ROCKVILLE, Md.--(BUSINESS WIRE)--Mar. 22, 2012--
Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has
received a multi-year grant from the National Institute of Allergy and
Infectious Diseases (NIAID), part of the National Institutes of Health,
to advance the development of MVA85A, a candidate vaccine against
tuberculosis (TB). The vaccine is being developed through a partnership
between Aeras and the Oxford-Emergent Tuberculosis Consortium (OETC), a
joint venture between Emergent and the University of Oxford, where the
vaccine was originally developed and investigated.
MVA85A is now completing a Phase 2b clinical trial sponsored by Aeras to
evaluate the safety and efficacy of the vaccine in over 2,700 infants in
South Africa. Results from this trial, which has received continued
funding from Aeras and the Wellcome Trust, are anticipated later this
year. MVA85A is also currently being studied in a second Phase 2b
clinical trial, with primary funding and support from the European and
Developing Countries Clinical Trials Partnership and Aeras, which will
enroll approximately 1,400 adults living with the human immunodeficiency
virus (HIV) in Senegal and South Africa.
“Emergent is honored to gain NIAID support, expanding the current
government and non-government partners that are joining forces to
advance this vaccine candidate. We all share a vision to declare victory
in the global fight against tuberculosis and Emergent is proud to be at
the forefront with such distinguished organizations,” said Daniel J.
Abdun-Nabi, President and Chief Operating Officer of Emergent
BioSolutions. “With efficacy data expected in the coming months, we are
hopeful that MVA85A will have a significant impact on the global burden
of this highly contagious and lethal disease.”
According to the World Health Organization, approximately 1.5 million
people die from tuberculosis annually, and more than two billion people
are infected with TB – an estimated one out of every three people on the
planet. It is the second leading cause of death from infectious disease
worldwide. The limited efficacy against pulmonary TB of the only
available licensed TB vaccine, Bacille Calmette-Guerin (BCG), and the
rise of multi-drug and extensively-drug resistant TB cases, demonstrate
the need for improved control measures against TB.
“We join the rest of the world in observing World TB Day on March 24,
commemorating the discovery of the cause of the disease, the TB
bacillus, that paved the way for the development of TB treatments,
diagnostics, and vaccines,” said Dr. Jacqui Shea, General Manager of
OETC. “Through much appreciated and essential grant funding, product
development partnerships are making significant steps forward to stop
TB. With continued support and collaboration, we hope to achieve our
shared goal of a world free of TB within our lifetime.”
About Emergent BioSolutions Inc.
Emergent BioSolutions protects and enhances life by developing and
manufacturing vaccines and therapeutics that are supplied to healthcare
providers and purchasers for use in preventing and treating disease.
Emergent's marketed and investigational products target infectious
diseases, oncology and autoimmune disorders. Additional information
about the company may be found at www.emergentbiosolutions.com.
The MVA85A vaccine candidate is intended to boost the response of
T-cells already stimulated by the BCG vaccine. The vaccine candidate was
originally developed at the University of Oxford by Professor Helen
McShane, a professor of vaccinology and Wellcome Trust Senior Fellow,
working with Dr. Sarah Gilbert, a Reader in Vaccinology, and Professor
Adrian Hill, a Wellcome Trust Principal Research Fellow. It was licensed
to the Oxford-Emergent Tuberculosis Consortium by Isis Innovation, the
University’s technology transfer company, in July 2008. Previous
clinical trials of the vaccine in adults – supported by the Wellcome
Trust – in the United Kingdom, the Gambia, Senegal and South Africa have
demonstrated consistently high cellular immune responses in those who
received the MVA85A vaccine candidate following vaccination with BCG. To
date, the vaccine has been shown to have an acceptable safety profile.
The vaccine has been awarded orphan drug status by the European
Medicines Agency (EMA) and is the most clinically advanced of a new
generation of tuberculosis vaccine candidates.
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, 2011 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.
Source: Emergent BioSolutions Inc.
Emergent BioSolutions Inc.
Vice President, Investor Relations
Vice President, Corporate