Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering
messenger RNA (mRNA) therapeutics and vaccines, and Catalent, Inc.
(NYSE: CTLT), the leading global provider of advanced delivery
technologies, development, and manufacturing solutions for drugs,
biologics, cell and gene therapies, and consumer health products,
today announced the expansion of their strategic collaboration to
dedicate a new high-speed vial filling line for the manufacture of
the Moderna COVID-19 Vaccine and potentially other investigational
programs in Moderna’s pipeline, at Catalent’s biologics facility in
Bloomington, Indiana.
In June 2020, Catalent and Moderna announced that Catalent would
provide aseptic vial filling and packaging from its Bloomington
site, including additional staffing required for 24x7 manufacturing
to support production of an initial 100 million doses of Moderna’s
vaccine. On March 29, Moderna announced that this significant
milestone was achieved.
As part of this expanded agreement, Catalent will now dedicate
to Moderna’s use a new high-speed filling line at the site through
June 2023, which can be used to manufacture the COVID-19 vaccine
and potentially additional investigational programs in Moderna’s
large clinical pipeline. Catalent will also provide inspection,
labeling, cartoning, and final packaging for these programs.
“We appreciate this expanded collaboration with Catalent and the
dedication of their team,” said Juan Andres, Moderna’s Chief
Technical Operations and Quality Officer. “This additional
fill-finish capacity will be important for not only our COVID-19
vaccine, but also potentially for other programs in our clinical
development pipeline.”
“Catalent’s partnership with Moderna began in 2016, when we had
only glimpsed the potential applications of mRNA and could not have
guessed how pivotal mRNA would become in the fight against
COVID-19,” commented Alessandro Maselli, Catalent’s President and
Chief Operating Officer. “We are proud to announce this extension
of our companies’ strategic collaboration, and we look forward to
further demonstrating our commercial manufacturing expertise as we
help supply more vaccine doses.”
Catalent announced in September 2020 its $50 million investment
into this third high-speed vial filling line at Bloomington. Due to
the company’s considerable experience in facility and capacity
expansion, it was able to accelerate the overall project from a
typical 18-month timeframe to approximately 10 months, including
construction, procurement, installation, and CGMP qualification of
the line, which will be completed in April 2021. Furthermore, the
ability to dedicate this new line to Moderna will enable the site
to free-up capacity on existing lines for other important customer
programs.
About Moderna
In 10 years since its inception, Moderna has transformed from a
science research-stage company advancing programs in the field of
messenger RNA (mRNA), to an enterprise with a diverse clinical
portfolio of vaccines and therapeutics across six modalities, a
broad intellectual property portfolio in areas including mRNA and
lipid nanoparticle formulation, and an integrated manufacturing
plant that allows for both clinical and commercial production at
scale and at unprecedented speed. Moderna maintains alliances with
a broad range of domestic and overseas government and commercial
collaborators, which has allowed for the pursuit of both
groundbreaking science and rapid scaling of manufacturing. Most
recently, Moderna’s capabilities have come together to allow the
authorized use of one of the earliest and most-effective vaccines
against the COVID-19 pandemic.
Moderna’s mRNA platform builds on continuous advances in basic
and applied mRNA science, delivery technology and manufacturing,
and has allowed the development of therapeutics and vaccines for
infectious diseases, immuno-oncology, rare diseases, cardiovascular
diseases and auto-immune diseases. Today, 24 development programs
are underway across these therapeutic areas, with 13 programs
having entered the clinic. Moderna has been named a top
biopharmaceutical employer by Science for the past six years. To
learn more, visit www.modernatx.com.
About Catalent
Catalent is the leading global provider of advanced delivery
technologies, development, and manufacturing solutions for drugs,
biologics, cell and gene therapies, and consumer health products.
