Sanofi
ENXTPA:SAN
88.65
+ 0.63€ (0.72%)
88.65
+ 0.63€ (0.72%)
Real-time: 03/22/2024 17:30

About Sanofi

Sanofi, a global healthcare company, engages in the research, development, manufacture and marketing of therapeutic solutions. Sanofi share price history

Segments

The company operates through three operating segments: Pharmaceuticals, Vaccines, and Consumer Healthcare.

The Pharmaceuticals segment comprises, for all geographical territories, the commercial operations of the following global franchises: Specialty Care (Dupixent, Neurology & Immunology, Rare Diseases, Oncology, and Rare Blood Disorders) and General Medicines (Core and Non-Core Assets), together with research, development and production activities dedicated to the Pharmaceuticals segment. This segment also includes associates whose activities are related to pharmaceuticals.

The Vaccines segment comprises, for all geographical territories, the commercial operations of Vaccines, together with research, development and production activities dedicated to vaccines.

The Consumer Healthcare segment comprises, for all geographical territories, the commercial operations for Sanofi’s Consumer Healthcare products, together with research, development and production activities dedicated to those products. Sanofi share price history

Main Pharmaceutical Products

Specialty Care

Dupixent

Dupixent (dupilumab) is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. Dupilumab is jointly developed by Sanofi and Regeneron under a global collaboration agreement. As of December 31, 2022, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. The dupilumab development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase III trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple inflammatory diseases, such as atopic dermatitis (AD), asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis and prurigo nodularis. Dupixent comes in either a pre-filled syringe for use in a clinic or at home by self-administration as a subcutaneous injection or in a pre-filled pen for at-home administration, providing patients with a more convenient option. Dupixent is available in all major markets, including the U.S. (since April 2017), most European Union countries (the first launch was in Germany in December 2017), and Japan (since April 2018).

Atopic Dermatitis

Moderate-to-severe AD, a form of eczema and a chronic inflammatory disease, is characterized by rashes that sometimes cover much of the body and can include intense, persistent itching and skin dryness, cracking, redness, crusting and oozing. 85 to 90 percent of patients first develop symptoms before 5 years of age, which can often continue through adulthood.

In 2014, the FDA granted Dupixent Breakthrough Therapy designation and after a Priority Review evaluation, in March 2017 it granted Dupixent marketing authorization for the treatment of adults with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. In 2016, the FDA granted Dupixent Breakthrough Therapy designation for adolescent patients aged 12 to 17 years and in March 2019, the FDA extended the marketing authorization for this age group.

In 2016, the FDA granted Breakthrough Therapy designation for Dupixent for the treatment of severe AD in children aged 6 months to 11 years. On May 26, 2020, Dupixent was approved as the first biologic medicine for children aged 6 to 11 years with moderate-to-severe AD. On June 7, 2022, after accepting Dupixent for Priority Review in February, the FDA approved Dupixent for children aged 6 months to 5 years with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable, making Dupixent the first biologic medicine to significantly reduce signs and symptoms in children as young as 6 months.

The European Commission (EC) approved Dupixent in September 2017 for use in adults with moderate-to-severe AD who are candidates for systemic therapy, and extended the marketing authorization in August 2019 to include adolescents aged 12 to 17 years. On November 30, 2020, the EC extended the marketing authorization to children aged 6 to 11 years with severe AD and on June 28, 2021, the Dupixent Summary of Product Characteristics (SmPC) was updated with long-term data for up to 3 years, reinforcing the product's well-established safety profile in adults with moderate-to-severe AD. On January 27, 2023, the CHMP adopted a positive opinion for Dupixent recommending expanded approval in the EU to treat severe atopic dermatitis in children 6 months to 5 years old who are candidates for systemic therapy. The EC is expected to announce a final decision on the Dupixent application in the coming months.

On June 19, 2020, the National Medical Products Administration (NMPA) in China approved Dupixent for adults for the treatment of moderate-to-severe AD after identifying dupilumab as an overseas medicine regarded as urgently needed in clinical practice, leading to an expedited review and approval process. On December 28, 2020, the National Healthcare Security Administration (NHSA) officially announced the results of the 2020 National Reimbursement Drug List (NRDL) negotiations, with Dupixent 300 mg included in the updated NRDL effective March 1, 2021. Dupixent was approved in China in September 2021 for adolescents aged 12-17 years with moderate-to-severe atopic dermatitis. The indication for children aged 6 years and over, along with the adolescent and adult AD indications, was included in the current NRDL reimbursement scope, which was reviewed during the Dupixent NRDL renewal in 2022 in accordance with the two-year cycle for the China access process.

In March 2022, at the annual meeting of the American Academy of Dermatology (AAD 2022), Sanofi presented results from a long-term efficacy open-label study where dupilumab demonstrated robust and sustained efficacy with progressive improvement of AD signs and symptoms in adults with moderate-to-severe AD who completed up to 4 years of treatment: the longest duration of data for any biologic medicine in this disease. Additionally, the long-term safety data from a 52-week open-label extension trial in 6 months to 5 years reinforces the well-established safety profile of Dupixent observed across all other approved age groups. This data built on the existing wealth of evidence supporting the selective way Dupixent inhibits IL4/IL-13 pathways, both key and central drivers of the type 2 inflammation, thereby significantly improving itch and skin lesions and other important measures that impact a patient’s quality of life.

Asthma

Dupixent was granted marketing authorization by the FDA in October 2018 as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma. In May 2019, the European Commission approved Dupixent for use as an add-on maintenance treatment in severe asthma patients aged 12 years and older with type 2 inflammation whose symptoms are inadequately reduced by other treatments.

In September 2020, new long-term data from a Phase III open-label extension trial showed sustained improvement in lung function and reduction in severe exacerbations in adults and adolescents with moderate-to-severe asthma. On May 17, 2021, detailed results from a Phase III trial showed Dupixent significantly reduced severe asthma attacks, and within two weeks rapidly improved lung function in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma with evidence of type 2 inflammation. Moreover, Dupixent significantly improved overall asthma symptom control and reduced an airway biomarker of type 2 inflammation, called fractional exhaled nitric oxide (FeNO), that plays a major role in asthma.

In October 2021, the FDA approved Dupixent as an add-on maintenance treatment for patients aged 6 to 11 years with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma, thereby bringing a new treatment for children who may be suffering from life-threatening asthma attacks and poor lung function affecting their ability to breathe, which could potentially continue into adulthood. On April 7, 2022, the European Commission approved Dupixent for use in children aged 6 to 11 years as an add-on maintenance treatment for severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO), whose symptoms are inadequately reduced with medium to high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.

Chronic rhinosinusitis with nasal polyposis (CRSwNP)

CRSwNP is a chronic disease of the upper airway that obstructs the sinuses and nasal passages. It can lead to breathing difficulties, nasal congestion and discharge, reduced or loss of sense of smell and taste, and facial pressure.

In June 2019, the FDA approved Dupixent for use with other medicines to treat CRSwNP in adults whose disease is not controlled. In October 2019, the European Commission approved Dupixent for use as an add-on therapy with intranasal corticosteroids in adults with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.

Eosinophilic esophagitis (EoE)

EoE is a chronic and progressive inflammatory disease that damages the esophagus and prevents it from working properly; swallowing even small amounts of food can be a painful and worrisome choking experience. In severe cases, a feeding tube may be the only option to ensure proper calorific intake and adequate nutrition. Of the approximately 209,000 patients aged 12 years and older living with EoE in the U.S. who are treated with therapies not specifically approved for the disease, about 42,000 continue to experience symptoms despite multiple treatments.

