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Emergent BioSolutions Initiates Phase 2 Clinical Trial for Next Generation Anthrax Vaccine NuThrax

  Emergent BioSolutions Initiates Phase 2 Clinical Trial for Next Generation
  Anthrax Vaccine NuThrax

Business Wire

ROCKVILLE, Md. -- January 17, 2013

Emergent BioSolutions Inc. (NYSE: EBS) today announced the initiation of a
Phase 2 clinical trial for NuThrax^TM (Anthrax Vaccine Adsorbed with CPG 7909
Adjuvant), also known as AV7909, with the dosing of the first subject.
NuThrax, a next generation vaccine being developed as part of Emergent's
anthrax franchise, consists of Anthrax Vaccine Adsorbed in combination with a
novel immunostimulatory adjuvant, CPG 7909.

“Emergent is pleased to initiate this Phase 2 clinical trial of NuThrax, which
supports the near-term goal and priority of the U.S. Department of Health and
Human Services (HHS) to develop next generation anthrax vaccines with advanced
characteristics such as requiring fewer doses and generating an enhanced
immune response,” said Adam Havey, EVP and president of the biodefense
division at Emergent BioSolutions. “We thank HHS for their continued trust and
partnership as we work together to accomplish elements of its Public Health
Emergency Medical Countermeasures Enterprise Implementation Plan set forth to
strengthen the nation’s biodefense capabilities.”

The Phase 2 clinical trial, a randomized, parallel-group, active-controlled,
double-blind study, is designed to evaluate the safety and immunogenicity of
NuThrax for post-exposure prophylaxis of anthrax infection using two and three
dose immunization schedules and two dose levels. The study is being conducted
in multiple sites within the U.S. and plans to enroll 168 healthy adult
volunteers. Preliminary data from this study are expected in the fourth
quarter of 2013.

Emergent has submitted to the U.S. Food and Drug Administration the Clinical
Study Report for the Phase 1 study, which evaluated the safety and
immunogenicity of NuThrax for post-exposure prophylaxis of anthrax infection
using a two dose immunization schedule and four formulations.

This Phase 2 clinical trial is being conducted with support from the National
Institute of Allergy and Infectious Diseases (NIAID), part of the National
Institutes of Health (NIH) of HHS, under development contract number
HHSN272201000035C. The Phase 1 trial was conducted with support from a
development contract jointly administered under contract number
HHSN272200800051C by NIAID and the Office of the Biomedical Advanced Research
and Development Authority (BARDA), a component of the Office of the Assistant
Secretary for Preparedness and Response (ASPR), HHS.

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.

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