Press Release: Novartis breaks ground on flagship manufacturing hub in North Carolina

-- FDA Commissioner Marty Makary, North Carolina Governor Josh Stein and

Novartis leadership highlight importance of new hub to US patients and

local economy

-- Construction reflects company's commitment to ensure end-to-end

manufacturing of all key medicines for US patients in the US at scale

-- Groundbreaking marks continuation of Novartis investment and growth in

the US, capping year of significant regulatory and manufacturing

milestones

East Hanover, December 12, 2025 -- Novartis, a leading global innovative medicines company, broke ground yesterday on its more than 700,000-square-foot flagship manufacturing hub in North Carolina, moving rapidly to construct its recently announced https://www.novartis.com/us-en/news/media-releases/novartis-announces-plans-build-flagship-manufacturing-hub-north-carolina investment in the state.

The North Carolina project will include the construction of a new facility in Morrisville and a new site in Durham encompassing two new facilities, as well as the expansion of an existing Novartis facility in Durham. Together, these investments are expected to create 700 new jobs in North Carolina by 2030 and support more than 3,000 indirect jobs across the Novartis US supply chain. This expansion is a key pillar in the company's $23 billion investment https://www.novartis.com/us-en/about/investing-americas-health in US-based infrastructure over the next five years.

US Food and Drug Administration Commissioner Marty Makary, MD, MPH, North Carolina Governor Josh Stein and other elected officials from the state, joined Novartis leadership and employees and members of the local community to celebrate the official start of construction of the manufacturing hub.

"It's an exciting day for Novartis as we break ground on our new manufacturing hub, a crucial step toward delivering on our goal of producing all our key medicines for US patients domestically," said Vas Narasimhan, CEO of Novartis. "Once complete, this new hub will become a central site for Novartis manufacturing in the US, strengthening our supply chain and underscoring our commitment to American patients."

With construction now underway, Novartis is strengthening its coast-to-coast manufacturing and research network, enabling full end-to-end manufacturing capabilities across its main therapeutic areas, supporting the delivery of its key medicines to patients across the US at scale.

"North Carolina continues to lead in cutting-edge life sciences," said NC Governor Josh Stein. "Novartis' decision to deepen its roots here speaks to the strength of our talent, our research universities, and our commitment to leading the nation in advanced pharmaceutical manufacturing. These investments bring in more good-paying jobs for North Carolinians and build a stronger, more resilient supply chain for patients across the country."

"The FDA is pleased to support the America First agenda in manufacturing. It's common sense and it increases our national security, " said FDA Commissioner Marty Makary, MD, MPH. "Novartis' investment is a strong step toward making drugs for Americans in America."

Anticipated to open in 2027-2028, the company's flagship manufacturing hub was marked by a formal groundbreaking ceremony at one of the new sites, and photo opportunities to commemorate the occasion.

2025 Marks Year of Significant Investment in US

This groundbreaking is part of a year of significant expansion for Novartis in the US.

-- Regulatory milestones: The company received five U.S. Food and Drug

Administration approvals across oncology, neuroscience, immunology and

renal, underscoring its commitment to bring new innovation to US

patients.

-- Expanded R&D capabilities: The company announced plans to build a new

$1.1B biomedical research hub in San Diego, CA, complementing its

existing US research hub in Cambridge, MA.

-- Coast-to-coast radioligand therapy (RLT) manufacturing: The company

opened a new RLT manufacturing facility in Carlsbad, CA, invested in the

expansion of existing facilities in Indiana and New Jersey, and announced

plans to build new manufacturing facilities in Florida and Texas.

-- End-to-end manufacturing across key medicines: With the flagship

manufacturing hub in North Carolina, the company is on track to

manufacture all its key medicines for US patients in the US.

The US is a priority market for Novartis, and the company is committed to continued growth through investments in manufacturing and R&D to drive forward the ability to deliver breakthrough treatments to patients with speed and broad access, while creating US jobs and helping grow the US economy.

Disclaimer

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release; or regarding potential future revenues from such products; or by discussions of strategy, plans, expectations or intentions, including discussions regarding our continued investment into new R&D capabilities and manufacturing. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. Neither can there be any guarantee that the expected benefits or from the investments described in this press release will be achieved in the expected timeframe, or at all. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis

Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide.

Reimagine medicine with us: Visit us at https://www.novartis.us https://www.novartis.us and connect with us on https://www.linkedin.com/showcase/novartis-us/ LinkedIn US, https://twitter.com/NovartisUS X/Twitter US and https://instagram.com/novartis?igshid=MzRlODBiNWFlZA==__;!!N3hqHg43uw!pjp8z253J5NjaOYrW65UbAAlHeHRdQ-w0m4ezZxEQEl0ptafXN2M99VRIk39pf49PAc8NbK93Pxp3uaSBQkAf8oEnzWXG8Sk$ Instagram.

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Novartis Media Relations

E-mail: media.relations@novartis.com

Novartis Investor Relations

Central investor relations line: +41 61 324 7944

E-mail: investor.relations@novartis.com

A photo accompanying this announcement is available at Figure 1 https://www.globenewswire.com/NewsRoom/AttachmentNg/4d10ffb2-8fb5-4198-b8fd-02503f8143fa

A photo accompanying this announcement is available at Figure 2 https://www.globenewswire.com/NewsRoom/AttachmentNg/575c4b82-4f51-4979-a1fe-71e9e181d8e9

(END) Dow Jones Newswires

December 12, 2025 07:00 ET (12:00 GMT)