Sandoz strengthens pipeline expansion through partnership to develop and manufacture multiple biosimilars

• Sandoz and Just – Evotec Biologics announce partnership to develop and manufacture multiple biosimilars with an option for expansion

• Sandoz gains access to proprietary AI-driven technology platform that delivers fully integrated drug substance development and continuous manufacturing

• Partnership supports Sandoz pipeline expansion to 24 biosimilar assets, provides opportunity to enhance integrated development and manufacturing network

Basel, May 9, 2023 — Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announced a multi-year partnership with Just – Evotec Biologics, the Seattle-based subsidiary of Evotec SE. The agreement covers the development and manufacture of multiple biosimilar medicines with an option for expansion and is the most recent step towards strengthening the Sandoz foundation as a stand-alone off-patent medicines company.

Access to Just – Evotec Biologics’ highly efficient drug substance development platform and manufacturing technology complements Sandoz capabilities, supporting expansion of the current pipeline from 15+ to 24 assets and the continued development of its early-stage biosimilar pipeline.

“This strategic partnership is founded on a strong shared sense of purpose and commitment to use disruptive technology with lower operational costs to deliver high-quality biosimilars at scale to patients around the world,” says Sandoz CEO Richard Saynor.

“It provides us with additional capabilities to support the strategic expansion of our pipeline with new assets and to begin immediately transitioning our early biosimilar pipeline – ensuring continuity in development and manufacturing while Sandoz finalizes its planned separation from Novartis. Development of the biosimilars will ramp-up over the coming 12-18 months.”

Just – Evotec Biologics has developed an optimized proprietary ecosystem for cost-efficient, state-of-the-art drug development and manufacturing. This includes an advanced continuous manufacturing process, a relatively new, but already well-established technology which delivers enhanced quality and productivity in biologics production. Under the terms of the agreement, Sandoz has optionality to use of this technology.

Sandoz is a pioneer and market leader in biosimilars and this partnership with Just – Evotec Biologics comes shortly after the company announced increased investments in its Holzkirchen site in Germany to create a core Biopharma Technical Development hub supporting future biosimilar growth. In addition, Sandoz recently signed a Memorandum of Understanding to build a new biologics production plant in Slovenia – an expected investment of at least USD 400 million to support increasing global demand for biosimilar medicines. Work is set to begin this year, with full operations provisionally planned for late 2026.

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.

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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.

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