Catalent Signs Agreement with AstraZeneca to Manufacture COVID-19 Vaccine Candidate
June 15 2020 - 7:30AM
Business Wire
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 that Catalent Biologics
will provide vial filling and packaging capacity to AstraZeneca PLC
at Catalent’s manufacturing facility in Anagni, Italy, and prepare
for large-scale commercial supply of the University of Oxford’s
adenovirus vector based COVID-19 vaccine candidate, AZD1222.
The agreement accelerates the rapid scale-up of capacity over
the coming months to support the dedicated production of AZD1222.
Catalent will prepare the facility to enable round-the-clock
manufacturing schedules and supply hundreds of millions of doses of
the vaccine candidate from August 2020, and potentially through to
March 2022 should the product be approved by regulatory
agencies.
The recombinant adenovirus vaccine technology was created by the
Jenner Institute at the University of Oxford, and the vaccine
candidate is currently in clinical trials.
"Catalent has significant experience in the tech transfer and
rapid scale-up of vaccine programs to meet demand," commented
Alessandro Maselli, President & Chief Operating Officer of
Catalent. He added, “Our manufacturing site in Anagni, Italy has
served for many years as a primary launch facility for new
medicines, and the plant’s skilled team will take great pride in
preparing to manufacture this vaccine candidate for COVID-19 and
ensuring that the product will be able to reach patients as quickly
as possible if approved.”
Catalent’s 28,000 square-meter (305,000 square-foot) facility in
Anagni has a demonstrated track record in technical transfers and
successful commercial product launches. It offers extensive
capabilities in aseptic liquid filling for biologics and sterile
products across multiple vial sizes. The site also provides
comprehensive primary and secondary packaging solutions, including
serialization, to support product launches for oral solids,
sterile, and biologics products. In addition to the Anagni
facility, Catalent’s Biologics network includes sterile drug
product manufacturing and packaging facilities in Brussels, Belgium
and Bloomington, Indiana, and additional facilities in Europe and
the United States for manufacturing proteins, viral vectors for
gene therapies and cell therapies, and biologics analytical
services.
About Catalent
Catalent, Inc. (NYSE: CTLT) 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
More products. Better treatments. Reliably supplied.™
Forward-Looking Statement
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
regions where this product may be marketed or among potential
purchasers of the product, changes to the healthcare reimbursement
system in the regions where this product may be marketed or
elsewhere, competing initiatives at Catalent or AstraZeneca, 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 or 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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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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