Sanofi US News

- Companies to negotiate a collaboration on the development of a breakthrough COVID-19 self-test solution based on Luminostics’ proprietary technology.

- Rolling BLA Submission Initiated Under Breakthrough Therapy Designation

Companies to combine innovative technologies to develop an adjuvanted COVID-19 vaccine

The award showcases innovative game-changers who are setting the standard for pharmaceutical facilities of the future

- Detailed data to be presented at the Revolutionizing Atopic Dermatitis Conference show adding Dupixent to topical corticosteroids improved skin clearance; average overall disease improved by approximately 80%

* The two companies will jointly investigate multiple candidates with the goal of advancing an efficacious and safe SARS-CoV-2 vaccine into clinical development

- PROTECT Study Randomization to be Paused Temporarily in Response to the Ongoing Public Health Crisis

* U.S. Phase 2/3 trial initiated and will begin enrolling patients immediately

- Expect to Complete Submission of a BLA for PRV-031 (Teplizumab) in Q4 2020

-PRV-3279 Inhibited the Function of B Cells, Durably and Without Depletion-

* Sarclisa in combination with pomalidomide and dexamethasone (pom-dex) significantly reduced the risk of disease progression or death by 40% compared to pom-dex alone in a pivotal trial

- Work with Biomedical Advanced Research and Development Authority (BARDA) will utilize Sanofi's well-established recombinant technology platform to expedite a potential COVID-19 vaccine

JDRF T1D Fund Study Estimates 2.3 Million People at Risk Globally to Develop Stage 3 T1D, Which Already Affects 18 Million People Globally

- Acid sphingomyelinase deficiency (ASMD) is a rare, progressive and potentially life-threatening disease for which no treatments are approved

If approved, Dupixent would be the first biologic medicine available in the U.S. for these children

* Synthorx, Inc. is now a fully owned subsidiary of Sanofi

Expects to Complete Submission of a BLA for PRV-031 (Teplizumab) in Q4 2020

- U.S.-based, state of the art facilities to be established for sustainable production of adjuvanted recombinant vaccine for use in the event of a pandemic

- Sutimlimab, an investigational targeted C1s inhibitor, met its primary efficacy endpoint in Phase 3 trial for patients with cold agglutinin disease (CAD)

*Oncology: New data from investigational isatuximab pivotal study for the treatment of relapsed/refractory multiple myeloma

- PRV-031 (teplizumab) Granted Breakthrough Therapy and PRIME Designations -

* Will be available in fall 2020, in time for the 2020-2021 flu season

-Study Did Not Achieve Primary Endpoint Due to High Placebo Effect-

- One of the first digital manufacturing facilities in the world to use continuous, intensified biologics production technology

Add-on payment to provide additional Medicare reimbursement for Medicare patients prescribed Cablivi in eligible hospital inpatient settings

- CARD is a treatment sequencing trial investigating the efficacy and safety of Jevtana versus abiraterone or enzalutamide after disease progression following initial androgen receptor-targeted agent therapy and docetaxel

- T1D Fund Executive Chairman and Former Bain Capital Managing Director Brings Extensive Financial Expertise and Deep Knowledge of Therapeutics Landscape -

- FDA Meeting Expected in Q4 2019 and BLA Submission for PRV-031 (teplizumab) Targeted for Q4 2020 -

Understand AD program brings together a team of experts to help a teen with severe atopic dermatitis (AD) and his parents navigate the disease

- Collaboration aims to provide a connected device experience for millions of people living with diabetes using insulin

Court rules in favor of Sanofi and Regeneron in ongoing Praluent® (alirocumab) patent litigation

- Appoints Dr. Sherron Kell as SVP of Clinical Development and Program Lead for PRV-031 (Teplizumab) -

-Bispecific Diabody Designed to Intercept B-Cell Mediated Autoimmune Diseases-

U.S. FDA submission for children planned for 4Q 2019

PRV-031 Granted Breakthrough Therapy Designation for the Delay or Prevention of Clinical Type 1 Diabetes in At-Risk Individuals

* 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.

* This is the latest step by the companies to help make Praluent more accessible and affordable for appropriate patients

- First medicine approved in the U.S. specifically for the treatment of aTTP, a rare blood-clotting disorder

Provention is currently developing PRV-101 as a polyvalent vaccine for acute coxsackie virus infection and to potentially prevent the onset of T1D

- The 0.5 mL dose is now approved for use in children 6 months through 35 months of age

* First and only vaccine approved in the U.S. for repeat vaccination 8 years or more after the first vaccination to help protect against tetanus, diphtheria and pertussis, offering flexibility for health care providers to help manage their immunization schedules(2)

-HERCULES Phase 3 trial met its primary endpoint, demonstrating that treatment with Cablivi resulted in a significantly faster time to platelet count response in patients with acquired thrombotic thrombocytopenic purpura (aTTP) when administered in conjunction with plasma exchange and immunosuppression

Provention is currently developing PRV-101 as a vaccine for acute coxsackie infection and to potentially prevent the onset of T1D

* Mortality risk reduction greater in patients treated for at least 3 years or those with baseline LDL-C levels of at least 100 mg/dL

Conference Call and Live Audio Webcast Scheduled for Today at 8:30 a.m., ET

* Praluent significantly reduced major adverse cardiovascular events by 15% (p<0.001)