Emergent BioSolutions Signs Five-Year Agreement for Large-Scale Drug Substance Manufacturing for Johnson & Johnson’s Lead C...
July 06 2020 - 6:30AM
Emergent BioSolutions Inc. (NYSE:EBS) today announced a five-year
manufacturing services agreement with Janssen Pharmaceuticals,
Inc., one of the Janssen Pharmaceutical Companies of Johnson &
Johnson, for large-scale drug substance manufacturing for Johnson
& Johnson’s investigational SARS-CoV-2 vaccine, Ad26.COV2-S,
recombinant based on the AdVac® technology. Emergent will provide
contract development and manufacturing (CDMO) services to produce
drug substance at large scale over five years, valued at
approximately $480 million for the first two years.
“We are proud to deploy our manufacturing strength to address
the COVID-19 pandemic,” said Robert G. Kramer Sr., president and
chief executive officer of Emergent BioSolutions. “Advancing this
collaboration is one of the ways we live our mission – to protect
and enhance life.”
Under the agreement, Emergent will begin providing large-scale
drug substance manufacturing for Johnson & Johnson’s
adenovirus-based COVID-19 vaccine in 2021, upon successful
completion of the activities under the previously executed
Technology Transfer Agreement. For the subsequent years beginning
2023, Emergent will provide a flexible capacity deployment model to
support additional drug substance batches annually.
“Over the next five years, we are committing our leading CDMO
services to advance this important vaccine candidate,” said Syed T.
Husain, senior vice president and CDMO business unit head at
Emergent. “We have the expertise and capabilities to meet the
long-term needs of our customers and provide ongoing commercial
manufacturing to benefit patients.”
This long-term large-scale manufacturing agreement follows and
is incremental to the contract announced in April for drug
substance manufacturing technology transfer services and for
reserving certain large-scale manufacturing capacity to pave the
way for commercial drug substance manufacturing for the COVID-19
vaccine candidate.
Activities will be performed at Emergent’s Baltimore Bayview
facility, 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.
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 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. 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, meet annual dosage requirements in the
anticipated timeline and pave the potential pathway to licensure
and commercial manufacturing of these candidates, 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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