On September 14, 2020, the FDA granted Breakthrough Therapy designation to Dupixent for the treatment of patients 12 years and older with EoE, and subsequently accepted the file for Priority Review on April 4, 2022. On May 20, 2022, the FDA approved Dupixent to treat patients with EoE aged 12 years and older. With this approval, Dupixent became the first and only medicine specifically indicated to treat EoE in the U.S.

On December 16, 2022, EMA’s CHMP adopted a positive opinion, recommending the approval of dupilumab in the EU to treat adults and adolescents with EoE. On January 30, 2023, the EC expanded marketing authorization for Dupixent in the EU to treat EoE in adults and adolescents 12 years and older, submissions to regulatory authorities in additional countries are planned in 2023.

There are no approved treatments specifically indicated for children under 12 years of age with EoE. On July 14, 2022, a Dupixent Phase III trial showed positive results in children aged 1 to 11 years with EoE, making this the fifth pediatric pivotal trial across three type 2 inflammatory diseases to reinforce the well-established efficacy and safety profile of Dupixent. The corresponding data will be submitted to regulatory authorities around the world, starting with the FDA in 2023.

Prurigo Nodularis (PN)

Prurigo nodularis is a chronic, debilitating skin disease with underlying type 2 inflammation and has one of the highest impacts on a patient’s quality of life among inflammatory skin diseases due to the extreme itch it causes. Those with prurigo nodularis experience intense, persistent itch, with thick skin lesions (called nodules) that can cover most of the body. The disease is often painful – with burning, stinging and tingling of the skin – and can negatively affect mental health, daily living activities and social interactions. High-potency topical steroids are commonly prescribed but are associated with safety risks if used long-term.

The FDA evaluated the Dupixent application for prurigo nodularis under Priority Review on May 31, 2022. On September 29, 2022, the FDA approved Dupixent for the treatment of adult patients with prurigo nodularis. With this approval, Dupixent became the first and only medicine specifically indicated to treat prurigo nodularis in the U.S. The FDA approval was based on data from two Phase III trials evaluating the efficacy and safety of Dupixent in adults with prurigo nodularis. Efficacy in these trials assessed the proportion of subjects with clinically meaningful reduction in itch, clearing of skin, or both. On December 15, 2022, the EC has expanded the marketing authorization for Dupixent in the EU to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy, after the positive recommendation earlier on November 11, 2022.

Chronic Spontaneous Urticaria (CSU)

CSU is a chronic inflammatory skin disease characterized by the sudden onset of hives on the skin and/or swelling deep under the skin. Despite standard-of-care treatment, people with CSU often experience symptoms, including a persistent itch or burning sensation, which can be debilitating and significantly impact quality of life. Swelling often occurs on the face, hands and feet, but can also affect the throat and upper airways. On July 29, 2021, a pivotal Phase III trial evaluating Dupixent in patients with moderate-to-severe CSU met its primary endpoints and all key secondary endpoints at 24 weeks. Adding Dupixent to standard-of-care antihistamines significantly reduced itch and hives for biologic-naive patients, compared to those treated with antihistamines alone (placebo) in Study A (the first of two trials) of the LIBERTY CUPID clinical program.

Study B of the clinical trial evaluated Dupixent in adults and adolescents who remain symptomatic despite standard-of-care treatment and are intolerant or incomplete responders to an anti-IgE therapeutic (omalizumab). Although positive numerical trends in reducing itch and hives were observed, the study was stopped due to futility based on a pre-specified interim analysis. The safety data were generally consistent with the known safety profile of Dupixent in its approved indications. In December 2022, CSU was submitted to FDA, if granted Dupixent has the potential to add additional ~308K patients in the U.S.

Life Cycle Management

Dupixent is being evaluated in clinical development programs for diseases that are driven by type 2 inflammation. These include, chronic obstructive pulmonary disease (COPD), chronic inducible cold urticaria (CINDU), bullous pemphigoid (BP), chronic rhinosinusitis without nasal polyposis (CRSsNP), and allergic fungal rhinosinusitis (AFRS).

Dupixent is developed and commercialized in collaboration with Regeneron. There are ongoing opposition proceedings in Europe related to Dupixent initiated by Sanofi and Regeneron against Amgen and Immunex.

Neurology & Immunology

Multiple Sclerosis

Multiple sclerosis (MS) is an autoimmune neurological disease in which a person’s immune system attacks the central nervous system, damaging myelin, the protective sheath that covers nerve fibers. This causes a break in communication between the brain and the rest of the body, ultimately destroying the nerves themselves, and causing irreversible damage. More than 2.5 million people suffer from MS worldwide.

The company’s MS franchise consists of Aubagio (teriflunomide), a once-daily, oral immunomodulator, and Lemtrada (alemtuzumab), a monoclonal antibody. Both products treat patients with relapsing forms of MS.

Aubagio

Aubagio (teriflunomide), a small molecule immunomodulatory agent with anti-inflammatory properties, is a once-daily oral therapy.

Aubagio is approved in more than 80 countries around the world, including the U.S. (since September 2012) for the treatment of patients with relapsing forms of MS; the EU (since August 2013) for the treatment of adult patients with relapsing remitting MS; and China (since July 2018). In June 2021, the European Commission (EC) approved Aubagio for the treatment of pediatric patients aged 10 to 17 years with relapsing-remitting multiple sclerosis (RRMS). In the European Union, generic competition is expected in the fourth quarter of 2023.

In 2017, Sanofi reached settlement with all 20 generic Aubagio ANDA first filers, granting each a royalty-free license to enter the U.S. market on March 12, 2023.

Lemtrada

Lemtrada (alemtuzumab) is a humanized monoclonal antibody targeting the CD52 antigen. Lemtrada is administered by intravenous infusion as two short courses 12 months apart; for the majority of patients no further treatment is necessary, making Lemtrada the only disease-modifying therapy (DMT) that can provide long term durable efficacy in the absence of continuous dosing.

Lemtrada is approved in more than 70 countries, including the EU (since September 2013) and the U.S. (since November 2014). Because of its safety profile, the FDA approved the use of Lemtrada in patients with relapsing forms of MS who have had an inadequate response to two or more drugs indicated for the treatment of MS, and included a black-box warning on potential side effects. In the U.S., Lemtrada is only available through a restricted distribution program called the Lemtrada Risk Evaluation and Mitigation Strategy (REMS) Program. In January 2020, the EMA updated the indication for Lemtrada to include treatment of relapsing-remitting multiple sclerosis if the disease is highly active despite treatment with at least one disease-modifying therapy, or if the disease is worsening rapidly. The EMA also added new contra-indications for patients with certain heart, circulation or bleeding disorders, and those who have autoimmune disorders other than MS.

Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease causing inflammation, pain, and eventually joint damage and disability.

Kevzara

Kevzara (sarilumab) is a human monoclonal antibody that binds to the interleukin-6 receptor (IL-6R) and has been shown to inhibit IL-6R mediated signaling IL-6 is a cytokine in the body that, in excess and over time, can contribute to the inflammation associated with rheumatoid arthritis. Kevzara is available in 20 countries, including the U.S.

In May 2017, the FDA approved Kevzara for the treatment of adult patients with moderately to severely active RA who have had an inadequate response or intolerance to one or more disease modifying anti-rheumatic drugs (DMARDs), such as methotrexate. In June 2017, the European Commission granted marketing authorization for Kevzara in combination with methotrexate for the treatment of moderately to severely active RA in adult patients who have responded inadequately to – or who are intolerant to – one or more DMARDs, such as methotrexate. An sBLA for Kevzara in polymyalgia rheumatica (PMR) is under priority review by the FDA, and the product is also being investigated in Polyarticular Juvenile Idiopathic Arthritis and Systemic Juvenile Arthritis.

Kevzara is developed and commercialized in collaboration with Regeneron.

