Catalent Signs Agreement with AstraZeneca to Manufacture COVID-19 Vaccine Candidate

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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