$9.5 Million Development Contract to Fund Non-Clinical and
Clinical Studies of Anthrax Immune Globulin (AIG) over Next 24 Months
ROCKVILLE, Md.--(BUSINESS WIRE)--Sept. 27, 2007--Emergent
BioSolutions Inc. (NYSE:EBS) announced today that it has received a
development contract, valued at up to $9.5 million, in support of
non-clinical and clinical studies of the company's anthrax
therapeutic, or AIG, product candidate. This product candidate is an
immune globulin being developed as an intravenous therapeutic for
treatment of patients who present with symptoms of anthrax disease
following exposure to anthrax.
This development contract has been funded in whole or in part from
Federal funds from the National Institute of Allergy and Infectious
Diseases (NIAID), National Institutes of Health (NIH) and the
Biomedical Advanced Research and Development Authority (BARDA),
Department of Health and Human Services (HHS), under Contract No.
HHSN272200700034C.
Fuad El-Hibri, chairman and chief executive officer of Emergent
BioSolutions, stated, "We are very pleased to have continuing support
for AIG from NIAID and BARDA and commend the leadership throughout HHS
for their commitment to funding the development of effective medical
countermeasures against this deadly biological agent. With the
continued development funding of our AIG candidate, in conjunction
with the $448 million contract with HHS announced yesterday regarding
procurement of 18.75 million doses of our BioThrax anthrax vaccine for
the strategic national stockpile, we are very encouraged by the
government's support of our anthrax franchise. We look forward to
continuing to be a leading participant in the U.S. government's effort
to build a robust domestic biodefense industry."
Under terms of the development award, the funds will be used to
conduct various studies on AIG, including (i) non-clinical studies in
support of efficacy; and (ii) a Phase I/II clinical study to evaluate
pharmacokinetics and safety. Previously, in August 2006 the company
received $3.9 million from NIAID in support of the company's AIG
program. When combined with the $9.5 million under this new
development award, the total amount of government funding for AIG to
date is over $13 million.
About Anthrax Immune Globulin (AIG)
Emergent BioSolutions' anthrax immune globulin (AIG) is being
developed as an intravenous therapeutic for treatment of patients who
present with symptoms of anthrax disease resulting from the release of
anthrax toxins into the body and for whom the use of the vaccine is no
longer an effective option. If successfully developed, AIG could be
prescribed for administration in these circumstances either as a
monotherapy or in conjunction with an antibiotic.
AIG is being developed using plasma collected from healthy donors
who have been vaccinated with BioThrax(R) (Anthrax Vaccine Adsorbed),
Emergent BioSolutions' anthrax vaccine, which is the only vaccine
approved by the U.S. Food and Drug Administration for the prevention
of anthrax infection.
The company has collected a sufficient amount of plasma to
initiate manufacturing of AIG under cGMP using a validated and
approved process. This manufacturing process entails fractionating the
plasma and purifying the immune globulin. The company has signed an
exclusive license with Talecris Biotherapeutics, Inc., a North
Carolina-based biopharmaceutical company and leading fractionation
provider, to fractionate, purify and fill AIG at Talecris'
FDA-approved facilities. To date, the first full-scale lot of AIG has
been manufactured under cGMP requirements at Talecris. The company has
scheduled plans to complete a second full-scale lot of AIG.
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a biopharmaceutical company
dedicated to one simple mission--to protect life. We develop,
manufacture and commercialize immunobiotics, consisting of vaccines
and therapeutics that assist the body's immune system to prevent or
treat disease. Our biodefense business focuses on immunobiotics for
use against biological agents that are potential weapons of
bioterrorism and biowarfare. 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.
Our commercial business focuses on immunobiotics for use against
infectious diseases and other medical conditions that have resulted in
significant unmet or underserved public health needs. More information
on the company is available at 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 performance under our contract
with HHS and future payments from HHS to us under the contract, 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 our
plans to expand our manufacturing facilities and capabilities; the
rate and degree of market acceptance and clinical utility of our
products; our ongoing and planned development programs, preclinical
studies and clinical trials; 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 selective additional
collaboration arrangements; the timing of and our ability to obtain
and maintain regulatory approvals for our 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
Quarterly Report on Form 10-Q for the quarter ended June 30, 2007 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.
Investor 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.