Sanofi US News

- Respiratory syncytial virus (RSV) is the leading cause of hospitalization in all infants^1,2

* $425 million investment in Sanofi's Swiftwater, PA facility expands production of Fluzone® High-Dose Quadrivalent for people 65 and older in the U.S.

Phase 3 data from the CADENZA study met the primary composite endpoint with statistical significance; secondary endpoint data were clinically meaningful

* Sanofi partnering with the Breast International Group (BIG), the European Organization for Research and Treatment of Cancer (EORTC) and Alliance Foundation Trials (AFT), which are world-leading academic groups delivering practice-changing breast cancer clinical research

* This combination vaccine may simplify execution and reduce shots needed to complete CDC's recommended child and adolescent immunization schedule

If approved, teplizumab will be the first disease-modifying therapy in T1D

-- FDA Advisory Committee to Review Biologics License Application for PRV-031 for the Delay of Clinical Type 1 Diabetes --

Early clinical data for investigational oral selective estrogen receptor (SERD), amcenestrant, show potential to become a new endocrine backbone therapy in ER+ HER2- breast cancer

- Amcenestrant, an investigational oral selective estrogen receptor degrader (SERD), achieved an objective response rate of 34% and a clinical benefit rate of 74% in Phase 1 study (AMEERA-1) in combination with palbociclib

- Dupixent is the only biologic medicine to improve lung function in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma in a randomized Phase 3 trial, with potential to be best-in-class treatment for these patients

Libtayo is the first immunotherapy to demonstrate an improvement in overall survival in advanced cervical cancer, as well as progression-free survival and objective response rate, compared to chemotherapy

* Projects led by collaborating researchers from the two organizations will focus on autoimmune diseases and inflammatory conditions

- Sanofi is the only company to leverage its manufacturing capacity and expertise to support three different COVID-19 vaccines to support the global supply of vaccines and help address the pandemic

Respiratory Syncytial Virus (RSV) is the leading cause of hospitalization in all infants.1-5

Nearly 30 data presentations at AAD and ESPD across clinical and real-world settings, including the impact of Dupixent on disease measures in uncontrolled moderate-to-severe atopic dermatitis

- Conference call and webcast to be held today at 5:00 p.m. Eastern Time -

Data from the pivotal Phase 3 CARDINAL study demonstrated sutimlimab inhibited C1-activated hemolysis (abnormal destruction of healthy red blood cells) within one week of treatment and had a sustained treatment effect over the course of the study

* Launch of a new and more impactful global corporate social responsibility strategy

- Sarclisa regimen reduced risk of disease progression or death by 45% compared to standard of care in patients who had relapsed after one to three prior therapies

Libtayo is the first immunotherapy to demonstrate improved overall survival in patients with cervical cancer, reducing the risk of death by 31% compared to chemotherapy

Fabrazyme is the only FDA-approved enzyme replacement therapy for Fabry disease with long-term efficacy and safety data

Submission supported by data demonstrating Dupixent significantly reduced severe asthma attacks and is the only biologic to improve lung function in children aged 6 to 11 years with asthma in a randomized Phase 3 trial, while also further adding to the well-established safety profile of Dupixent

-One course of teplizumab delayed insulin dependence by approximately three years and improved beta cell function in at-risk (Stage 2) type 1 diabetes patients-

-U.S. Food and Drug Administration (FDA) filing of a Biologics License Application (BLA) and Priority Review for teplizumab for the delay or prevention of clinical type 1 diabetes in at-risk individuals; PDUFA goal date of July 2, 2021-

Libtayo was superior in extending overall survival compared to chemotherapy in a pivotal trial that allowed for certain disease characteristics frequently underrepresented in advanced NSCLC trials

- Company also Announces Presentation at the 2021 SVB Leerink Global Healthcare Conference -

Efanesoctocog alfa, previously known as BIVV001, is an investigational factor VIII replacement therapy that has the potential to transform therapy and provide high sustained factor activity levels for people with hemophilia A

- Provention Bio to receive $6 million upfront payment; up to $11.5 million in research, development and manufacturing funding; and up to $172 million in potential development, regulatory and commercial milestone payments -

Following Priority Review Libtayo receives full approval in locally advanced basal cell carcinoma (BCC) and accelerated approval in metastatic BCC

-- Improvements were noted across key disease measures in certain patients with asthma, atopic dermatitis, eosinophilic esophagitis and chronic rhinosinusitis with nasal polyposis

- PRV-3279 Murine Surrogate Inhibited the Production of Anti-adenoviral Vector Antibodies in a Mouse Model for Pompe Disease -

-FDA sets PDUFA goal date of July 2, 2021-

- Potential to be the first vaccine for the prevention of coxsackievirus B, a presumed infectious trigger in the development of type 1 diabetes and celiac disease -

Phase 3 trial initiated to evaluate rilzabrutinib, the potential first BTK inhibitor (Bruton’s tyrosine kinase inhibitor) for the treatment of immune thrombocytopenia

The FDA decision date for avalglucosidase alfa, an investigational enzyme replacement therapy, is set for May 18, 2021

Complete Response Letter refers to deficiencies from a pre-license inspection of a third-party manufacturing facility

Oncology: Results from an interim analysis of Sarclisa® (isatuximab-irfc) in patients with relapsed multiple myeloma, including an evaluation of depth of response, will be shared in an oral presentation

- Completed rolling submission of the Biologics License Application (BLA) for teplizumab in the delay or prevention of clinical type 1 diabetes (T1D) in at-risk individuals -

* Award recognizes innovative accomplishments in facility design, construction, and operation that are setting the standard for pharmaceutical facilities of the future

- Submission of chemistry, manufacturing and controls (CMC) and administrative information modules represent completion of the Company's BLA submission for teplizumab -

Results of two clinical studies in adults and children with acid sphingomyelinase deficiency (ASMD) presented at the American Society of Human Genetics 2020 Virtual Meeting

- First Phase 3 trial in eosinophilic esophagitis (EoE) to show a biologic medicine significantly improved structural and histologic measures, while rapidly improving ability to swallow in patients 12 years and older

* $1 million in research funding to support PD GENEration, a first-of-its-kind national study offering free genetic testing and counseling for people with Parkinson's disease (PD)

Data in children aged 6-11 further suggest Dupixent has potential to be best-in-class treatment option

- Healthcare professional and patient campaigns focus on screening for early-stage T1D-

- Expect to complete filing of the rolling Biologics License Application (BLA) submission for teplizumab in Q4 2020 -

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)