Emergent BioSolutions Inc. (NYSE:EBS) today announced it will
deploy its molecule-to-market contract development and
manufacturing (CDMO) services to support the manufacturing of
AstraZeneca’s vaccine candidate for COVID-19, AZD1222, a viral
vector-based, weakened version of adenovirus containing the genetic
material of SARS-CoV-2 spike protein, developed by Oxford
University’s Jenner institute working with the Oxford Vaccine
Group.
AstraZeneca’s AZD1222 is one of several candidates 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 for Americans
by January 2021. As part of OWS, Emergent will provide development
and manufacturing services and capacity to innovators of leading
COVID-19 vaccine candidates selected by the U.S. government, such
as AstraZeneca.
“By partnering with leading innovators like AstraZeneca,
Emergent is playing a critical role in increasing the world’s
chances of having a safe and effective COVID-19 vaccine,” said
Robert G. Kramer Sr., president and chief executive officer of
Emergent BioSolutions. “We are proud to provide our CDMO services
to advance AstraZeneca’s COVID-19 vaccine candidate. With this
agreement, we bring to our facilities two of the five leading
candidates being developed with U.S. government funding."
Under the agreement, valued at approximately $87 million,
Emergent will provide development services, technology transfer,
analytical testing, drug substance process and performance
qualification and will reserve certain large-scale manufacturing
capacity through 2020.
“As both a manufacturer of our own vaccines and a service
provider, Emergent is uniquely equipped to take on the integral
role of development and manufacturing partner to companies like
AstraZeneca with lead vaccine candidates for COVID-19,” said Syed
T. Husain, senior vice president and CDMO business unit head at
Emergent. “We have spent decades establishing a strong, integrated
CDMO network that allows us to dependably and consistently produce
life-saving medicines for our company and for others
worldwide.”
Development services will be provided out of Emergent’s
Gaithersburg product development facility. Large-scale
manufacturing of drug substance will be done at the Baltimore
Bayview facility, an HHS-designated Center for Innovation in
Advanced Development and Manufacturing (CIADM) designed for rapid
manufacturing of large quantities of vaccines and treatments during
public health emergencies.
Emergent’s Bayview facility 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.
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 at least one of the 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. 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 Q3 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. Prior to
the launch of Operation Warp Speed, the company had announced
earlier collaborations with three 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, as well as the negotiation of
another contract related to the second phase of 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,
Corporate Communications240-631-3392NeriM@ebsi.com
Investor Contact:Robert G. BurrowsVice
President, Investor Relations240-631-3280BurrowsR@ebsi.com
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