Biological E. of Hyderabad, India to Serve as Marketing Agent for BioThrax in India
ROCKVILLE, Md.--(BUSINESS WIRE)--Feb. 12, 2009--
Emergent BioSolutions Inc. (NYSE:EBS) announced today that the Drugs
Controller General of India (DCGI) has issued a registration certificate
for BioThrax® (Anthrax Vaccine Adsorbed), which enables the
marketing and sale of the vaccine in India to help prevent anthrax
infection. Emergent BioSolutions has signed a marketing agreement with
Biological E. Limited for the marketing of BioThrax in India. BioThrax
is the only vaccine for the prevention of anthrax infection licensed by
the U.S. Food and Drug Administration (FDA).
The BioThrax market authorization for India follows the publication in
2008 of the National Disaster Management Guidelines by the Indian
National Disaster Management Authority (NDMA), which is the government
body that oversees disaster management. In that document, the government
of India provided guidance with respect to the management of biological
disasters and stated that there is a need to have a supply of readily
available anthrax vaccines to be administered rapidly in the event of an
outbreak. The report goes on to state that all first responders will be
vaccinated in an impending disaster situation.
Fuad El-Hibri, chairman and chief executive officer of Emergent
BioSolutions, stated, “The Government of India has been explicit in
expressing its commitment to protect its population from the continuing
threat of bioterrorism. We are certainly pleased that BioThrax will be a
valuable countermeasure available to the Government of India to achieve
that goal. Today marks a pivotal milestone in Emergent’s efforts to
expand globally and further our mission of protecting life.”
About BioThrax® (Anthrax Vaccine Adsorbed)
BioThrax is the only FDA-licensed vaccine for the prevention of anthrax
infection. It is licensed 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 Bacillus anthracis and contains no dead or
live bacteria. Since 1998, the U.S. government has procured nearly 33.5
million doses of BioThrax. During that time period, nearly 8.4 million
doses have been administered to more than 2.1 million military
personnel. BioThrax cannot cause anthrax infection. Please visit www.emergentbiosolutions.com/pdf/emergent_biothrax_us.pdf
for full prescribing information.
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a biopharmaceutical company focused on the
development, manufacture and commercialization of immune-related
biologic products, consisting of vaccines and therapeutics that assist
the body’s immune system to prevent or treat disease. Emergent’s
marketed product, BioThrax® (Anthrax Vaccine Adsorbed), is
the only vaccine approved by the U.S. Food and Drug Administration for
the prevention of anthrax infection. Emergent’s development pipeline
includes programs focused on anthrax, botulism, typhoid, tuberculosis,
hepatitis B and chlamydia. Additional information may be found 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 any potential future securities
offering, 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
appropriations for BioThrax procurement; our ability to obtain new
BioThrax sales contracts; our plans to pursue label expansions and
improvements for BioThrax; our plans to expand our manufacturing
facilities and capabilities; the rate and degree of market acceptance
and clinical utility of our products; the timing of and our ability to
obtain and maintain regulatory approvals for our other product
candidates; our commercialization, marketing and manufacturing
capabilities and strategy; 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, 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.
Source: Emergent BioSolutions Inc.
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
