Novartis Pharma AG: Sandoz strengthens pipeline by entering into agreement for biosimilar bevacizumab, a key oncology medicine

• Sandoz enters into commercialization agreement for biosimilar bevacizumab with Bio-Thera Solutions, Ltd., for treatment of multiple types of cancers^1,2
• Sandoz is committed to building on its leading generic and biosimilar oncology portfolio to further expand patient access, while contributing to sustainability of healthcare systems

Basel, September 8, 2021 - Sandoz, a Novartis division, today announced that it has entered into a commercialization agreement with Bio-Thera Solutions, Ltd. for biosimilar bevacizumab (BAT1706). Bevacizumab is a recombinant humanized monoclonal IgG1 antibody that targets vascular endothelial growth factor (VEGF), a key mediator of angiogenesis in cancer, and is used in combination with other treatments^1,2.

Bio-Thera Solutions, Ltd. will maintain responsibility for development and manufacturing, Sandoz will have the right to commercialize the medicine upon approval in the US, Europe**, Canada and selected other countries. According to the terms of the agreement, Bio-Thera Solutions, Ltd. will receive an upfront and milestone payments and is entitled to receive profit share payments in the partnered territory.

This agreement builds on Sandoz's leading off-patent oncology portfolio, which comprises four marketed oncology biosimilars and over 50 generic medicines worldwide^3,4. We see external collaborations as complementary to our internal programs, with an appropriate strategic balance enabling us to drive patient access by delivering portfolio breadth, balancing risks and costs and positioning us to play a leading role in the future biosimilar market.

Bio-Thera Solutions, Ltd. is a biopharmaceutical company located in Guangzhou, China, and dedicated to research and development into novel therapeutics, as well as biosimilars to treat a range of cancer and autoimmune diseases.

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 biosimilar bevacizumab, or regarding the commercialiation agreement described in this press release, or regarding potential future revenues from biosimilar bevacizumab. 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 biosimilar bevacizumab 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, biosimilar bevacizumab will be approved for all indications included in the reference product's label. Nor can there be any guarantee that biosimilar bevacizumab will be commercially successful in the future. Neither can there be any guarantee that the commercialization agreement will achieve any or all of the anticipated outcomes for Novartis, or in any particular time frame. In particular, our expectations regarding biosimilar bevacizumab and the commercialization agreement 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 biosimilar versions of bevacizumab; 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 all major therapeutic areas, accounted for 2020 sales of USD 9.6 billion.

Sandoz on social media:
LinkedIn: https://www.linkedin.com/company/sandoz/ (https://www.linkedin.com/company/sandoz/)
Twitter: https://twitter.com/sandoz_global (https://twitter.com/sandoz_global)
Facebook: https://www.facebook.com/sandozglobal/ (https://www.facebook.com/sandozglobal/)
Instagram: https://www.instagram.com/sandozglobal (https://www.instagram.com/sandozglobal)

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

References

1. Avastin, INN-bevacizumab - European Medicines Agency. Summary of Product Characteristics. Available from: https://www.ema.europa.eu/en/documents/product-information/avastin-epar-product-information_en.pdf (https://www.ema.europa.eu/en/documents/product-information/avastin-epar-product-information_en.pdf). [Last accessed: August 2021].
2. European Medicines Agency. Summary of Product Characteristics. Available from https://www.ema.europa.eu/en/documents/overview/equidacent-epar-medicine-overview_en.pdf (https://www.ema.europa.eu/en/documents/overview/equidacent-epar-medicine-overview_en.pdf). [Last accessed: August 2021].
3. Sandoz data on file.
4. IQVIA through 2020, definition excludes biosimilars

*Avastin is a registered trademark of Genentech, Inc.

** countries geographically in Europe excluding Russia

# # #

Sandoz Global Communications

Chris Lewis Sandoz Global Communications [phone] (mobile) [e-mail] (mailto:[e-mail]) (mailto:[e-mail])
Michelle Bauman Sandoz Global Communications [phone] (mobile) [e-mail] (mailto:[e-mail])

Novartis Media Relations
E-mail: [e-mail] (mailto:[e-mail])


Richard Jarvis
Novartis Strategy & Financial Communications
[phone]
[e-mail] (mailto:[e-mail])

Novartis Investor Relations
Central investor relations line: [phone]
E-mail: [e-mail] (mailto:[e-mail])

Central		North America
Samir Shah	[phone]	Sloan Simpson	[phone]
Thomas Hungerbuehler Isabella Zinck	[phone] [phone]