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DewDiligence

03/16/23 8:24 PM

#5462 RE: DewDiligence #5021

Xtandi phase-3 shows statsig-superior MFS* both as an addend to Lupron (compared to Lupron alone) and as monotherapy compared to Lupron in non-metastatic HSPC patients at high-risk for disease recurrence:

https://www.pfizer.com/news/press-release/press-release-detail/phase-3-study-shows-xtandir-enzalutamide-plus-leuprolide

The (secondary endpoint) OS data are not yet mature, but are trending positively for Xtandi + Lupron vs Lupron alone. The full dataset will be presented at an unspecified medical conference.

PFE booked $1.2B in Xtandi-alliance revenue in 2022 pursuant to its worldwide collaboration with Astellas that splits US profits 50/50 and pays PFE royalties on ex-US sales. Xtandi goes off-patent in the US in 2027.

*Metastasis-free survival (similar to PFS).