Emergent BioSolutions Completes Acquisition of ACAM2000® Business From Sanofi
October 06 2017 - 11:01AM
Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has
completed its acquisition of Sanofi’s ACAM2000®, (Smallpox
(Vaccinia) Vaccine, Live) business, which includes ACAM2000, the
only smallpox vaccine approved by the U.S. Food and Drug
Administration (FDA), a cGMP live viral manufacturing facility and
office and warehouse space, both in Canton, Massachusetts, and a
cGMP viral fill/finish facility in Rockville, Maryland. With this
acquisition, Emergent also plans to assume responsibility for an
existing 10-year contract with the Centers for Disease Control and
Prevention (CDC), originally valued at up to $425 million and with
a remaining value of up to approximately $160 million, for the
delivery of ACAM2000 to the Strategic National Stockpile (SNS) and
establishing U.S.-based manufacturing of ACAM2000. The completion
of the acquisition follows the satisfaction or waiver by the
parties, as applicable, of all closing conditions, including
termination of the waiting period under the Hart-Scott-Rodino
Antitrust Improvements Act of 1976 (HSR Act), as amended.
“Emergent is pleased with the closing of this transaction, which
expands our portfolio of revenue-generating products, strengthens
our manufacturing capabilities, and grows our workforce of talented
and committed professionals,” said Daniel J. Abdun-Nabi, president
and chief executive officer of Emergent BioSolutions. “We look
forward to integrating the ACAM2000 business into our operations
and working with the U.S. government to ensure an uninterrupted
supply of ACAM2000 to the SNS.”
At the closing, Emergent paid $97.5 million in an upfront
payment and $20 million in milestone payments earned as of the
closing date tied to the achievement of certain regulatory and
manufacturing-related milestones, for a total payment in cash of
$117.5 million. The agreement includes a potential milestone
payment of up to $7.5 million, tied to the achievement of the
remaining regulatory milestone event.
Facility Licensure and Resumption of ACAM2000
DeliveriesWith the closing of the transaction, Emergent
expects to complete the tech transfer of an upstream portion of
ACAM2000 manufacturing to the Canton facility. Fulfillment of all
remaining product deliveries under the existing CDC contract is
contingent on Emergent successfully securing FDA approval of a
recent supplemental Biologics License Application (sBLA)
submission.
The company anticipates resuming deliveries of ACAM2000 under
the existing CDC contract in 2018. In addition, the CDC contract
will expire and be up for renewal or extension in 2018 and the
company intends to negotiate a follow-on, multi-year contract with
the U.S. government to ensure the continued supply of ACAM2000 to
the SNS.
2017 Financial ForecastThe company will be
issuing financial results in early November for the three and nine
months ended September 30, at which time it will provide an update
on the impact of this transaction on full-year 2017 guidance.
About ACAM2000ACAM2000 is the primary smallpox
vaccine designated for use in a bioterrorism emergency, with
more than 230 million doses having been supplied to the U.S.
Strategic National Stockpile. ACAM2000 is also licensed in
Australia and Singapore, and is currently stockpiled both in the
U.S. and internationally.
About SmallpoxSmallpox is a highly contagious
disease caused by the variola virus, a member of the Orthopox virus
family. According to the CDC, it is one of the most
devastating diseases with a mortality rate as high as 30%. Smallpox
is classified by the CDC as a Category A bioterrorism agent and the
U.S. government continues to invest in countermeasures to protect
the nation from this threat. Governments around the world are also
taking precautionary measures to be ready to deal with a potential
smallpox outbreak.
About Emergent BioSolutionsEmergent
BioSolutions Inc. is a global life sciences company seeking to
protect and enhance life by focusing on providing specialty
products for civilian and military populations that address
accidental, intentional, and naturally emerging public health
threats. Through our work, we envision protecting and enhancing 50
million lives with our products by 2025. Additional information
about the company may be found at www.emergentbiosolutions.com.
Follow us @emergentbiosolu.
Safe Harbor StatementThis 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 the expected FDA licensure of the U.S. manufacturing
facility for ACAM2000, the anticipated delivery schedule under the
existing CDC contract, the potential opportunities and financial
impact of the transaction, and any other statements containing the
words “believes,” “expects,” “anticipates,” “intends,” “plans,”
“targets,” “forecasts,” “estimates” and similar expressions are
forward-looking statements. These forward-looking statements are
based on our current intentions, beliefs and expectations regarding
future events. We cannot guarantee that any forward-looking
statement will be accurate. Investors should realize that if
underlying assumptions prove inaccurate or unknown risks or
uncertainties materialize, actual results could differ materially
from our expectations. Investors are, therefore, cautioned not to
place undue reliance on any forward-looking statement. Any
forward-looking statement speaks only as of the date of this press
release, and, except as required by law, we do not undertake to
update any forward-looking statement to reflect new information,
events or circumstances.
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 our ability to
successfully integrate the business and realize the benefits of the
transaction; the timing of expected FDA approval of the sBLA; our
ability to extend or to otherwise deliver under the ACAM2000
contract with the CDC upon its expiration in 2018; the timing and
yearly volume of product deliveries to the CDC once such deliveries
have resumed under the current contract; the availability of
funding and the exercise of options under the current contract for
ACAM2000; and our ability to secure a follow-on, multi-year
contract with the CDC.
The foregoing sets forth many, but not all, of the factors that
could cause actual results to differ from our expectations in any
forward-looking statement. Investors should consider this
cautionary statement, as well as the risk factors identified in our
periodic reports filed with the SEC, when evaluating our
forward-looking statements.
Investor Contact:Robert G.
BurrowsVice President, Investor
Relations240-631-3280BurrowsR@ebsi.com
Media Contact:Lynn KiefferVice
President, Corporate Communications
240-631-3391KiefferL@ebsi.com
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