Rare Diseases

The company’s Rare Diseases business is focused on products for the treatment of rare genetic diseases and other rare chronic debilitating diseases of high unmet medical need, including lysosomal storage disorders (LSDs), a group of metabolic disorders caused by enzyme deficiencies.

Cerezyme

Cerezyme (imiglucerase) is an enzyme replacement therapy used to treat Gaucher disease, a chronic, inherited, progressive and potentially life-threatening LSD. Gaucher disease is caused by deficiency of the enzyme glucocerebrosidase; this causes a fatty substance called glucosylceramide (also called GL-1) to build up in certain areas of the body, including the spleen, liver, and bone. Gaucher disease exhibits diverse manifestations, a broad range of age of onset of symptoms, and a wide clinical spectrum of disease severity. It is estimated that Gaucher disease occurs in approximately one in 120,000 newborns in the general population and one in 850 in the Ashkenazi Jewish population worldwide, but incidence and patient severity vary among regions. Cerezyme has been marketed in the U.S. since 1994, in the EU since 1997, in Japan since 1998 and in China since 2008, and is approved to treat Type 1 Gaucher disease in more than 85 countries. It has also been approved to treat the systemic symptoms of Type 3 Gaucher disease in most non-U.S. markets, including the EU and Japan.

Cerezyme is typically given by intravenous infusions for 1-2 hours every two weeks at an infusion center, a doctor’s office, or at home as medically appropriate.

Cerdelga

Cerdelga (eliglustat) is the first and only first-line oral therapy for Gaucher disease Type 1 adult patients. A potent, highly specific ceramide analog inhibitor of GL-1 synthesis with broad tissue distribution, Cerdelga has demonstrated efficacy in the treatment of naive Gaucher disease patients and in patients who switch from enzyme replacement therapy. Cerdelga has been approved to treat Type 1 Gaucher disease in the U.S. (2014), and in the EU and Japan (2015). It is also in development for the treatment of type I Gaucher disease in pediatric patients.

Myozyme and Lumizyme

Myozyme (alglucosidase alfa) is an enzyme replacement therapy used to treat both Infantile Onset and Late Onset Pompe disease (IOPD and LOPD). Pompe disease is an inherited, progressive and often fatal neuromuscular disease, caused by a genetic deficiency or dysfunction of the lysosomal enzyme acid alpha-glucosidase (GAA) that results in the build-up of glycogen in the muscles’ cells. For infantile-onset Pompe disease, symptoms begin within a few months of birth and there is impact to the heart in addition to skeletal muscle weakness. Other symptoms include difficulties breathing, frequent chest infections, problems feeding that result in failure to gain weight as expected, and failure to meet certain developmental milestones. Patients with late-onset Pompe disease typically present symptoms any time after the first year of life to late adulthood and rarely manifest cardiac problems. The hallmark symptom of late-onset Pompe disease is skeletal muscle weakness, which often leads to walking disability and reduced respiratory function. Patients often require wheelchairs to assist with mobility and may require mechanical ventilation to help with breathing. Pompe disease occurs in approximately one in 40,000 newborns worldwide, but incidence and patient severity vary among regions.

Myozyme was first approved in 2006 in the EU and has since been approved in more than 70 countries. In the U.S., alglucosidase alfa has been marketed as Lumizyme since 2010.

Nexviazyme

Nexviazyme (avalglucosidase alfa-ngpt) is a monotherapy treatment designed for the entire spectrum of infantile-onset and late-onset Pompe disease (IOPD, LOPD), for both switch and naïve patients. It is the first new treatment option approved for the Pompe community in more than 15 years. Nexviazyme was first approved in the U.S. by the FDA on August 6, 2021 for LOPD patients aged one and above, and has successfully launched in countries like the U.S., Japan and Australia, where the majority of eligible patients have switched to Nexviazyme. On June 24, 2022, the European Commission granted marketing authorization for Nexviadyme as a potential new standard of care for the long-term treatment of both LOPD and IOPD.

In 2023, it is anticipated that Nexviazyme will be launched in many additional markets worldwide. Investment in the clinical development of Nexviazyme continues with an ongoing trial in patients with IOPD aged less than 12 months.

Nexviazyme is administered as a monotherapy enzyme replacement therapy every two weeks.

Fabrazyme

Fabrazyme (agalsidase beta) is an enzyme replacement therapy used to treat Fabry disease. Fabry disease (FD) is a multisystemic, progressive, X-linked inherited disorder of glycosphingolipid metabolism due to deficient or absent lysosomal a-galactosidase A activity resulting in progressive globotriaosylceramide (GL-3) accumulation in the lysosomes of various tissues. Fabry disease affects both genders. With age, progressive organ damage develops, leading to potentially life-threatening renal, cardiac and/or cerebrovascular complications. Fabry disease is characterized by different symptom severities and rates of progression, ranging from classic disease with early symptom onset to late onset disease with cardiac and/or renal complications later in life. Fabry disease occurs in approximately one in 35,000 newborns worldwide, but incidence and patient severity vary among regions. Fabrazyme has been marketed in the EU since 2001 and in the U.S. since 2003, and is approved in more than 70 countries.

Aldurazyme

Aldurazyme (laronidase) is the only approved enzyme replacement therapy for mucopolysaccharidosis type 1 (MPS I), an inherited lysosomal storage disorder caused by a deficiency of alpha-L-iduronidase, a lysosomal enzyme normally required for the breakdown of certain complex carbohydrates known as glycosaminoglycans (GAGs). MPS I is multi-systemic, and children with MPS I are described as having either a severe or attenuated form of the disorder based on age of onset, severity of symptoms, rate of disease progression and whether there is early and direct involvement of the brain. MPS I occurs in approximately one per 100,000 live births worldwide, but incidence and patient severity vary among regions. Aldurazyme has been marketed in the EU and the U.S. since 2003, and is approved in more than 75 countries.

Xenpozyme

Xenpozyme (olipudase alfa) is an enzyme replacement therapy (ERT) designed to replace deficient or defective acid sphingomyelinase (ASMD), an enzyme that allows for the breakdown of the lipid sphingomyelin. In individuals with ASMD, an insufficiency of the ASM enzyme means sphingomyelin is poorly metabolized, potentially leading to lifelong accumulation in and damage to multiple organs.

The significance of the unmet need that Xenpozyme addresses has been recognized by Japan’s PMDA with Sakigake designation, by the EU with PRIME designation, and by the FDA with Breakthrough designation.

Xenpozyme was approved first in Japan on March 28, 2022, followed by Europe on June 24, 2022, a few months before the FDA approval on August 31, 2022.

Xenpozyme is the first and only ERT for the treatment of non central nervous system manifestations of ASMD, with demonstrated improvements in hepatosplenomegaly, pulmonary, liver and hematologic function, dyslipidemia, and growth (children only) in clinical trials of adults and children with ASMD. Xenpozyme is given as an intravenous infusion once every 2 weeks, and the dose is based on body weight.

Oncology

Sarclisa

Sarclisa (isatuximab) is a monoclonal antibody that binds a specific epitope on the human CD38 receptor and has antitumor activity via multiple mechanisms of action. It was approved in March 2020 in the U.S. in combination with pomalidomide and dexamethasone for the treatment of adults with relapsed refractory multiple myeloma (RRMM) who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor, and by the European Commission in May 2020 in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy. Sarclisa is approved for this indication in more than 50 countries.

Sarclisa was approved for a label extension in combination with carfilzomib and dexamethasone in March 2021 in the U.S. for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy, and by the European Commission in April 2021 for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy. The Japanese Ministry of Health, Labor and Welfare (MHLW) granted approval for Sarclisa in combination with carfilzomib and dexamethasone, in combination with dexamethasone, and as monotherapy for RRMM patients in November 2021. Sarclisa is under investigation in the phase III IMROZ trial as a first line treatment for patients with newly diagnosed multiple myeloma who are transplant ineligible. In addition, the phase III IRAKLIA trial investigating the development of a new subcutaneous formulation with an on-body device system was initiated in the second half of 2022.

