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Investor Presentaiton

14 Entyvio Any biosimilar that seeks to launch prior to 2032 would need to address vedolizumab potential infringement and/or the validity of all relevant patents Takeda Takeda has granted patents that cover various aspects of Entyvio, including formulation, dosing regimens and process for manufacturing. These patents are expected to expire in 2032 in the U.S. Potential scenario in the U.S. should patents be challenged in biosimilar litigation 2023 2024 2025 2026 2027 Clinical development timeline Regulatory Biosimilar clinical trials expected to take 3-4+ years review (~1 year) Legal proceedings Pre-litigation process 2028 2029 2030 2031 2032 Entyvio is only approved in IBD indications, for which clinical trials are typically longer and more challenging to complete than other auto-immune diseases which we have recently observed biosimilar manufacturers target In general, biosimilar litigation proceedings in the U.S. may take 3-5 years In the U.S., the biosimilar litigation process is triggered by FDA acceptance of a relevant aBLA Competitive Intelligence suggests Ph1 activity starting with biosimilar companies in China and Iran. However, no vedolizumab biosimilar Phase 1 clinical trial starts targeting the U.S., EU, or Japan markets has been publicly disclosed so far.
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