Sanofi: Press Releases, Monday, December 9, 2019
Pipeline Movements Since Q3 2019
| Additions & Moves | Removals from Sanofi portfolio | |||
| Registration | ||||
| Phase 3 | BIVV001(**)(1) rFVIIIFc – vWF – XTEN(2) Hemophilia A | |||
| Phase 2 | SAR439859 SERD Metastatic Breast Cancer | |||
| Phase 1 | ||||
- Developed in collaboration with SOBI
- Recombinant Coagulation Factor VIII Fc – von Willebrand Factor – XTEN Fusion protein Developed in collaboration with Denali(**) Partnered and/or in collaboration – Sanofi may have limited or shared rights on some of these products
Appendix 2: Expected R&D milestones
| Products | Expected milestones | Timing |
| Sarclisa® (isatuximab) | Pivotal trial read-out in 2L Relapsed-Refractory Multiple Myeloma (IKEMA) | Q1 2020 |
| olipudase alfa | Pivotal trial read-out in Acid Sphingomyelinase Deficiency(3) | Q1 2020 |
| SAR442168(1)(**) (BTKi) | Proof of concept study read-out in Relapsing Multiple Sclerosis | Q1 2020 |
| cemiplimab | Pivotal trial read-out in 2L Basal Cell Carcinoma | H1 2020 |
| Sarclisa® (isatuximab) | U.S./ EU regulatory decisions in 3L Relapsed-Refractory Multiple Myeloma | Q2 2020 |
| MenQuadfi™ | U.S. regulatory decision for ≥ 2 year old age group | Q2 2020 |
| Fluzone® QIV HD | EU regulatory decision for ≥ 65-years old age group | Q2 2020 |
| avalglucosidase alfa | Pivotal trial read-out in Late Onset Pompe Disease | Q2 2020 |
| SAR440340(**)(2) (anti-IL33 mAb) | Proof of concept study read-out in Atopic Dermatitis | Q3 2020 |
- Developed in collaboration with Principia
- Developed in collaboration with Regeneron
- Also known as Niemann Pick type B
(**) Partnered and/or in collaboration – Sanofi may have limited or shared rights on some of these products
QIV: Quadrivalent Influenza Vaccine; HD: High-Dose;