Sarclisa is also being investigated in Phase II studies as a first/second line treatment for pediatric acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), and warm autoimmune hemolytic anemia.

Libtayo

Libtayo (cemiplimab-rwlc), an immune therapy drug, is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 (programmed cell death protein-1). This may restore immune function through the activation of cytotoxic T cells, thereby avoiding tumor evasion from host immunity.

In September 2018, the FDA approved Libtayo for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. The European Commission granted conditional marketing authorization in July 2019. Libtayo is the only treatment specifically approved and available for advanced CSCC in the EU. CSCC is the second most common form of skin cancer.

Libtayo received approval in the U.S. for the treatment of adult patients with metastatic basal cell carcinoma (mBCC) and for the treatment of adult patients with locally advanced basal cell carcinoma (laBCC) in February 2021. The European Commission granted marketing authorization for Libtayo for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (laBCC or mBCC) who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI) in June 2021. Libtayo received approval in the U.S. in February 2021 for the treatment of adult patients with non-small lung cancer (NSCLC) whose tumors have high PD-L1 expression (Tumor Proportion Score of at least 50%) and are not candidates for surgical resection or definitive chemoradiation or have metastatic disease. In June 2021, the European Commission granted marketing authorization for the first-line treatment of adult patients with NSCLC expressing PD-L1 (in 50% tumor cells), with no EGFR, ALK or ROS1 aberrations, who have locally advanced NSCLC and who are not candidates for definitive chemoradiation, or who have metastatic NSCLC. Libtayo is approved in 37 countries.

Libtayo was filed for label extensions with the FDA and the EMA in 2L+ cervical cancer in 2021. On January 27, 2022, Sanofi and Regeneron announced the voluntary withdrawal of the supplemental Biologics License Application. Discussions with regulatory authorities outside of the U.S. are ongoing.

In November 2022, Libtayo received approval in the U.S. in combination with platinum-based chemotherapy for the first-line treatment of adult patients with locally advanced non-small cell lung cancer with no EGFR, ALK or ROS1 aberrations who are not candidates for surgical resection or definitive chemoradiation, or whose disease is metastatic. Discussions with regulatory authorities outside of the U.S. are ongoing.

On June 1, 2022, Sanofi and Regeneron restructured their IO License and Collaboration Agreement (IO LCA), as signed in 2015, amended in January 2018 and subsequently in September 2021. Under the terms of the Amended and Restated IO LCA, Regeneron holds exclusive worldwide licensing rights to Libtayo with effect from July 1, 2022.

Sanofi stopped consolidating non-U.S. Libtayo sales from the third quarter of 2022 and is entitled to receive a royalty of 11% on worldwide net sales of Libtayo, recognized in line with the pattern of sales. The transaction also includes a time-limited transitional services agreement with Regeneron which includes manufacturing, distribution (for which Sanofi acts as agent), and promotion.

Jevtana

Jevtana (cabazitaxel), a chemotherapy drug and cytotoxic agent, is a semi-synthetic second-generation taxane that prevents many cancer cells from dividing, which ultimately results in destroying many such cells. It is approved in combination with prednisone for the treatment of patients with metastatic castration resistant prostate cancer previously treated with a docetaxel-containing treatment regimen. Jevtana was granted marketing authorization by the FDA in June 2010, by the European Commission in March 2011, and in Japan in July 2014. The product is marketed in over 75 countries. In Europe, generic competition started for Jevtana from the end of March 2021. In the U.S., the Jevtana composition of matter patent expired in September 2021. Sanofi has filed patent infringement suits under the U.S. Hatch-Waxman Act against generic manufacturers for cabazitaxel in the U.S. District Court for the District of Delaware asserting three Orange Book listed U.S. patents for Jevtana. Sanofi has entered settlement agreements with some of the defendants and the suit against the remaining defendants is ongoing.

Fasturtec/Elitek

Fasturtec/Elitek is used for the management of plasma uric levels in patients with leukemia, lymphoma, and solid tumor malignancies receiving anticancer therapies.

Rare Blood Disorders

Eloctate

Eloctate (antihemophilic factor (recombinant), Fc fusion protein) is an extended half-life clotting-factor therapy to control and prevent bleeding episodes in adults and children with hemophilia A. In the U.S., it is indicated for use in adults and children with hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes.

Hemophilia A is a rare, x-linked genetic bleeding disorder characterized by a deficiency of functional coagulation Factor VIII, resulting in a prolonged patient plasma-clotting time. As a consequence, people with hemophilia A bleed for a longer time than normal. Eloctate temporarily replaces the missing coagulation Factor VIII by intravenous injection.

The company markets Eloctate primarily in the U.S. (since 2014), Japan, Canada, Australia, South Korea, Taiwan, and Hong Kong.

Eloctate is developed and commercialized in collaboration with Swedish Orphan Biovitrum AB (Sobi), whose territories include Europe, Russia, the Middle East, and some countries in North Africa.

Alprolix

Alprolix (coagulation Factor IX (recombinant), Fc fusion protein) is an extended half-life clotting-factor therapy to control and prevent bleeding episodes in adults and children with hemophilia B. In the U.S., it is indicated for use in adults and children with hemophilia B for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes.

Hemophilia B is a rare, x-linked genetic bleeding disorder characterized by a deficiency of functional coagulation Factor IX, resulting in a prolonged patient plasma-clotting time. As a consequence, people with hemophilia B bleed for a longer time than normal. Alprolix temporarily replaces the missing coagulation Factor IX by intravenous injection.

The company markets Alprolix primarily in the U.S. (since 2014), Japan, Canada, Australia, New Zealand, South Korea, Taiwan and Hong Kong.

Alprolix is developed and commercialized in collaboration with Swedish Orphan Biovitrum AB (Sobi), whose territories include Europe, Russia, the Middle East, and some countries in North Africa.

Cablivi

Cablivi (caplacizumab) is a bivalent anti-von Willebrand Factor (vWF) Nanobody for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP). Cablivi is the first therapeutic specifically indicated for the treatment of aTTP.

Acquired thrombotic thrombocytopenic purpura is an ultra-rare (3.5-4.5 episodes per million of population), life-threatening, autoimmune-based blood clotting disorder characterized by extensive clot formation in small blood vessels throughout the body, leading to severe thrombocytopenia (very low platelet count); microangiopathic hemolytic anemia (loss of red blood cells through destruction); ischemia (restricted blood supply to parts of the body); and widespread organ damage, especially in the brain and heart. Cablivi has an immediate effect on platelet adhesion and the ensuing formation and accumulation of the micro-clots.

Cablivi was granted marketing authorization by the European Commission in September 2018; by the FDA in February 2019; and by the Japanese PMDA in September 2022. Cablivi is available in 25 countries, including the U.S., the majority of European countries (17), Brazil, Colombia, and five Greater Gulf region states. Additional commercial launches are ongoing.

Cablivi was developed by Ablynx, a Sanofi company since mid-2018.

Enjaymo

Enjaymo (sutimlimab) is a monoclonal antibody targeting the classical complement pathway (CP) specific serine protease (C1s), thereby inhibiting CP activity, which is associated with a variety of immune disorders involving the presence of autoantibodies. Enjaymo is the first-and-only approved therapeutic option approved for hemolytic anemia in adult patients with cold agglutinin disease (CAD).

