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Emergent entitled to approximately $30 million from HHS for prior
deliveries to the Strategic National Stockpile; amount expected to be
recognized as revenue in 2Q 2009
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FDA approval triggers BioThrax price increase for future deliveries
under HHS procurement contracts
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HHS follow-on procurement contract for the delivery of 14.5 million
doses now based on an increased price per dose and valued at $405
million
Emergent BioSolutions Inc. (NYSE:EBS) announced today that its flagship
product, BioThrax® (Anthrax Vaccine Adsorbed), has been
granted a shelf life extension from 3 to 4 years by the U.S. Food and
Drug Administration (FDA). Based on this approval, Emergent has achieved
a contract milestone warranting a payment of approximately $30 million
for doses previously delivered to the Strategic National Stockpile (SNS)
under the terms of the company’s existing BioThrax procurement contracts
with the Department of Health and Human Services (HHS). This amount is
expected to be recognized as revenue in the second quarter of 2009. In
addition, FDA approval of 4-year expiry dating results in an immediate
price increase for the future delivery of BioThrax doses under the
current contract as well as under the follow-on multi-year contract,
valued at $405 million, for the delivery of 14.5 million doses of
BioThrax.
“We are pleased that the FDA has approved the 4-year expiry dating of
BioThrax as this extends the ability of the U.S. government to store our
product in the nation’s Strategic National Stockpile,” said Fuad
El-Hibri, chairman and chief executive officer of Emergent BioSolutions.
“This is a critically important product feature that we believe will
increase the attractiveness of BioThrax to the U.S. government as it
increases BioThrax’s lifecycle value. We are continuing our efforts to
further enhance the attributes of BioThrax, including research towards a
further reduction in the vaccination schedule and an expanded label
indication for post-exposure prophylaxis. We believe these enhancements,
if approved, will advance the U.S. government’s preparedness efforts in
response to anthrax as a potential weapon of bioterrorism.”
Emergent has been pursuing a number of BioThrax product enhancements
over the past several years. In addition to FDA approval of 4-year
dating for BioThrax, in December 2008, Emergent received FDA approval of
a reduced vaccination regimen to a five-dose schedule and a change to an
intramuscular route of administration.
