|
ROCKVILLE, Md.--(BUSINESS WIRE)--Sept. 3, 2008--Emergent
BioSolutions Inc. (NYSE:EBS) announced today that it has received a
contract from the Department of Health and Human Services (HHS) for
over $24.3 million to fund the further development of Emergent's
anthrax monoclonal antibody AVP-21D9. This contract will be jointly
administered through the Office of the Biomedical Advanced Research
and Development Authority (BARDA), and the National Institute of
Allergy and Infectious Diseases (NIAID), a component of the National
Institutes of Health (NIH). The four year contract provides funding
for scale-up of the manufacturing process, for non-clinical studies,
and for a Phase I clinical trial. Emergent anticipates that it will
receive approximately $20 million over the first two contract years in
support of the scale-up of the manufacturing process and the
completion of a Phase I clinical trial. Emergent expects to focus on
completing certain non-clinical studies during the final two years of
the contract.
"We are very pleased to have secured this important contract with
HHS. The AVP-21D9 antibody is a fully human antibody that has
demonstrated very high affinity to the anthrax toxin in animal studies
and shows great promise as an effective post-exposure anthrax
therapeutic. We believe this funding from HHS underscores the U.S.
government's commitment to a multi-prong approach in responding to the
threat of bioterrorism in our country. We are certainly encouraged
that we were able to secure this contract so soon following our
acquisition of AVP-21D9 earlier this year," said Stephen Lockhart,
senior vice president, product development of Emergent BioSolutions.
The continued development of this anthrax monoclonal antibody
candidate further solidifies Emergent's franchise of anthrax
countermeasures, which now includes:
BioThrax(R) - the only FDA-approved vaccine to prevent anthrax.
More than two million men and women of the United States military have
received the vaccine, and HHS has procured more than 28 million doses
of BioThrax for the SNS;
rPA - a recombinant anthrax vaccine candidate, which is composed
of a purified protein with an aluminum adjuvant and is designed to
induce antibodies that neutralize anthrax toxins;
AV7909 - an anthrax vaccine candidate composed of BioThrax(R) and
the immunostimulatory oligodeoxynucleotide compound CPG 7909
(VaxImmune(R)), licensed from Pfizer Inc;
AIG - a polyclonal anthrax immunoglobulin product candidate being
developed as an intravenous post-exposure treatment for patients who
present with symptoms of anthrax disease, AIG is derived from human
plasma from individuals who have been vaccinated with BioThrax.
This project has been funded in whole or in part with Federal
funds from the Biomedical Advanced Research and Development Authority
(BARDA), Department of Health and Human Services, and the National
Institute of Allergy and Infectious Diseases, National Institutes of
Health, Department of Health and Human Services, under Contract No.
HHSN272200800040C and from the National Institute of Allergy and
Infectious Diseases, National Institutes of Health, Department of
Health and Human Services, under Grant No. U01AI070493-01.
About the AVP-21D9 anthrax monoclonal antibody candidate
AVP-21D9 is a fully human anthrax monoclonal antibody that appears
to be a highly active therapeutic for anthrax based on laboratory and
animal studies conducted to date. This could be due to its putative
mechanism of action compared to other monoclonal candidates under
development - binding to protective antigen and inhibiting heptamer
(pore) formation, rather than inhibiting binding of toxin to its
receptor. Based on non-clinical studies in mice, rats, and rabbits,
AVP-21D9 provides a high level of protection even in animals with
clinical symptoms of anthrax. These studies indicate that AVP-21D9 has
the potential to be a life-saving medical countermeasure and to fill
an important unmet need. AVP-21D9 was acquired from Avanir
Pharmaceuticals (Nasdaq:AVNR) in March 2008, which advanced the
technology through proof-of-concept studies and clinical-scale
manufacturing funded by a NIAID grant.
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a leading biopharmaceutical company
dedicated to one simple mission--to protect life. Emergent develops,
manufactures and commercializes immune related biologics, vaccines and
biotherapeutics that assist the body's immune system to prevent or
treat infectious and other life threatening diseases. Emergent's
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. Emergent's clinical pipeline includes
programs targeting anthrax, botulism, typhoid, tuberculosis and
hepatitis B. www.emergentbiosolutions.com.
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 timing of, and the potential for successful
outcomes resulting from future product development efforts and our
ability to obtain additional funding from the U.S. government for
them, and other factors identified in the company's current report on
Form 10-Q for the quarter ended June 30, 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.
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
SOURCE: Emergent BioSolutions Inc.
|