MODERNA AND NOVOCOL PHARMA ANNOUNCE FILL-FINISH AGREEMENT FOR CANADIAN-MADE MRNA VACCINES

Vaccines manufactured at Moderna's state-of-the-art Canadian mRNA facility to be prepared and packaged at Novocol's Ontario-based facility

Fill-finish agreement will secure domestic end-to-end vaccine production and ensures rapid response capabilities for future pandemic readiness for Canadians

TORONTO, May 4, 2023 /CNW/ - Moderna, Inc.(NASDAQ: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced a long-term agreement with Ontario-based Novocol Pharma, a leading sterile injectable contract development and manufacturing organization (CDMO), to perform aseptic fill-finish, labelling and packaging of mRNA respiratory vaccines expected to be produced in Canada. Fill-finish sterile manufacturing is the final step in the production cycle and includes transferring the vaccine drug product into vials and packaging them for use.

The agreement with Novocol Pharma will result in the fill-finish capacity of vaccines manufactured at Moderna's Laval-based mRNA facility, which is expected to become operational by the end of 2024, subject to planning and regulatory approvals.

To assist with the creation of highly sophisticated manufacturing capabilities necessary to fill and finish the mRNA vaccines, the Government of Ontario, through the Ontario Together Fund, has provided a grant to Moderna. The partnership with Novocol Pharma also supports Canada's Ministry of Innovation, Science and Economic Development (ISED) strategic investments to provide onshore respiratory vaccine manufacturing capabilities and support national pandemic readiness for all Canadians.

The agreement also expands Moderna's footprint and investment in Ontario to help make available mRNA vaccines for all Canadians and to support high-skilled jobs in this growing sector. Together with the new facility in Laval and partnerships with local universities and biotech start-ups, Moderna is helping to drive Canada's position as an mRNA centre of excellence.

Moderna's mRNA pipeline includes 47 programs, including vaccines against respiratory viruses, vaccines against latent viruses, and vaccines against threats to global public health.

"Canada's scientific expertise and biomanufacturing capabilities make it a key and strategic country for Moderna as we expand our mRNA technology capabilities globally. Novocol Pharma exemplifies best-in-class experience, capabilities, manufacturing systems, and controls required to prepare our mRNA vaccines and scale up production as needed to address novel or emerging viruses."  Jerh Collins, Chief Technical Operations and Quality Officer, Moderna

"Moderna is pleased to be growing a bigger presence in Ontario through our agreement with Novocol Pharma, thanks in part to the important contribution from the Government of Ontario. Today's announcement complements our activities in Quebec and contributes to Moderna's long-term partnership with the Federal Government to provide onshore respiratory vaccine manufacturing capabilities and support national pandemic readiness for all Canadians."  Patricia Gauthier, President and General Manager of Moderna Canada

"Novocol Pharma, a Septodont company, is honored to be Moderna's fill-finish partner for domestic production of vaccines. Our partnership is a synergy of capabilities between our respective organizations. Together, we will strengthen Canada's domestic supply chain for the production of vaccines and pandemic preparedness. This achievement has been made possible through collaboration between the private and the public sector, at both provincial and federal levels." Atif Zia, Chief Operating Officer of Septodont and President of Novocol Pharma

"Moderna's new investment is a huge vote of confidence in our province, our workers, and our growing life sciences sector. Not only will this investment create good paying jobs, it will provide our health care workers and people with more reliable access to life-saving vaccines, helping to ensure we no longer have to rely on other jurisdictions to keep us safe." The Honourable Doug Ford, Premier of Ontario

"Through the Ontario Together Fund, we continue to grow our life sciences sector and help Ontario businesses innovate and bring their ideas to market. Our government is proud to partner with companies like Moderna and Novocol Pharma as they help make Ontario home to the next generation of medical technology solutions. Expanding our biomanufacturing capacity will help ensure we have a strong medical supply chain today and in the future." The Honourable Vic Fedeli, Minister of Economic Development, Job Creation and Trade

"By building homegrown capacity to produce life-saving vaccines, Ontario will no longer need to rely on other countries to keep our communities safe. This partnership between Moderna and Novocol Pharma will create good paying jobs for the Cambridge community and help shore up our domestic production of vaccines to ensure faster access in the event of a future public health challenge." The Honourable Sylvia Jones, Deputy Premier and Minister of Health

"This partnership between Moderna and Novocol is a prime example of how our government's Biomanufacturing and Life Sciences Strategy is working. From the production of cutting-edge mRNA vaccines in Moderna's Laval facility to filling and packaging them at Novocol's facility in Cambridge, this collaboration is further anchoring a competitive life sciences sector across the country. Not only are we preparing Canada to respond to future pandemics and other health emergencies, we are also strengthening our economy and creating good jobs for Canadians." The Honourable François-Philippe Champagne, Minister of Innovation, Science and Industry

"To strengthen health science innovation and prepare for future pandemics and health emergencies, we must build on our domestic vaccine manufacturing capability. The new agreement between Moderna and Novocol Pharma will help us achieve just that while ensuring Canadians have timely access to world-class vaccines made right here in Canada for years to come." The Honourable Jean-Yves Duclos, Minister of Health

"Novocol Pharma has been an exemplary part of the Cambridge community for over 45 years, and I am very pleased that this partnership with Moderna, a world-leading life sciences innovator, is coming to fruition. This partnership between government and the private sector is helping to cement Ontario's status as a cutting-edge global hub for the biomanufacturing and life sciences sector, and this investment will bring exciting economic growth and great new jobs to Cambridge." Bryan May, Parliamentary Secretary to the Minister of National Defence and Member of Parliament for Cambridge

In over 10 years since its inception, Moderna has transformed from a 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 seven modalities, a broad intellectual property portfolio and integrated manufacturing facilities that allow for rapid clinical and commercial production at scale. 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 and approval of one of the earliest and most effective vaccines against the COVID 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. Moderna has been named a top biopharmaceutical employer by Science for the past eight years. To learn more, visit www.modernatx.com.

Novocol Pharmaceutical of Canada Inc. (doing business as Novocol Pharma) is a proud member of the Septodont Group of companies privately held by the Schiller family in France and employing 2000 employees worldwide. Novocol is a well-established sterile injectable fill-finish organization with over 500 highly skilled employees and operating in Cambridge, Ontario, for 45 years.

With a long history of serving global markets with sterile injectable dental anesthetics, the company serves global biopharmaceutical and pharmaceutical partners as an embedded contract development and manufacturing organization (CDMO) specializing in aseptic fill-finish. Novocol's CDMO service offerings include clinical and commercial scale sterile fill-finish, product development and analytical services, combination product assembly and drug delivery system design. For more information, please visit www.novocolpharma.com.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: an agreement with Novocol Pharma to perform aseptic fill-finish, labelling, and packaging of mRNA respiratory vaccines expected to be produced in Canada; Moderna's agreement with the Canadian government to develop an mRNA manufacturing facility in Canada; expected timing for commencing construction of the facility, and when the facility is expected to be operational. 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 those other risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2022, 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 of this press release.

SOURCE Moderna, Inc.