Milestone triggers $8.8 million payment from Department of Health
and Human Services under recently announced $448 million contract
ROCKVILLE, Md.--(BUSINESS WIRE)--Nov. 5, 2007--Emergent
BioSolutions Inc. (NYSE:EBS) announced today that it has completed a
human clinical study that will be used to support expanding the
indication for BioThrax(R) (Anthrax Vaccine Adsorbed) to include
post-exposure prophylaxis (PEP) for the treatment of individuals
exposed to anthrax. The company has also submitted a final study
report for this clinical trial to the Department of Health and Human
Services (HHS) which triggers a payment of $8.8 million from HHS under
the terms of the $448 million dollar contract announced on September
26th of this year. This clinical trial focused on the immunogenicity
of a three-dose BioThrax regimen when used for post-exposure
prophylaxis in adults.
"We are very pleased to have reached this contract milestone in
our pursuit of achieving a PEP indication for BioThrax. We recognize
how significant the development of a post-exposure prophylaxis
indication is to fulfilling our mission to protect life. HHS shares
our commitment to this important project and we are grateful for their
support as we continue to make progress on this critical program,"
said Fuad El-Hibri, chairman and chief executive officer of Emergent
The primary objective of the clinical trial was to determine the
timing and peak of the immune response following three doses of
BioThrax for PEP. This study, together with non-clinical and clinical
studies planned during 2008, is intended to support a proposed
application to the U.S. Food and Drug Administration to expand the
approved indication for BioThrax to include PEP.
About BioThrax(R) (Anthrax Vaccine Adsorbed)
BioThrax is the only FDA-approved vaccine for the prevention of
anthrax infection. It is approved by the FDA as a pre-exposure
prophylaxis for use in adults who are at high risk of exposure to
anthrax spores. BioThrax is manufactured from a culture filtrate, made
from a non-virulent strain of Baccillus anthracis and contains no dead
or live bacteria. BioThrax is administered by subcutaneous injection
in three initial doses followed by three additional doses, with an
annual booster dose recommended thereafter. Since 1998, approximately
20 million doses of BioThrax have been procured by the U.S.
government. During that time period, over 6.5 million doses have been
administered to over 1.6 million military personnel. BioThrax cannot
cause anthrax infection.
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 disease.
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, prospects, plans
and objectives of management, including clinical trial results and
development plans, 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 rate and degree of market acceptance and
clinical utility of our products; our ongoing and planned development
programs, preclinical studies and clinical trials, including future
clinical data for our typhoid vaccine candidate; 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
September 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.
Robert G. Burrows
Vice President, Investor Relations
Director, Corporate Communications
SOURCE: Emergent BioSolutions Inc.