Enjaymo has previously received Breakthrough Therapy Designation (BTD) and Orphan Drug Designations (ODD) from the FDA, and orphan medicine designation by the European Medicines Agency. After priority review, the product was approved in February 2022 as the first treatment to decrease the need for red blood cell transfusion due to hemolysis in adults with CAD. Enjaymo was approved by the Japanese Ministry of Health, Labor and Welfare in June 2022 and granted marketing authorization by the European Commission in November 2022.

Those approvals were based on the CARDINAL Phase III data, which were published in the New England Journal of Medicine. Additionally, the Enjaymo efficacy sBLA has been granted priority review by the FDA based on the CADENZA trial, with the intention of broadening the indication and including long-term efficacy and safety data.

General Medicines

Sanofi has prioritized core assets with differentiated and/or established profiles that have significant opportunity for growth in key markets. Some of these well-established medicines are the standard-of-care for patients living with diabetes or cardiovascular disease. These core assets include Toujeo, Soliqua, Praluent, Multaq, Lovenox, and Plavix.

Core Assets

Toujeo

Toujeo (insulin glargine 300 units/mL) is a long-acting analog of human insulin, indicated for the treatment of diabetes mellitus in adults. Toujeo has been granted marketing authorization by the FDA (February 2015); the EC (April 2015); and the Ministry of Health, Labor and Welfare (J-MHLW) in Japan, where its approved brand name is Lantus XR (June 2015). Toujeo has now been launched in more than 60 countries, including China since the end of 2020. In January 2020, the EC approved an expansion of the indication to include the treatment of diabetes in adolescents and children (aged 6 years and above).

Toujeo is available in Toujeo SoloSTAR, a disposable prefilled pen which contains 450 units of insulin glargine and requires one-third of the injection volume to deliver the same number of insulin units as Lantus SoloSTAR. In the U.S. (since 2018) and the EU (since 2019), Toujeo is also available in a disposable prefilled pen which contains 900 units of insulin glargine. In India, Toujeo is also available in a dedicated 450-unit cartridge in combination with a dedicated reusable pen (TouStar).

Lovenox/Clexane

Lovenox or Clexane (enoxaparin sodium) is a low molecular weight heparin (LMWH) indicated for use in the prophylaxis and treatment of venous thromboembolism and in the treatment of acute coronary syndrome. Enoxaparin generics are available in the U.S., and biosimilar enoxaparin products have gradually become available across various European countries and in a growing number of international markets. Lovenox or Clexane is marketed in more than 100 countries.

Plavix/Iscover

Plavix or Iscover (clopidogrel bisulfate) is a platelet adenosine diphosphate (ADP) receptor antagonist. It is indicated for the prevention of atherothrombotic events in patients with a history of recent myocardial infarction (MI), recent ischemic stroke or established peripheral arterial disease (PAD), and for patients with acute coronary syndrome (ACS). Plavix is also indicated in combination with acetylsalicylic acid (ASA) for the prevention of atherothrombotic and thromboembolic events in atrial fibrillation, including stroke.

CoPlavix/DuoPlavin, a fixed-dose combination of clopidogrel bisulfate and ASA, is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndrome who are already taking both clopidogrel and ASA.

A number of clopidogrel bisulfate generics have been launched in most markets. Plavix or Iscover are available in more than 80 countries.

Sanofi is involved in two Plavix product lawsuits.

Praluent

Praluent (alirocumab) is a human monoclonal antibody (mAb) for self-administered injection every two weeks or once-monthly. It blocks the interaction of proprotein convertase subtilisin/kexin type 9 (PCSK9) with low-density lipoprotein (LDL) receptors, increasing the recycling of LDL receptors and reducing LDL cholesterol levels.

Praluent is indicated as an adjunct to diet and maximally tolerated statin therapy in certain adult patients with uncontrolled LDL cholesterol. Praluent has been approved in more than 60 countries worldwide, including the U.S. (in 2015), Canada and Switzerland, as well as in the European Union (in 2015). In 2018, the FDA approved a Praluent label update for some patients requiring LDL apheresis therapy. In March 2019 in the EU and in April 2019 in the U.S., Praluent was approved for use in patients with established cardiovascular disease to reduce the risk of cardiovascular events.

In December 2019, Praluent was approved in China, where it started to be commercialized in May 2020.

Since April 2020, Regeneron is responsible for commercialization of Praluent in the U.S., and Sanofi is responsible for all other markets outside the U.S.

Multaq

Multaq (dronedarone) is an oral multichannel blocker with anti-arrhythmic properties for the prevention of atrial fibrillation recurrences in certain patients with a history of paroxysmal or persistent atrial fibrillation. Multaq was approved in the U.S. and in the EU in 2009. Multaq is available in about 35 countries.

Thymoglobulin

Thymoglobulin (anti-thymocyte Globulin) is a polyclonal anti-human thymocyte antibody preparation that acts as a broad immunosuppressive and immunomodulating agent. In the U.S., Thymoglobulin is indicated for the prophylaxis and treatment of acute rejection in patients receiving a kidney transplant, used in conjunction with concomitant immunosuppression. Outside the U.S., depending on the country, Thymoglobulin is indicated for the treatment and/or prevention of acute rejection in organ transplantation; immunosuppressive therapy in aplastic anemia; and the treatment and/or prevention of Graft-versus-Host Disease (GvHD) after allogeneic hematopoietic stem cell transplantation. Thymoglobulin is marketed in over 65 countries.

Mozobil

Mozobil (plerixafor injection) is a hematopoietic stem cell mobilizer. It is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma (NHL) and multiple myeloma (MM). Mozobil is marketed in over 65 countries.

Rezurock

Rezurock (belumosudil) is a selective ROCK2 (rho-associated coiled-coil–containing protein kinase-2) inhibitor. It was approved in July 2021 by the FDA for the treatment of adult and pediatric patients aged 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy. Activities are ongoing to ensure registration in other territories. In April 2022, results from a pooled analysis of Rezurock showed certain organ clinical responses correlated with clinically meaningful changes in patient-reported outcomes (PROs).

Soliqua – Suliqua

Soliqua 100/33 or Suliqua is a once-daily fixed-ratio combination of insulin glargine 100 Units/mL, a long-acting analog of human insulin, and lixisenatide, a GLP-1 receptor agonist. The FDA approved Soliqua 100/33 in November 2016 for the treatment of adults with type 2 diabetes inadequately controlled on basal insulin (less than 60 units daily) or lixisenatide; and in February 2019 for patients uncontrolled on oral antidiabetic medicines. In January 2017, Suliqua (the product’s brand name in Europe) was approved for use in combination with metformin for the treatment of adults with type 2 diabetes to improve glycemic control, when this has not been provided either by metformin alone or by metformin combined with another oral glucose-lowering medicinal product or with basal insulin. In Japan, Soliqua was approved in May 2020 for type 2 diabetes mellitus, where treatment with insulin is required. Suliqua is available in over 40 countries.

Apidra

Apidra (insulin glulisine) is a rapid-acting analog of human insulin, indicated to improve glycemic control in adults and children with diabetes mellitus. It is administered around meal time, and is used in a regimen with an intermediate or long-acting insulin (Apidra has a more rapid onset and shorter duration of action than fast-acting human insulin). Apidra is available in over 100 countries worldwide.

Admelog/Insulin lispro Sanofi

Admelog (or Insulin lispro Sanofi) is a rapid-acting insulin similar to Humalog, another insulin lispro 100 Units/mL. Admelog was approved by the FDA in December 2017, and was also granted marketing authorization as a biosimilar (under the proprietary name Insulin lispro Sanofi) by the European Commission in July 2017. It is used to improve blood sugar control in adults with type 2 diabetes and adults and children (aged 3 years and above) with type 1 diabetes. Admelog was launched in the U.S. and several European countries during 2018.

