Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has
signed an agreement to provide contract development and
manufacturing (CDMO) services for large-scale commercial drug
substance manufacturing for AstraZeneca’s COVID-19 vaccine
candidate, AZD1222. The agreement is valued at approximately $174
million through 2021 and follows an $87 million contract in June
for development services, performance and process qualification,
raw materials and an initial capacity reservation.
“Emergent is driven by our desire to advance
solutions that will make an impact on this pandemic,” said Robert
G. Kramer Sr., president and chief executive officer of Emergent
BioSolutions. “Sharing a passion for science, we are encouraged by
AstraZeneca’s investigational COVID-19 vaccine and look forward to
supporting its continued progress.”
The adenovirus vector-based vaccine candidate,
AZD1222, was co-invented by the University of Oxford and its
spin-out company, Vaccitech, and licensed by AstraZeneca. The
vaccine candidate is currently in clinical trials. It is one of the
candidates funded and supported by Operation Warp Speed (OWS), the
U.S. government’s program to accelerate the development,
manufacturing, and distribution of COVID-19 medical countermeasures
that aims to have substantial quantities of a safe and effective
vaccine available.
Syed T. Husain, senior vice president and CDMO
business unit head at Emergent, stated, “As COVID-19 vaccine
candidates progress through the pipeline, Emergent stands ready
alongside leading innovators to rapidly deploy our CDMO services to
help meet the substantial demand for a vaccine – anchored on our
foundational expertise in development and manufacturing and
propelled by our commitment to our mission – to protect and enhance
life.”
This agreement follows and is in addition to the
landmark public-private CDMO partnership between Emergent and the
Biomedical Advanced Research and Development Authority (BARDA)
announced in June to pave the way for OWS high-priority
innovators.
Activities under this agreement will be performed
at Emergent’s Baltimore Bayview facility, where certain
manufacturing capacity reserved by BARDA through the CDMO task
order issued to Emergent under OWS will be used. Emergent’s
Baltimore Bayview facility is a designated Center for Innovation in
Advanced Development and Manufacturing (CIADM) by the U.S.
Department of Health and Human Services (HHS) designed for rapid
manufacturing of large quantities of vaccines and treatments during
public health emergencies.
The CIADM has unique capabilities across four
independent suites to produce at clinical scale to get candidates
rapidly into the clinic, while at the same time scaling up to
enable large-scale manufacturing to up to 4000L to prepare for
production of commercial volumes to meet customer demand. The CIADM
has the capacity to produce tens to hundreds of millions of doses
of vaccine on an annual basis, based upon the platform technology
being used.
Financial ConsiderationsThe
company will provide an update to its 2020 financial outlook
incorporating expectations related to this agreement and any other
relevant information when it reports its second quarter financial
results on July 30, 2020.
About Emergent
BioSolutionsEmergent BioSolutions is a global life
sciences company whose mission is to protect and enhance life.
Through our specialty products and contract development and
manufacturing services, we are dedicated to providing solutions
that address public health threats. Through social responsibility,
we aim to build healthier and safer communities. We aspire to
deliver peace of mind to our patients and customers so they can
focus on what’s most important in their lives. In working together,
we envision protecting or enhancing 1 billion lives by 2030. For
more information visit www.emergentbiosolutions.com. Find us on
LinkedIn and follow us on Twitter @emergentbiosolu and Instagram
@life_at_emergent.
Emergent’s Response to
COVID-19Emergent BioSolutions is deploying its decades of
experience in vaccine and hyperimmune development and
manufacturing, as well as its molecule-to-market contract
development and manufacturing (CDMO) services to provide
comprehensive medical countermeasure solutions in response to the
COVID-19 pandemic.
Using its established hyperimmune platforms,
Emergent is developing two investigational plasma-based treatments
- COVID-Human Immune Globulin (COVID-HIG) and COVID-Equine Immune
Globulin (COVID-EIG). COVID-HIG is being developed as a human
plasma-derived therapy candidate with $14.5 million in HHS funding
and will be evaluated in two studies of the National Institute of
Allergy and Infectious Diseases, part of the National Institutes of
Health, for potential treatment of COVID-19 in severe hospitalized
and high-risk patients. With $34.6 million in funding from the
Department of Defense and in collaboration with the Mount Sinai
Health System and ImmunoTek Bio Centers, COVID-HIG will also be
evaluated for post-exposure prophylaxis in populations at high risk
of COVID-19, such as front-line health care workers and the
military. COVID-EIG is being developed as an equine plasma-derived
therapy candidate for potential treatment of severe disease in
humans. Both candidates are anticipated to be in Phase 2 clinical
studies in 2020. These investigational products are not approved by
the U.S. Food and Drug Administration and their safety and
effectiveness have not been established.
Emergent is deploying its CDMO capabilities,
capacities, and expertise to support the U.S. government’s
Operation Warp Speed to pave the way for innovators to advance
COVID-19 programs. The company is working with four innovators to
develop and manufacture COVID-19 vaccine candidates. For the
COVID-19 vaccine response, Emergent’s integrated CDMO network
provides development services from its Gaithersburg facility, drug
substance manufacturing at its Baltimore Bayview facility, and drug
product manufacturing at its Baltimore Camden and Rockville
facilities, all in Maryland.
For 22 years Emergent has focused on advancing
public health, and its multi-pronged approach to tackling COVID-19
demonstrates its commitment to its mission – to protect and enhance
life.
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 our ability to produce viable COVID-19 vaccine
candidates at the prescribed scale and on the anticipated timeline
and pave their potential pathway to licensure, the total value and
anticipated duration of activities under the announced AstraZeneca
contract as well as the negotiation of any further commitments or
contracts related to the collaboration and deployment of capacity
toward future commercial manufacturing, 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 the success
of the planned development programs; the timing of and ability to
obtain and maintain regulatory approvals for the product
candidates; and our commercialization, marketing and manufacturing
capabilities. 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.
Media Contact:Miko B. NeriSenior
Director, Global Communications & Public
Affairs240-631-3392NeriM@ebsi.com
Investor Contact:Robert G.
BurrowsVice President, Investor
Relations240-631-3280BurrowsR@ebsi.com
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