Sandoz to exclusively commercialize six products in the US, reinforcing global leadership position in off-patent medicines

• Agreement offers exclusive rights to commercialize six products in key areas of anti-infectives and oncology.

• Products from Adalvo slated for near- to mid-term launches, with four out of six anticipated to be first-to-market

• Sandoz continues to expand patient access to much-needed medications, drive patient savings, and ensure the sustainability of healthcare systems worldwide

Basel, May 4, 2023 – Sandoz, a global leader in generic pharmaceuticals and biosimilars, today announced that it has signed a distribution and collaboration agreement with Adalvo for exclusive Sandoz rights to commercialize six products in the US across key therapeutic areas, including antifungal/antibiotic, oncology and pulmonary.

“Sandoz is putting patients first by securing the rights to bring more affordable, equally effective treatments for a range of disorders that collectively affect millions of people in the US every year,” said Keren Haruvi, President, Sandoz Inc. “This agreement also helps advance our ambition to be the world’s largest and most valued generics company.”

These products, which are slated for near- to mid-term launches beginning in 2024, have a total addressable market size of approximately USD 3 bn, further advancing the Sandoz product pipeline in the key US generics market. The agreement also demonstrates the unwavering Sandoz commitment to pioneering patient access to critical medicines in areas of greatest unmet need.

In addition to building out the Sandoz US offering in these key areas, the antibiotic products would also underpin the Sandoz strategy of combatting the global spread of antimicrobial resistance (AMR) by driving responsible access to a broad range of appropriate treatments.

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. 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. Neither can there be any guarantee that, if approved, such generic or biosimilar products will be approved for all indications included in the reference product’s label. Nor can there be any guarantee that such products will be commercially successful in the future. 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; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional generic or biosimilar versions of such products; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling its products; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; 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 Sandoz
Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical needs. Our ambition is to be the world’s leading and most valued generics company. Our broad portfolio of high-quality medicines, covering major therapeutic areas, accounted for 2022 sales of USD 9.2 billion.

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CEO Richard Saynor on LinkedIn: https://www.linkedin.com/in/richard-saynor/

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