Truvelog/Insulin aspart Sanofi

Truvelog (also known as TruRapi or Insulin aspart Sanofi) is a rapid-acting insulin similar to Novorapid/Novolog, another insulin aspart 100 Units/mL. It was granted marketing authorization as a biosimilar (under the proprietary name Insulin aspart Sanofi) by the European Commission in June 2020. It is used to improve blood sugar control in adults with type 2 diabetes, and in adults and children (aged 1 year and above) with type 1 diabetes. Insulin aspart Sanofi was launched in several European countries during 2020.

Integrated Digital Care Solutions

Sanofi, in collaboration with Abbott and Biocorp, Health2Sync and Roche, is building a connected set of digital tools and features to support people living with diabetes and taking insulin. Sanofi intends to use aggregated de-identified data to generate insights to inform patients and providers, and to evaluate additional clinical or quality-of-life outcomes. Successful launches in several countries demonstrate the value of the integration of digital tools into a fully connected ecosystem.

Non-Core Assets

Lantus

Lantus (insulin glargine 100 units/mL) is a long-acting analog of human insulin, indicated for once-daily administration for the treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above. Lantus relies on more than 15 years of clinical evidence in diabetes treatment and a well-established safety profile. Approved in the U.S. and the EU in 2000 and in Japan in 2008, Lantus is available in over 130 countries worldwide. Two insulin glargine biosimilars are available in the U.S., two in European markets, and two in Japan.

There are ongoing patent infringement proceedings in the U.S. against Mylan.

Aprovel/Avapro/Karvea

Aprovel, also known as Avapro or Karvea (irbesartan), is an angiotensin II receptor antagonist indicated as a first-line treatment for hypertension and for the treatment of nephropathy in hypertensive patients with type 2 diabetes. The company also markets CoAprovel/Avalide/Karvezide, a combination of irbesartan and the diuretic hydrochlorothiazide. A combination with amlodipine (Aprovasc) has been launched in several emerging market countries.

A number of irbesartan generics have been launched in most markets. Aprovel and CoAprovel are marketed in more than 80 countries. In Japan, the product is licensed to Shionogi Co. Ltd and BMS KK. BMS KK has sublicensed the agreement to Dainippon Pharma Co. Ltd.

Renagel and Renvela

Renagel (sevelamer hydrochloride) and Renvela (sevelamer carbonate) are oral phosphate binders used by chronic kidney disease (CKD) patients on dialysis, as well as late stage CKD patients in Europe to treat hyperphosphatemia, or elevated phosphorus levels, which is associated with heart and bone disease. Renvela is a second-generation buffered phosphate binder.

Generics of sevelamer carbonate are available in the U.S. and in various European countries. A generic of sevelamer hydrochloride was approved in the U.S. in February 2019, and was subsequently launched. Renagel and Renvela are marketed in more than 85 countries. In Japan and several Pacific Rim countries, Renagel is marketed by Chugai Pharmaceutical Co., Ltd and its sublicensee, Kyowa Hakko Kirin Co., Ltd.

Synvisc/Synvisc-One

Synvisc and Synvisc-One (hylan G-F 20) are viscosupplements used to treat pain associated with osteoarthritis. Synvisc and Synvisc-One are marketed in over 60 countries.

Depakine

Depakine (sodium valproate) is a broad-spectrum anti-epileptic that has been prescribed for more than 50 years and remains a reference treatment for epilepsy worldwide. Depakine is also a mood stabilizer, registered in the treatment of manic episodes associated with bipolar disorder (in some countries this indication is branded differently, for example as Depakote in France). The company holds no rights to Depakine in the U.S., and sodium valproate generics are available in most markets.

Sanofi is involved in product litigation related to Depakine.

Taxotere

Taxotere (docetaxel), a chemotherapy drug and cytotoxic agent, is a semi-synthetic taxane. It has been approved for use in 11 indications in five different tumor types (breast, prostate, gastric, lung, and head and neck). Generics of docetaxel have been launched globally.

Sanofi is involved in Taxotere product litigation in the U.S.

Eloxatin

Eloxatin (oxaliplatin), a chemotherapy drug, is a platinum-based cytotoxic agent. In combination with the infusional administration of two other chemotherapy drugs (5-fluorouracil/leucovorin, in the FOLFOX regimen), Eloxatin is approved by the FDA for adjuvant treatment of people with stage III colon cancer who have had their primary tumors surgically removed. It is also approved for the treatment of advanced colorectal cancer and in some countries for the treatment of early-stage gastric cancer. Generics of oxaliplatin have been launched globally. Eloxatin is in-licensed from Debiopharm.

Zaltrap

Zaltrap (aflibercept/ziv-aflibercept) is a recombinant fusion protein. The FDA approved Zaltrap in August 2012 for use in combination with FOLFIRI (a chemotherapy regimen made up of 5-fluorouracil/leucovorin/irinotecan), in patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen. To avoid confusion with Eylea, the FDA assigned a new name, ziv-aflibercept, to the active ingredient. The European Commission approved Zaltrap (aflibercept) in February 2013 to treat mCRC that is resistant to or has progressed after an oxaliplatin-containing regimen.

Zaltrap is marketed in 50 countries.

Amaryl/Amarel/Solosa

Amaryl (glimepiride) is an orally administered once-daily sulfonylurea available in single form or in combination with metformin, indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. A number of glimepiride generics are available in most markets.

Generics

On September 30, 2018, the company completed the divestment of the company’s European generics business Zentiva to Advent International, a U.S. global private equity firm. The company has retained its presence in Generics in emerging markets, especially in Latin America with two top-of-mind brands – Medley (Brazil) and Genfar (Colombia, Peru, Ecuador and Central America) – and also in Russia, South Africa and Turkey.

Vaccine Products

The Vaccines division of Sanofi is a world leader in the vaccine industry and a key supplier of life-saving vaccines all over the world and for publicly funded international stakeholders, such as UNICEF, the Pan American Health Organization (PAHO) and the Global Alliance for Vaccines and Immunization (GAVI).

The Vaccines portfolio includes the following vaccines:

Poliomyelitis, Pertussis and Hib Pediatric Vaccines

Sanofi is one of the key players in pediatric vaccines in both developed and emerging markets, with a broad portfolio of standalone and combination vaccines protecting against up to six diseases in a single injection. Due to the diversity of immunization schedules throughout the world, vaccines vary in composition according to regional specificities.

Tetraxim, a pediatric combination vaccine protecting against diphtheria, tetanus, pertussis and poliomyelitis (polio), was first marketed in 1998. As of December 31, 2022, the vaccine has been launched in close to 90 countries outside the U.S.

Pentaxim, a pediatric combination vaccine protecting against diphtheria, tetanus, pertussis, polio and Hemophilus influenzae type b (Hib), was first marketed in 1997. As of December 31, 2022, the vaccine has been launched in more than 100 countries outside the U.S. In most European, Latin American, Asian and the Middle Eastern markets, Pentaxim is being gradually replaced by Hexaxim.

Hexaxim/Hexyon/Hexacima is a fully liquid, ready-to-use 6-in-1 (hexavalent) pediatric combination vaccine that provides protection against diphtheria, tetanus, pertussis, polio, Hib and hepatitis B. Hexaxim is the only combination vaccine, including acellular pertussis (acP) and inactivated polio vaccines (IPV) prequalified by the WHO. Hexaxim is now available in more than 100 countries outside the U.S.

Pentacel, a pediatric combination vaccine protecting against diphtheria, tetanus, pertussis, polio and Hib, was launched in the U.S. in 2008.

Quadracel is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis and poliomyelitis, used in children aged 4 through 6 years as a fifth dose in the diphtheria, tetanus, pertussis vaccination (DTaP) series, and as a fourth or fifth dose in the inactivated poliovirus vaccination (IPV) series.

