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-