Website is a central resource for published data and updates to prescribing information relating to BioThrax, such as the new 5-dose schedule and intramuscular route of administration approved by FDA in December 2008
ROCKVILLE, Md.--(BUSINESS WIRE)--May. 8, 2009--
Emergent BioSolutions Inc. (NYSE:EBS) announced today the launch of www.biothrax.com,
a website that provides information about BioThrax® (Anthrax
Vaccine Adsorbed), the only vaccine licensed by the U.S. Food and Drug
Administration (FDA) for the prevention of anthrax infection. This new
website educates visitors about key information on BioThrax, including
published data and updates to prescribing information. In December 2008,
the FDA approved the five-dose schedule and intramuscular route of
administration for BioThrax.
“Information about recent product enhancements such as the five-dose
schedule and intramuscular route of administration is made readily
available on BioThrax.com,” said Dr. James Jackson, chief scientific
officer of Emergent BioSolutions. “Emergent has developed this website
to provide information about the threat of anthrax and to help
individuals make informed decisions. BioThrax, the only FDA-licensed
anthrax vaccine, is commercially available in the United States and in
certain international markets. BioThrax.com provides a portal of
information about the risk of infection and about protection through
prevention,” he added.
BioThrax.com is designed to be a central resource for government
entities, health professionals and vaccinees, including military
personnel, emergency responders, and other individuals at high risk of
exposure to anthrax. The website also provides facts on anthrax disease
and the use of anthrax as a potential weapon of bioterrorism.
About BioThrax®
BioThrax is the only FDA-licensed vaccine for the prevention of anthrax
infection. It is indicated for the active immunization of adults who are
at high risk of exposure to anthrax. BioThrax is manufactured from a
culture filtrate, made from a non-virulent strain of Bacillus
anthracis. Since 1998, the U.S. government has procured nearly 33.5
million doses of BioThrax. During that time period, more than 8.4
million doses have been administered to more than 2.1 million military
personnel. For full FDA-approved prescribing information, please visit www.biothrax.com/prescribinginformation_biothrax_us.pdf.
Important Safety Information for BioThrax®
The most common (>10%) local (injection-site) adverse reactions observed
in clinical studies were tenderness, pain, erythema and arm motion
limitation. The most common (>5%) systemic adverse reactions were muscle
aches, fatigue and headache. Serious allergic reactions, including
anaphylactic shock, have been observed during post-marketing
surveillance in individuals receiving BioThrax.
Pregnant women should not be vaccinated unless the potential benefits of
vaccination have been determined to outweigh the potential risk to the
fetus. If BioThrax is used during pregnancy, or if the patient becomes
pregnant during the immunization series, the patient should be apprised
of the potential hazard to the fetus. This product should be
administered with caution to persons with a possible history of latex
sensitivity since the vial stopper contains dry natural rubber.
Vaccination with BioThrax should be avoided by individuals with a
history of anaphylactic or anaphylactic-like reaction following a
previous dose of BioThrax.
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a biopharmaceutical company focused on the
development, manufacture and commercialization 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 licensed by the U.S. Food and
Drug Administration for the prevention of anthrax. Emergent’s
development pipeline includes programs focused on anthrax, botulism,
tuberculosis, typhoid, hepatitis B and chlamydia. Additional information
may be found at www.emergentbiosolutions.com.
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
Vice President, Corporate
Communications
301-795-1800
SchmittT@ebsi.com