Shan5 is a 5-in-1 (whole-cell pertussis based) combination vaccine protecting against five diseases (diphtheria, tetanus, pertussis, Hib and hepatitis B). Following a strategic assessment of the whole-cell pertussis market, Sanofi has decided to cease the production of the Shan5 and Shan6 vaccines produced in Hyderabad, India.

Act-Hib is a standalone vaccine protecting against Hib, and is mainly distributed in the U.S., Japan and China in conjunction with pertussis combination vaccines that do not contain the Hib valence.

Sanofi is a leading provider of polio vaccines and has been a partner of the Global Polio Eradication Initiative (GPEI) for over 30 years, with more than 13 billion doses of oral polio vaccines (OPV) delivered during that time.

Between 2014 and 2022, Sanofi has provided 395 million doses of inactivated polio vaccine to Unicef, to support the WHO ‘Polio End Game’ strategy for the world's 73 poorest countries.

Vaxelis is a hexavalent combination vaccine protecting against diphtheria, tetanus, pertussis, polio, Hib and hepatitis B. This vaccine (developed and distributed in partnership with Merck) was approved in 2016 by the EMA and is distributed in various EU countries. Vaxelis was approved by the FDA in December 2018, becoming the first hexavalent vaccine to be approved in the U.S., and launched in this country in June 2021.

Meningitis Vaccines

Menactra, the first quadrivalent conjugate vaccine against meningococcal meningitis (serogroups: A, C, Y, and W-135), one of the deadliest forms of meningitis, is indicated for people aged 9 months through 55 years. Since launch, it has become a strong leader in the meningitis quadrivalent market, globally and in the U.S. It is also commercialized in a number of countries, including Canada, several Middle Eastern countries, and numerous other countries (excluding Europe). Menactra was the first fully liquid (no reconstitution needed) meningitis quadrivalent conjugated vaccine, and more than 100 million doses of this vaccine have been distributed since launch.

MenQuadfi is a novel fully-liquid meningococcal quadrivalent conjugated vaccine expected to have a broad age indication from infants (6 weeks) to the elderly, with flexible dosing schedules. MenQuadfi is the first and only quadrivalent ACWY vaccine to demonstrate superior immune response against serogroup C in toddlers compared to a monovalent serogroup C vaccine (standard-of-care in multiple markets in Europe and internationally). It is expected to be available worldwide, progressively replacing Menactra, and allowing Sanofi to enter the European meningococcal market. MenQuadfi was approved in the U.S. in April 2020 for people aged two years and above. It was also approved in Australia, Canada, the EU and other European Economic Area countries in the fourth quarter of 2020, and subsequently in Argentina, Brazil and Chile, for people aged 12 months and above. MenQuadfi has also recently been approved in Japan, and marketing authorization is pending in numerous other countries. Extension of the age indication down to six weeks of age will follow submission of additional Phase III data. MenQuadfi was launched in the U.S. and Europe in 2021.

Booster Vaccines

Adacel is the first trivalent booster vaccine offering protection against diphtheria, tetanus and pertussis. The vaccine can be used from 4 years of age following primary immunization and is the first Tdap vaccine indicated for use during pregnancy for protection against pertussis in newborns. It is available in 55 countries, including the U.S. and other countries mostly in Europe, Asia and Latin America.

Repevax/Adacel-Polio is a combination vaccine that provides protection against diphtheria, tetanus, pertussis and polio. It is the first Tdap-IPV vaccine indicated for use during pregnancy for protection against pertussis in newborns. It is marketed in 26 countries outside the U.S., with a strong focus on European markets (such as France and Germany).

Travel and Endemic Vaccines

Sanofi provides a wide range of travel and endemic vaccines, including hepatitis A, typhoid, cholera, yellow fever and rabies vaccines. These products are used in endemic settings in the developing world and are the foundation for important partnerships with governments and organizations, such as UNICEF. They are also used by travelers and military personnel in industrialized countries and in endemic areas.

Influenza Vaccines

Sanofi is a world leader in the production and marketing of influenza vaccines, offering several distinct influenza vaccines that are sold globally to meet growing demand.

Fluzone Quadrivalent is a quadrivalent inactivated influenza vaccine, produced in the U.S., containing two type A antigens and two type B antigens in order to provide increased protection against more circulating strains of influenza viruses. Fluzone Quadrivalent/FluQuadri is available in 7 countries (including the U.S.) for children aged over six months, adolescents and adults. Fluzone 0.5 ml QIV is the currently-licensed standard dose (15 µg/strain) quadrivalent influenza vaccine for ages 6 months and older.

Fluzone High-Dose Quadrivalent, designed specifically to provide greater protection against influenza for people aged 65 years and older, was approved by the FDA in November 2019. It has now fully replaced Fluzone High-Dose Trivalent, and contains two influenza A and two influenza B strains at 60 µg/strain. Fluzone High-Dose Quadrivalent was approved in the EU in the second quarter of 2020, under the name Efluelda, indicated for adults aged 60 years and above. Both Fluzone High-Dose Quadrivalent and Efluelda have been available since the 2020/21 influenza season. As of December 31, 2022, this product has been distributed to 16 countries worldwide.

Flublok is a quadrivalent recombinant protein based influenza vaccine indicated for adults aged 18 years of age and older. Flublok is licensed in the U.S. and Hong Kong. This same recombinant protein-based influenza vaccine is also licensed under the brand name Supemtek in Canada, the United Kingdom, the European Union and Switzerland.

Vaxigrip is a trivalent influenza vaccine, containing two antigens against type A influenza viruses and one antigen against type B influenza viruses. It has now been replaced by VaxigripTetra in most countries in which it is commercialized.

VaxigripTetra is the quadrivalent (QIV) version of Vaxigrip, including two antigens against A strains of influenza viruses and two antigens against B strains. Compared to the trivalent influenza vaccine, it contains an additional influenza B strain; it was licensed in 2016 and has been launched in more than 95 countries since 2017. VaxigripTetra is not licensed in the U.S. where Fluzone Quadrivalent, which is produced in the U.S., is distributed.

COVID Vaccine

COVID-19 recombinant adjuvanted vaccine: VidPrevtyn Beta is a recombinant spike protein vaccine developed in partnership with GSK and using GSK’s AS03 adjuvant. It is indicated as an adult booster to protect against SARS-CoV-2 infections. Phase III results demonstrated significant vaccine efficacy against symptomatic infection with a Beta variant-containing vaccine in the face of an Omicron variant predominated pandemic period. Significant efficacy was demonstrated in naive individuals and individuals previously infected or vaccinated. These results, coupled with data from comprehensive studies to evaluate the vaccine as a heterologous booster for people initially vaccinated with Emergency Use Authorization (EUA) vaccines, supported VidPrevtyn Beta's full marketing authorization for the booster indication in both the EU and the U.K. The first doses were supplied at the end of 2022.

Consumer Healthcare

In 2022, the company progressed further in building and simplifying the company’s stand-alone Consumer Healthcare (CHC) organization within Sanofi. Almost all of the newly-created CHC legal entities required to establish the standalone organization are now operational, and the company’s portfolio has been significantly simplified by way of divestments with just 140 brands currently, down from 250 eighteen months ago. Recently, additional critical support functions have been brought together under the single CHC umbrella, including People & Culture, Finance, Digital and Legal, Ethics & Business Integrity. This represents a key step in the company’s journey to build a stand-alone CHC business, accelerating the full integration of the company’s operating model while enhancing the speed and relevancy of the company’s engagement with the company’s consumers.

The company’s CHC sales are supported by a range of products, including the following brands:

Allergy, Cough & Cold

Allegra comprises a range of fexofenadine HCl-based products. Fexofenadine is an anti-histamine for relief from allergy symptoms, including sneezing, runny nose, itchy nose or throat, and itchy, watery eyes. The Allegra brand family is sold in more than 80 countries across the world.

