Moderna, Inc. (Nasdaq: MRNA), a clinical stage biotechnology
company pioneering messenger RNA (mRNA) therapeutics and vaccines
to create a new generation of transformative medicines for
patients, 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 a
collaboration for large-scale, commercial fill-finish manufacturing
of Moderna’s mRNA-based COVID-19 vaccine candidate (mRNA-1273) at
Catalent’s biologics facility in Bloomington, Indiana.
As part of the agreement, Catalent will provide vial filling and
packaging capacity, as well as additional staffing required for
24x7 manufacturing operations at the site to support production of
an initial 100 million doses of the vaccine candidate intended to
supply the U.S. market starting in the third quarter of 2020. The
companies are in discussions to secure fill-finish capacity for
continued production of hundreds of millions of additional
doses.
Catalent will also provide clinical supply services from its
facilities in Philadelphia, Pennsylvania, including packaging and
labeling, as well as storage and distribution to support Moderna’s
Phase 3 clinical study for this candidate.
“We appreciate this collaboration with Catalent and the
flexibility of their team to deliver critical fill-finish capacity
for mRNA-1273 at unprecedented speed,” said Juan Andres, Moderna’s
Chief Technical Operations and Quality Officer. “It has been
wonderful to see both teams working together to support the common
good.”
“Catalent is proud to partner with Moderna in its work to
address this critical public health need,” commented John
Chiminski, Chair and Chief Executive Officer of Catalent.
“Catalent’s proven expertise in manufacturing scale-up and
commercial production are well suited to support Moderna’s efforts
to prepare for wide-scale supply of this vaccine candidate so that
it is available if appropriate to address the pandemic.”
Catalent’s state-of-the-art 875,000 square-foot biologics
facility in Bloomington will undertake this vial filling work under
barrier isolator technology. Moderna will leverage the site’s
recent packaging expansion, which provides fully automated and
high-speed packaging capabilities to accelerate manufacturing
timelines. The facility has deep expertise in sterile formulation,
with drug substance development and manufacturing and drug product
fill-finish capacity across liquid and lyophilized vials, prefilled
syringes, and cartridges, as well as primary and secondary
packaging. In addition to its Bloomington location, the Catalent
Biologics network has facilities in Brussels, Belgium and Anagni,
Italy that perform sterile drug product manufacturing and
packaging, and in the United States and Europe for manufacturing
proteins, viral vectors for gene therapies and cell therapies, as
well as providing pre-filled syringe manufacture and biologics
analytical services.
About mRNA-1273, Moderna’s Vaccine Candidate Against
COVID-19
mRNA-1273 is an mRNA vaccine candidate against COVID-19 encoding
for a prefusion stabilized form of the Spike (S) protein, which was
selected by Moderna in collaboration with investigators from
Vaccine Research Center (VRC) at the National Institute of Allergy
and Infectious Diseases (NIAID), a part of the National Institutes
of Health (NIH). On June 11, 2020, Moderna announced that
enrollment of younger adults (n=300) and the sentinel group of
older adults (n=50) in its Phase 2 study of mRNA-1273 was complete,
and that its Phase 3 study of approximately 30,000 participants, is
expected to begin in July 2020.
About Moderna
Moderna is advancing messenger RNA (mRNA) science to create a
new class of transformative medicines for patients. mRNA medicines
are designed to direct the body’s cells to produce intracellular,
membrane or secreted proteins that can have a therapeutic or
preventive benefit and have the potential to address a broad
spectrum of diseases. The company’s platform builds on continuous
advances in basic and applied mRNA science, delivery technology and
manufacturing, providing Moderna the capability to pursue in
parallel a robust pipeline of new development candidates. Moderna
is developing therapeutics and vaccines for infectious diseases,
immuno-oncology, rare diseases, cardiovascular diseases, and
autoimmune and inflammatory diseases, independently and with
strategic collaborators.
Headquartered in Cambridge, Mass., Moderna currently has
strategic alliances for development programs with AstraZeneca PLC
and Merck & Co., Inc., as well as the Defense Advanced Research
Projects Agency (DARPA), an agency of the U.S. Department of
Defense, and Biomedical Advanced Research and Development Authority
(BARDA), a division of the Office of the Assistant Secretary for
Preparedness and Response (ASPR) within the U.S. Department of
Health and Human Services (HHS). Moderna has been named a top
biopharmaceutical employer by Science for the past five 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 over 13,500 people,
including over 2,400 scientists and technicians, at more than 40
facilities, and in fiscal year 2019 generated over $2.5 billion in
annual revenue. Catalent is headquartered in Somerset, New Jersey.
For more information, visit www.catalent.com.
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 regarding the Company’s development of
a potential vaccine against the novel coronavirus, the number of
doses per year targeted for manufacturing under the agreement with
Catalent, the Company’s manufacturing efforts, the expected funding
for clinical studies and manufacturing activities, and the
parameters and timing of the planned Phase 3 study of mRNA-1273. 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 manufacturing
infrastructure required to manufacture mRNA-1273 by Moderna is
still being developed and implemented; the fact that the safety and
efficacy of mRNA-1273 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; 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 development, success, and
administration of clinical trials, ability to launch and future
manufacturing 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 proposed vaccine, any competing vaccine, or any treatment
for COVID-19, competitor responses to a potential future launch of
this vaccine, 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 the vaccine, fluctuations in currency exchange rates
that affect Catalent’s ability to source the materials needed for
the production of the product, 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, 2019 and its Quarterly Report on Form 10-Q for the quarter
ended March 31, 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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Moderna
Media: Colleen Hussey Senior Manager, Corporate Communications
203-470-5620 Colleen.Hussey@modernatx.com
Dan Budwick 1AB 973-271-6085 Dan@1abmedia.com
Investors: Lavina Talukdar Head of Investor Relations
617-209-5834 Lavina.Talukdar@modernatx.com
Catalent
Media: Chris Halling +44 (0)7580 041073
chris.halling@catalent.com
Richard Kerns +44 (0) 161 728 5880 richard@nepr.agency
Investors Paul Surdez +1 (732) 537-6325
investors@catalent.com
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