Emergent BioSolutions Inc. (NYSE:EBS) and Providence Therapeutics
today announced they have entered into a five-year contract
development and manufacturing (CDMO) services agreement spanning
Emergent’s integrated capabilities, including development services,
bulk drug substance formulation and drug product manufacturing, to
support Providence’s COVID-19 messenger RNA (mRNA) vaccine
development. In 2022, Emergent will manufacture tens of millions of
doses of PTX-COVID19-B drug product, as well as batches of
PTX-COVID19-B formulated bulk drug substance with the potential to
yield hundreds of millions more doses, for global populations in
need of pandemic relief.
Under the terms of the five-year agreement,
Emergent will provide current Good Manufacturing Practice (cGMP)
manufacturing services for two presentations of the PTX-COVID19-B
vaccine product, both the formulated bulk drug substance and
finished drug product (fill/finish), at Emergent’s facility in
Winnipeg, MB, Canada. Additional process and analytical development
services will occur from Emergent’s Center of Excellence for
Development Services in Gaithersburg, Maryland. The baseline
agreement signed between Emergent and Providence Therapeutics is
valued at approximately $90 million, covering manufacturing
services, studies to support global supply chain activities, as
well as facility and equipment investments.
“Emergent’s commitment to fight the COVID-19
pandemic is anchored in our partnerships with innovators who share
the same mission to address public health threats around the
world,” said Adam R. Havey, executive vice president and chief
operating offer at Emergent BioSolutions. “This collaboration is a
testament to Emergent’s long heritage and experience in Canada. We
are proud that Providence has chosen our Winnipeg team and site to
manufacture its Canadian mRNA technology in Western Canada, one of
the few facilities in the country manufacturing large quantities of
mRNA COVID-19 vaccine doses today.”
As commented by Brad Sorenson, Providence CEO,
“Providence is very pleased to have the resources necessary to ramp
up commercial manufacturing of its COVID vaccine here in Canada. We
look forward to working side-by-side with Emergent to deliver tens
of millions, and potentially hundreds of millions of doses of our
world-class vaccine to developing countries across the globe. It
has always been Providence’s mission to produce the highest quality
medicines at affordable prices, and with Emergent’s help we are
closer to achieving this goal.”
To date, Emergent has partnered with numerous
pharmaceutical and biotech innovators, as well as the U.S.
government and non-government organizations in providing critical
contract manufacturing services (drug substance manufacturing, drug
product manufacturing and development services) in response to the
COVID-19 pandemic.
About Emergent
BioSolutionsEmergent BioSolutions is a global life
sciences company whose mission is to protect and enhance life.
Through Emergent’s specialty products and contract development and
manufacturing services, Emergent is dedicated to providing
solutions that address public health threats. Through social
responsibility, Emergent aims to build healthier and safer
communities. Emergent aspires to deliver peace of mind to its
patients and customers so they can focus on what’s most important
in their lives. In working together, Emergent envisions protecting
or enhancing 1 billion lives by 2030. For additional information,
visit Emergent’s website and follow Emergent on LinkedIn, Twitter
and Instagram.
About Providence
Therapeutics
Providence Therapeutics is Canada’s leading mRNA
vaccine company, with operations in Calgary, Alberta and Toronto,
Ontario. In response to a worldwide need for a COVID-19 vaccine,
Providence has expanded its focus beyond oncology and devoted its
energy and resources to develop a world-class mRNA vaccine for
COVID-19. Providence Therapeutics is focused on serving the needs
of Canada, and other countries that may be underserved by large
pharma programs. For more information, please visit
providencetherapeutics.com.
Emergent BioSolutions Safe Harbor
Statement
This 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 Emergent’s
ability to advance potential solutions to combat coronavirus
disease and manufacture tens of millions of doses of PTX-COVID19-B
drug product and formulated bulk drug substance, the timing of
production of such doses and the potential to yield hundreds of
millions additional doses and any other statements containing the
words “believes,” “expects,” “anticipates,” “intends,” “plans,”
“estimates” and similar expressions, are forward-looking
statements. These forward-looking statements are based on current
intentions, beliefs and expectations regarding future events.
Emergent cannot guarantee that any forward-looking statement will
be accurate. The reader should realize that if underlying
assumptions prove inaccurate or unknown risks or uncertainties
materialize, actual results could differ materially from
expectations. The reader is, 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, Emergent does 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 Emergent’s actual results to differ
materially from those indicated by such forward-looking statements,
including, but not limited to, the success of the planned
development program, the timing of and ability to obtain and
maintain regulatory approvals or authorization for emergency or
broader patient use for the product candidate and Emergent’s
manufacturing capabilities. The foregoing sets forth many, but not
all, of the factors that could cause actual results to differ from
expectations in any forward-looking statement. The reader should
consider this cautionary statement, as well as the risk factors
identified in Emergent’ periodic reports filed with the SEC, when
evaluating Emergent’s forward-looking
statements.
Providence Therapeutics Forward-Looking
Statement
This press release contains forward-looking
statements within the meaning of applicable securities laws
including regarding the Providence's development of a potential
vaccine against COVID-19. The forward-looking statements in this
press release are neither promises nor guarantees, and you should
not place undue reliance on these forward-looking statements
because they involve known and unknown risks, uncertainties, and
other factors, many of which are beyond Providence's control, and
which could cause actual results to differ materially from those
expressed or implied by these forward-looking statements. These
risks, uncertainties, and other factors include, among others: the
fact that the safety and efficacy of PTX-COVID19-B has not yet been
established; potential adverse impacts due to the global COVID-19
pandemic such as delays in regulatory review, manufacturing and
supply chain interruptions, adverse effects on healthcare systems
and disruption of the global economy; the fact that there are a
limited number of commercial products utilizing mRNA technology
approved for use; and the fact that the mRNA technology in use by
Providence is still being developed and implemented. Except as
required by law, Providence disclaims any intention or
responsibility for updating or revising any forward-looking
statements contained in this press release in the event of new
information, future developments or otherwise. These
forward-looking statements are based on Providence's current
expectations and speak only as of the date hereof.
Emergent BioSolutions
Contacts:
Media Contact:Matt
HartwigDirector, Media Relationshartwigm@ebsi.com
Investor Contact:Robert G.
BurrowsVice President, Investor
Relations240-631-3280burrowsr@ebsi.com
Providence Therapeutics
Contacts: Neil ForesterPresidentThe Substance
Group416-722-3793media@thesubstancegroup.com
Noy WongInvestor Relations &
CommunicationsProvidence Therapeutics Holdings
Inc.Media.reach@providencetherapeutics.com
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