With over 85 years serving the industry, Catalent has proven
expertise in bringing more customer products to market faster,
enhancing product performance and ensuring reliable global clinical
and commercial product supply. Catalent employs approximately
15,000 people, including over 2,400 scientists and technicians, at
more than 45 facilities, and in fiscal year 2020 generated over $3
billion in annual revenue. Catalent is headquartered in Somerset,
New Jersey. For more information, visit www.catalent.com
More products. Better treatments. Reliably supplied.™
Moderna’s Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including statements regarding: Moderna’s
development of a vaccine (mRNA-1273) to protect against the
SARS-CoV-2 virus, which causes COVID-19; the strategic
collaboration between Moderna and Catalent for the filling and
finishing of Moderna’s COVID-19 Vaccine and other investigational
products; and the terms of that collaboration and implications for
production of the Moderna COVID-19 Vaccine. In some cases,
forward-looking statements can be identified by terminology such as
“will,” “may,” “should,” “could,” “expects,” “intends,” “plans,”
“aims,” “anticipates,” “believes,” “estimates,” “predicts,”
“potential,” “continue,” or the negative of these terms or other
comparable terminology, although not all forward-looking statements
contain these words. 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 Moderna’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 there has never been a commercial product utilizing mRNA
technology approved for use; the fact that the rapid response
technology in use by Moderna is still being developed and
implemented; the safety, tolerability and efficacy profile of the
Moderna COVID-19 Vaccine observed to date may change adversely in
ongoing analyses of trial data or subsequent to commercialization;
the Moderna COVID-19 Vaccine may prove less effective against
variants of the SARS-CoV-2 virus, or Moderna may be unsuccessful in
developing future versions of its vaccine against these variants;
despite having ongoing interactions with the FDA or other
regulatory agencies, the FDA or such other regulatory agencies may
not agree with Moderna’s regulatory approval strategies, components
of our filings, such as clinical trial designs, conduct and
methodologies, or the sufficiency of data submitted; Moderna may
encounter delays in meeting manufacturing or supply timelines or
disruptions in its distribution plans for the Moderna COVID-19
Vaccine; whether and when any biologics license applications and/or
additional emergency use authorization applications may be filed in
various jurisdictions and ultimately approved by regulatory
authorities; potential adverse impacts due to the global COVID-19
pandemic such as delays in regulatory review, manufacturing and
clinical trials, supply chain interruptions, adverse effects on
healthcare systems and disruption of the global economy; and those
other risks and uncertainties described under the heading “Risk
Factors” in Moderna’s most recent Annual Report on Form 10-K filed
with the U.S. Securities and Exchange Commission (SEC) and in
subsequent filings made by Moderna with the SEC, which are
available on the SEC’s website at www.sec.gov. Except as required
by law, Moderna 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 Moderna’s current expectations and speak only as of the
date hereof.
Catalent’s Forward-Looking Statements
Statements concerning the finalization and future manufacturing
capacity of Catalent’s production lines contained in this release
are forward-looking statements. They involve known and unknown
risks, uncertainties, and other factors that may cause actual
results or performance to be different from those expressed or
implied in this release. Catalent has based its forward-looking
statements on its current expectations, assumptions, estimates and
projections, which it believes to be reasonable, but various
factors, including factors beyond Catalent’s control, may affect
future results or performance. Among the factors that may affect
these forward-looking statements are: the rapidly changing market
for treatments and vaccines to address the COVID-19 pandemic, the
current or future effects of the COVID-19 pandemic, including its
effects on Catalent’s and its clients’ businesses, the outcome of
the development of this or any competing vaccine or any treatment
for COVID-19, the outcome of any and all reviews, inspections, or
other approvals by the U.S. Food and Drug Administration (FDA) or
similar regulatory health authority, customer and payor acceptance
of the vaccine, any competing vaccine, or any treatment for
COVID-19, competitor responses to potential future expansion of
vaccine production, changes to the overall economic climate in the
United States or among potential purchasers of the product, changes
to the healthcare reimbursement system in the United States or
elsewhere, competing initiatives at Catalent or Moderna, supply
chain risks relating to production on this line, fluctuations in
currency exchange rates that affect Catalent’s ability to source
the materials needed for production, or potential third-party
claims or litigation related to the vaccine. These and other
important factors, including those discussed under “Risk Factors”
in the Catalent, Inc. Annual Report on Form 10-K for the year ended
June 30, 2020, may affect future results or performance. Catalent
makes the statements in this release only as of the date of this
release, and Catalent disclaims any duty, except as required by
law, to update or revise any forward-looking statement, regardless
of the circumstances.
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version on businesswire.com: https://www.businesswire.com/news/home/20210406005617/en/
Catalent Media: Chris Halling +44 (0)7580 041073
chris.halling@catalent.com Richard Kerns +44 (0) 161 728 5880
richard@nepr.agency Catalent Investors: Paul Surdez +1 (732)
537 6325 Moderna Media: Colleen Hussey Director, Corporate
Communications 617-335-1374 colleen.hussey@modernatx.com Moderna
Investors: Lavina Talukdar SVP & Head of Investor Relations
617-209-5834 lavina.talukdar@modernatx.com
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