Emergent BioSolutions Initiates Phase 2 Study in Pursuit of a Post-Exposure Prophylaxis Indication for BioThrax

  Emergent BioSolutions Initiates Phase 2 Study in Pursuit of a Post-Exposure
  Prophylaxis Indication for BioThrax

Business Wire

ROCKVILLE, Md. -- January 22, 2013

Emergent BioSolutions Inc. (NYSE: EBS) today announced the initiation of a
Phase 2 study designed to evaluate non-interference of BioThrax^® (Anthrax
Vaccine Adsorbed) when administered in conjunction with antibiotics. This
non-interference study will be used to support a supplemental Biologics
License Application seeking licensure of a Post-Exposure Prophylaxis (PEP)
indication for BioThrax to be used in combination with antibiotics in people
suspected to have been exposed to anthrax spores. Currently, BioThrax is
licensed for a pre-exposure prophylaxis indication only.

“Emergent continues to advance its BioThrax Post-Exposure Prophylaxis program
to enhance the clinical utility of BioThrax, the only vaccine licensed by the
U.S. Food and Drug Administration for the active immunization against anthrax
disease,” said Adam Havey, EVP and president of the biodefense division at
Emergent BioSolutions. “Inhalation anthrax is highly lethal when left
untreated. Through our partnership with the Biomedical Advanced Research and
Development Authority (BARDA), we are exploring how our vaccine can fit in the
current PEP treatment regimen, which consists of only oral antibiotics. We
remain committed to working in partnership with BARDA to advance critical
countermeasures that help ensure the nation’s preparedness.”

The primary objective of this Phase 2, randomized, open label study is to
evaluate any impact of the vaccine on ciprofloxacin by administering the
antibiotic prior to and following the administration of a 3-dose series of
BioThrax. The study, which will enroll 120 healthy adult volunteers and is
being conducted in multiple sites within the U.S., will also provide
additional safety data on the concurrent administration of ciprofloxacin and
BioThrax. Preliminary data from this study are expected in the fourth quarter
of 2013.

This study is fully funded under contract number HHSO100200700037C provided by
BARDA within the Office of the Assistant Secretary for Preparedness and
Response in the U.S. Department of Health and Human Services.

About Emergent BioSolutions

Emergent BioSolutions is a specialty pharmaceutical company seeking to protect
and enhance life by offering specialized products to healthcare providers and
governments to address medical needs and emerging health threats. Additional
information may be found at www.emergentbiosolutions.com. Follow us on
twitter: @emergentbiosolu.

About BioThrax

BioThrax is the only FDA-licensed vaccine for the prevention of anthrax
disease. It is indicated for the active immunization of adults who are at high
risk of exposure to anthrax. The safety and efficacy of BioThrax in a
post-exposure setting have not been established. Individuals are not
considered protected until they have completed the three-dose primary
immunization series. Vaccination with BioThrax may not protect all
individuals.

BioThrax is manufactured from a culture filtrate, made from a non-virulent
strain of Bacillus anthracis. To date, Emergent has delivered over 66 million
doses of BioThrax to the U.S. government and continues to deliver additional
doses under active procurement contracts. Since 1998, over 11 million doses
have been administered to more than 2.9 million military personnel. For full
prescribing information, please visit
http://www.biothrax.com/prescribinginformation_biothrax_us.pdf.

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, prospects, plans and objectives of management,
and any other statements containing the words “believes”, “expects”,
“anticipates”, “intends”, “plans”, “estimates” and similar expressions, are
forward-looking statements. These forward-looking statements are based on our
current intentions, beliefs and expectations regarding future events. We
cannot guarantee that any forward-looking statement will be accurate.
Investors should realize that if underlying assumptions prove inaccurate or
unknown risks or uncertainties materialize, actual results could differ
materially from our expectations. Investors are, therefore, cautioned not to
place undue reliance on any forward-looking statement. Any forward-looking
statement speaks only as of the date of this press release, and, except as
required by law, we do not undertake to update any forward-looking statement
to reflect new information, events or circumstances.

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 success of our ongoing and planned preclinical
studies and clinical trials; the rate and degree of market acceptance and
clinical utility of our products; the success of our ongoing and planned
development programs; the timing of and our ability to obtain and maintain
regulatory approvals for our product candidates; our commercialization,
marketing and manufacturing capabilities and strategy; and our estimates
regarding expenses, future revenue, capital requirements and needs for
additional financing. The foregoing sets forth many, but not all, of the
factors that could cause actual results to differ from our expectations in any
forward-looking statement. Investors should consider this cautionary
statement, as well as the risk factors identified in our periodic reports
filed with the SEC, when evaluating our forward-looking statements.

Contact:

Emergent BioSolutions
Investors:
Robert G. Burrows
Vice President, Investor Relations
301-795-1877
BurrowsR@ebsi.com
or
Media:
Tracey Schmitt
Vice President, Corporate Communications
301-795-1800
SchmittT@ebsi.com
 
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