Sanofi US News

* First biologic medicine for adults with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP)

Results from the NIH-Sponsored "At-Risk" Study Published in The New England Journal of Medicine and Presented at the American Diabetes Association Annual Meeting

News Summary: * Isatuximab, an investigational anti-CD38 monoclonal antibody, added to pomalidomide and dexamethasone prolonged progression free survival by 5 months compared to pomalidomide and dexamethasone alone (11.53 vs. 6.47 months, p=0.001, HR 0.596) * Overall response rate significantly greater with isatuximab combination therapy compared to pomalidomide and dexamethasone (60% vs. 35%, p<0.0001) * First positive randomized Phase 3 trial to evaluate an antibody in combination with pomalidomide and dexamethasone presented at this year’s ASCO annual meeting * European Medicines Agency accepted for review the Marketing Authorization Application for isatuximab

- Pivotal Phase 3 data evaluated isatuximab (anti-CD38) in combination with pomalidomide/dexamethasone in prolonging progression-free survival in relapsed/refractory multiple myeloma

* New data at ASCO include more than double the patients previously reported; median overall survival still not reached with a median follow-up of up to 17 months

PROTECT Pivotal Phase 3 Clinical Study Initiated in Patients with Recent Onset Type 1 Diabetes

* Only biologic approved in the EU for severe asthma with type 2 inflammation, as characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO)

* Praluent is the first PCSK9 inhibitor that has shown a meaningful reduction in death from any cause

- Top-line Data Anticipated in the Fourth Quarter of 2019 -

* Sanofi continues its commitment to helping reduce cost burden for people living with diabetes with first-ever insulin savings program

Pivotal Study to Evaluate Potential of Anti-CD3 Monoclonal Antibody to Intercept Type 1 Diabetes

Strengthens Leadership Team with Appointment of Douglas Jacobstein, M.D. as V.P. of Clinical Development and Alex Rabiee as V.P. of Business Development

Dr. Bluestone is a World-renowned Expert and Academic Leader in Immune Tolerance Research

Plan to Initiate PROTECT Study for PRV-031 (teplizumab) in T1D Patients in Q2

* Only therapy that targets the IL-4/IL-13 pathway, a key driver of the allergic or type 2 inflammation that underlies atopic dermatitis

* Soliqua 100/33 now approved as an add-on to diet and exercise for adults with type 2 diabetes

Praluent® (alirocumab) continues to be available in the U.S.