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

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

* 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

* $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.

* 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

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

* 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

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

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

* $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)

- 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

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

* 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

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

- 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

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.

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

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

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

* 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

- 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

- 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

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

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

- 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

- 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

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

* First biologic medicine for adults with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP)

- Pivotal Phase 3 data evaluated isatuximab (anti-CD38) in combination with pomalidomide/dexamethasone in prolonging progression-free survival in relapsed/refractory multiple myeloma

* 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

* Sanofi continues its commitment to helping reduce cost burden for people living with diabetes with first-ever insulin savings program

* 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

* 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

- 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

* 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

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

-- Only biologic approved for both moderate and severe asthma patients with eosinophilic phenotype

- Dupixent significantly reduced nasal polyp size, nasal congestion severity, and need for systemic corticosteroids and/or surgery

* Libtayo is the third anti-PD-1 approved in the U.S.

* FDA also recently approved Praluent label update for some patients currently requiring LDL apheresis therapy

- First therapeutic approved for the treatment of aTTP, a rare blood-clotting disorder

Nearly 70 million doses to be manufactured this season

- Company invests €66 million in Chengdu, Sichuan province, China

- Toujeo (insulin glargine injection 300 Units/mL) met primary endpoint in lowering blood sugar levels and was non-inferior to insulin degludec in adults with type 2 diabetes not previously on insulin

-- Patients treated with cemiplimab experienced robust anti-tumor effects

* In steroid-sparing VENTURE trial, Dupixent-treated patients substantially reduced use of oral corticosteroids, yet had fewer exacerbations and improved lung function compared to placebo.

* U.S. regulatory submission for patients ages 12-17 planned for third quarter 2018

-- Agreement provides Praluent at lower net price and enables streamlined patient access based on physician attestation

- If approved, health care professionals will be able to use the same 0.5 mL dose of Fluzone Quadrivalent vaccine with all patients ages 6 months and older for whom flu vaccination is recommended - which may provide more flexibility and convenience to immunizers.

* Max SoloStar holds more insulin than any other long-acting insulin pen

* Precision medicine approach will focus efforts on high-risk patients, such as those who have had heart attacks or unstable angina and cannot reduce their LDL-C below 100 mg/dL despite maximally-tolerated statins

* ODYSSEY OUTCOMES trial met its primary endpoint, demonstrating that high-risk patients who added Praluent® (alirocumab) Injection to maximally-tolerated statins experienced significantly fewer major adverse cardiovascular events compared to those on maximally-tolerated statins alone