)--July 23,
2008--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 GBP 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(R) (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 GBP 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.
MULTIMEDIA AVAILABLE:
http://www.businesswire.com/cgi-bin/mmg.cgi?eid=5737819
CONTACT: Emergent BioSolutions Inc.
Investors Contact:
Robert G. Burrows
Vice President, Investor Relations
301-795-1877
BurrowsR@ebsi.com
or
Media Contact:
Tracey Schmitt
Director, Corporate Communications
301-795-1800
SchmittT@ebsi.com
or
University of Oxford
Media Contact:
Jonathan Wood
Press Officer, Medical Sciences
+44 (0) 1865 280530
press.office@admin.ox.ac.uk
or
Aeras Global TB Vaccine Foundation
Media Contact:
Annmarie Leadman
Director of Communications
240-599-3018
SOURCE: Emergent BioSolutions Inc.
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