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Moderna and Samsung Biologics Announce Agreement for Fill-Finish Manufacturing of Moderna’s COVID-19 Vaccine

May 22, 2021 Off By BusinessWire

The agreement will further enable global supply of mRNA-1273, Moderna’s COVID-19 vaccine with Samsung Biologics’ fill and finish manufacturing service

CAMBRIDGE, Mass. & INCHEON, South Korea–(BUSINESS WIRE)–Moderna (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Samsung Biologics (KRX: 207940.KS), a leading global CDMO providing a fully integrated end-to-end contract development and manufacturing service, today announced a Manufacturing Services and Supply Agreement in which Samsung Biologics will provide large scale, commercial fill-finish manufacturing for mRNA-1273, Moderna’s COVID-19 vaccine.

Upon execution of the deal, technology transfer will commence immediately at Samsung Biologics’ facilities in Incheon, South Korea, utilizing a state-of-the-art production line equipped for aseptic fill-finish, labeling, and packaging services to support the production of hundreds of millions of doses of Moderna’s COVID-19 vaccine intended for the supply of markets outside of the U.S. starting in the third quarter of 2021.

“This vaccine is paramount to people around the world in the fight against the COVID-19 pandemic, and we truly appreciate our client Moderna for entrusting and choosing to partner with Samsung Biologics for the fill and finish of this important vaccine,” said John Rim, CEO of Samsung Biologics. “Due to the high level of urgency in supplying the vaccine to the global population, we have set immediate action plans and schedule to make mRNA-1273 available for commercial distribution in the early second half of 2021.”

“We are pleased to partner with Samsung Biologics for this fill and finish manufacturing, which will help us continue to scale up our manufacturing capacity outside of the U.S.,” said Juan Andres, Moderna’s Chief Technical Operations and Quality Officer. “We and our manufacturing partners remain committed to defeating the COVID-19 pandemic.”

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 14 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 Samsung Biologics Co., Ltd.

Samsung Biologics (KRX: 207940.KS) is a fully integrated CDMO offering state-of-the-art contract development, manufacturing, and laboratory testing services. With proven regulatory approvals, the largest capacity, and the fastest throughput, Samsung Biologics is an award-winning partner of choice and is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide. For more information, visit www.samsungbiologics.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 Moderna’s development of a vaccine against SARS-CoV-2 (mRNA-1273), and an arrangement pursuant to which Samsung Biologics will provide fill/finish sterile manufacturing services and packaging for the Moderna COVID-19 Vaccine, and the timing and scale for those services. 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; 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; 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 emergency use authorization applications may be filed 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.

Samsung Biologics Forward-Looking Statements

This press release contains certain statements that constitute forward-looking statements, including statements that describe Samsung Biologics’ objectives, plans or goals. All such forward-looking statements, and the assumptions on which they are based, are subject to certain risks and uncertainties that could cause actual results to differ materially from those contemplated by the relevant forward-looking statements. There can be no assurance that the results and events contemplated by the forward-looking statements contained herein will in fact occur. Except as required by law, Samsung Biologics will not update any forward-looking statements to reflect material developments that may occur after the date of this press release.