Product Development
Our goal is to become a worldwide leader in developing, manufacturing and commercializing
immunobiotics that target diseases with significant unmet or underserved medical
needs. Two key components of our business strategy are to continue to develop a
balanced portfolio of immunobiotic products and to focus on core capabilities in
product development and manufacturing.
We seek to maintain a balanced product portfolio that includes both biodefense and
commercial immunobiotic product candidates and both vaccines and therapeutics to
diversify product development and commercialization risk. We use multiple technologies
in our development programs, which we believe significantly reduces our risk in
these activities. We expect that biodefense product candidates may generate revenues
from product sales sooner than commercial product candidates because of Project
BioShield, which allows the U.S. government to purchase biodefense products for
the strategic national stockpile before they are approved by the FDA.
We focus our efforts on immunobiotic product development and manufacturing, which
we believe are our core capabilities. This approach enables us to avoid the expense
and time entailed in early stage research activities and, we believe, reduces product
development and commercialization risk. We seek to obtain marketed products and
development stage product candidates through acquisitions and licensing arrangements
with third parties. We believe that we have secured, and will be able to continue
to secure, rights to a diverse product pipeline that targets diseases with significant
unmet or underserved medical needs. We also believe that this approach may enable
us to accelerate product development timelines through our preclinical and clinical
development and regulatory expertise and manufacturing capabilities.
Our biodefense product portfolio includes three biodefense product candidates in
preclinical development and a next generation anthrax vaccine program with product
candidates in preclinical and Phase I clinical development. We are developing all
of our biodefense product candidates to address category A biological agents, which
are the class of biological agents that the CDC has identified as the greatest possible
threat to public health. Our biodefense product candidates are anthrax immune globulin,
botulinum immune globulin, recombinant bivalent botulinum vaccine, and a next generation
anthrax vaccine.
Our commercial product portfolio includes two product candidates in Phase II clinical
development, one vaccine candidate in Phase I clinical development and two vaccine
candidates in preclinical development. Our commercial product candidates in clinical
development include an oral typhoid vaccine, an oral Hepatitis B therapeutic vaccine,
a Group B streptococcus vaccine, a meningitis B vaccine and a chlamydia vaccine.
We have product development facilities in Gaithersburg, Maryland, and Reading, UK.
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