Sanofi US News

Dupixent significantly improved skin clearance and reduced overall disease severity and itch in a Pivotal trial that met all primary and secondary endpoints

Sarclisa combination therapy is first to demonstrate superiority to standard of care lenalidomide, bortezomib and dexamethasone (RVd) in a Phase 3 trial

Dupixent significantly reduced severe asthma attacks and improved lung function and asthma control in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma

* Regardless of gender or sexual orientation, employees welcoming a child into their family receive equal amount of paid time off

Andrew Drechsler to Retire as Chief Financial Officer in December

PRV-101 was well tolerated and elicited high titers of virus-neutralizing antibodies in a dose-dependent fashion in healthy volunteers

Dupixent 300 mg weekly significantly improved the ability to swallow and reduced eosinophils in the esophagus compared to placebo, reinforcing positive results from first Phase 3 trial

Pivotal trial met primary and all key secondary endpoints

Dupixent is the only biologic medicine to improve lung function in children aged 6 to 11 years in a randomized Phase 3 trial, supporting potential as a best-in-class option

First study to investigate the safety and immunogenicity of both vaccines when co-administered compared to each vaccine administered separately in adults aged 65 years and older

Presentations focused on respiratory syncytial virus, meningococcal disease, and influenza

*Phase 3 trial met its primary and key secondary endpoints

Data collection completed for PROTECT Pharmacokinetic/Pharmacodynamic (PK/PD) substudy

Dupixent rapidly improved symptoms after first dose, improving itch in one week and skin clearance in two weeks

Approval is based on positive Phase 3 data demonstrating improvements in key disease burden measures and establishing its safety profile

Libtayo combined with chemotherapy increased median overall survival from 13 to 22 months, leading to a 29% reduction in the risk of death

Fifth disease that Dupixent has demonstrated positive pivotal results

Designation is the first step in a new MHRA initiative to accelerate the development and access to innovative medicines in the UK post-Brexit

Previously reported pharmacokinetic (PK) drug product comparability considerations remain outstanding

New research from first-in-class marketed and investigational therapies in hemophilia, immune thrombocytopenia and acquired thrombotic thrombocytopenic purpura will be presented

* Study also shows more people on Soliqua 100/33 had improved blood sugar control without weight gain and without low blood sugar events (hypoglycemia) in first head-to-head comparison with premixed insulin

- 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 -