Sanofi US News

In the overall trial population, Libtayo reduced risk of death by 32% compared to chemotherapy

Libtayo is the first investigational medicine to show a clinical benefit in advanced basal cell carcinoma following treatment with a hedgehog inhibitor in a prospective trial

* Designation based on positive results from Part A of pivotal Phase 3 trial

BIVV001 is the first investigational factor VIII therapy independent of von Willebrand Factor and has the potential to transform replacement therapy for people with hemophilia A

- New data on investigational brain-penetrant BTK inhibitor tolebrutinib (SAR442168) further support its potential in modulating disabling inflammatory processes within the central nervous system

- Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines

Potential to be the first approved therapeutic for the treatment of Non-responsive Celiac Disease

* Further strengthens core R&D areas of autoimmune and allergic diseases

-Former Director of the Office of New Drugs at the FDA's Center for Drug Evaluation and Research, brings extensive regulatory expertise and experience to Provention-

- Completed commercial-scale drug substance PPQ campaign ahead of schedule, enabling the expected on-time completion of the rolling Biologics License Application (BLA) submission for teplizumab in Q4 2020 -

- Promising vaccine candidate selected by U.S. government’s Operation Warp Speed

- Nirsevimab reduced respiratory syncytial virus (RSV) lower respiratory tract infections by 70 percent and related hospitalizations by 78 percent1

* New alliance will use insights from translational and clinical studies to better identify targets, combinations and potential new indications for current medicines

* Single-dose (300 mg) pre-filled pen provides additional administration option to adults and adolescents who are prescribed Dupixent

-One Course of Teplizumab Now Shown to Delay Insulin-Dependent T1D by a Median of Approximately Three Years Compared to Placebo-

- Preclinical data show anti-tumor activity in Sanofi's investigational compounds, including an oral selective estrogen receptor degrader (SERD) and an anti-CEACAM5 antibody-drug conjugate

* Additional donation of factor therapy fulfills 2014 pledge to donate up to an unprecedented 1 billion IUs for humanitarian use

Sarclisa added to carfilzomib and dexamethasone (Sarclisa combination) reduced risk of disease progression or death by 47% versus standard of care carfilzomib and dexamethasone (Kd) alone

Across all groups combined, complete responses (CR) are now 16%; in the metastatic group with the longest follow-up, CRs are 20% representing a 200% increase over two years

- In the pivotal trial, more than twice as many children achieved clear or almost clear skin and more than four times achieved itch reduction with Dupixent plus topical corticosteroids (TCS) compared to TCS alone

- Nancy Wysenski, a Seasoned Pharmaceutical Executive with Rare Disease and Commercialization Experience, Appointed as a New Director -

-- The preclinical prototype vaccine is well-tolerated and provides strong protection against coxsackievirus B infections and diabetes in relevant animal models

Sutimlimab targets C1-activated hemolysis in cold agglutinin disease (CAD)

- Emerging data demonstrate commitment to advancing cancer care, including two fully in-house investigational compounds: a potential best-in-class oral SERD for breast cancer and a first-in-class anti-CEACAM5 antibody-drug conjugate for non-small cell lung cancer

- IKEMA trial results released early based on recommendation of an Independent Data Monitoring Committee

- Company on Track to Complete Submission of Rolling Biologics License Application for Teplizumab in Q4 2020 -

Objective responses seen in 29% of patients with locally advanced basal cell carcinoma (BCC)

- Libtayo decreased the risk of death by 32.4% compared to chemotherapy

• Independent Data Monitoring Committee recommended continuing ongoing Phase 3 trial only in the more advanced “critical” group with Kevzara higher-dose versus placebo and discontinuing less advanced “severe” group

Latest innovation in quadrivalent meningococcal vaccination designed for use in persons 2 years of age and older in the U.S.

Primary and secondary objectives were met with 85% or greater relative reduction achieved in the number of new gadolinium-enhancing T1 and new or enlarging T2 hyperintense lesions

- 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