Mucosolvan is a cough brand with many different formulations. It contains the mucoactive agent ambroxol; this stimulates synthesis and release of surfactant. It is sold in various countries in Europe, Latin America, Asia, and Russia.

Pain

Doliprane offers a range of paracetamol/acetaminophen-based products for pain and fever with a wide range of dosage options and pharmaceutical forms, and is sold mainly in France and various African countries.

The Buscopan range (hyoscine butylbromide) has an antispasmodic action that specifically targets the source of abdominal pain and discomfort. It is sold across the globe.

The company also has local pain brands, such as Eve in Japan; Dorflex and Novalgina in Brazil; and Icy Hot and Aspercreme in the U.S.

Digestive

Dulcolax products offer a range of constipation solutions from predictable overnight relief to comfortable natural-feeling relief. The products are sold in over 80 countries. Dulcolax tablets contain the active ingredient bisacodyl or sodium picosulfate, which works directly on the colon to produce a bowel movement.

Enterogermina is a probiotic indicated for the maintenance and restoration of intestinal flora in the treatment of acute or chronic intestinal disorders. Enterogermina is sold primarily in Europe, and in Latin America and parts of Asia.

Essentiale is a natural soybean remedy to improve liver health. It is composed of essential phospholipids extracted from highly purified soya and contains a high percentage of phosphatidylcholine, a major component of the cell membrane. Essentiale is used in fatty liver disease and is sold mainly in Russia, Eastern Europe, various countries in Southeast Asia, and China.

Zantac 360° products are for the prevention and relief of heartburn, with a new formula launched in 2021 in North America.

Nutritional

Nutritionals include a range of products to maintain general health, provide immune system support, or supplement vitamin deficiencies. These products help manage energy, stress, sleep and anxiety, and include a number of brands across the globe, including Nature’s Own in Australia to improve and maintain health; Pharmaton (mainly in Europe and Latin America); Magne B6 in Europe; and a range of sleep brands, including Novanuit in Europe, Unisom in the U.S. and Drewell in Japan.

Other

Gold Bond offers a broad range of products, including daily body lotions, anti-itch products, moisturizing and soothing lotions, body and foot creams and powders for eczema. Gold Bond is only sold in the U.S.

Products in Development

Oncology

Tusamitamab ravtansine (SAR408701) is an antibody drug conjugate (ADC) that binds to CEACAM-5, a cell-surface glycoprotein that is highly expressed in non-small cell lung cancer (NSCLC), gastric cancer and other cancers. The compound is being evaluated in Phase III (CARMEN-LC03) for the second- and third-line treatment of metastatic non-squamous NSCLC (NSQ NSCLC) with CEACAM-5 positive tumors. In addition, two Phase II studies are ongoing to evaluate the activity of the drug in combination with ramucirumab (CARMEN-LC04) or with pembrolizumab (CARMEN-LC05) in patients with metastatic NSQ NSCLC. Tusamitamab ravtansine is also being evaluated in two Phase II studies, respectively in patients with CEACAM-5 positive advanced solid tumors (CARMEN-BT01) and in patients with gastric cancer in combination with ramucirumab (CARMEN-GC01). According to the agreement between Sanofi and Innovent Biologics, both companies are committed to accelerating the development and commercialization of tusamitamab ravtansine, combining with sintilimab, the leading checkpoint inhibitor in China.

Alomfilimab (SAR445256) is a fully human IgG1 anti-ICOS antibody with a dual mode of action, depleting ICOS high intra-tumoral T regulatory cells and stimulating ICOS low T effector cells, being investigated in Phase II for the treatment of solid tumors.

SAR444245 is a non-alpha durably pegylated interleukin-2 (IL-2) for which a new Phase I/II program is planned to be initiated in 2023 in solid tumors, to solidify the foundation for a best-in-class target profile. The revision of the clinical program was based on emerging external and internal data about non-alpha IL-2’s mechanism of action and therapeutic potential. A decision was taken in 2022 to discontinue the Phase II trials (in advanced skin cancers, head & neck cancers, non-small cell lung cancer/mesothelioma and lymphoma) with the current 3-weekly dose schedule, as the efficacy observed in an early look at the data was lower than projected; however, this decision was not based on any safety-related issues.

SAR441000 is an intratumoral immunotherapy that uses mRNA to encode cytokines and stimulate both innate and adaptive arms of the immune system to maximize anti-tumor activity. It is developed in collaboration with BioNTech for the treatment of solid tumors. A Phase I study assessing SAR441000 as monotherapy and in combination with cemiplimab in patients with advanced solid tumors, including melanoma, is ongoing.

SAR442257, an anti-CD3/CD28/CD38 trispecific monoclonal antibody, is being evaluated in Phase I for the treatment of multiple myeloma/non-Hodgkin lymphoma.

SAR444881, a monoclonal antibody targeting the Ig-like transcript 2 (ILT2) receptor developed with Biond Biologics for the treatment of solid tumors, is being evaluated in Phase I.

SAR445419 is an off-the-shelf NK cell therapy being evaluated in Phase I. A new patient cohort in the Ohio State University study evaluating SAR445419 for the treatment of relapsed/refractory acute myeloid leukemia started enrollment in 2022.

SAR443216 is a T cell engager with a trispecific antibody format designed to target HER2 (on tumor cells), CD3 (on T cells) and CD28 (a co-receptor for T cell activation), respectively. SAR443216 is being evaluated in Phase I for the treatment of gastric cancer.

SAR443579 is a NKp46/CD16-based NK cell engager with a multispecific antibody format developed in partnership with Innate Pharma. SAR443579 is being investigated in a Sanofi-sponsored Phase I/II clinical trial in patients with relapsed or refractory acute myeloid leukemia, B-cell acute lymphoblastic leukemia or high risk-myelodysplasia.

SAR445710 is an anti PD-L1/IL-15 fusion protein being evaluated in Phase I in patients with solid tumors.

SAR446309, an HER2-based T cell engager acquired from Amunix Pharmaceuticals, entered clinical development in 2022 for the treatment of solid tumors. SAR446309 is evaluated, alone and in combination with pembrolizumab, in a Phase I clinical trial in patients with locally advanced or metastatic HER2-expressing cancers.

SAR444200 is a GPC3-based T cell engager designed with a NANOBODY VHH format that entered clinical development in 2022. SAR444200 is being evaluated in Phase I in patients with advanced solid tumors.

SAR445877 is an anti PD1/IL-15 fusion protein that entered clinical development in 2022, with a Phase I trial initiated in patients with solid tumors.

Immunology & Inflammation

Itepekimab (SAR440340) is a human anti-IL33 monoclonal antibody derived from the company’s alliance with Regeneron that is being evaluated in a Phase III clinical program (AERIFY-1 and AERIFY-2 studies) for the treatment of chronic obstructive pulmonary disease in former smokers; a cohort of current smokers is also assessed in AERIFY-2. In October 2022, a two-part open label prospective mechanistic study in former and current smokers (AERIFY-3) enrolled its first patients.

Amlitelimab (SAR445229), an anti-OX40L monoclonal antibody, is in Phase II for the treatment of adults with moderate to severe atopic dermatitis. In 2022, a Phase II study (TIDE-asthma) was initiated to assess add-on therapy with amlitelimab in adults with moderate-to-severe asthma.

Rilzabrutinib (SAR444671) is a covalent and reversible inhibitor of Bruton’s tyrosine kinase under development for the treatment of autoimmune/inflammatory diseases. In 2022, the ongoing Phase II trials assessing rilzabrutinib for the treatment of IgG4-related disease and atopic dermatitis, respectively, were pursued. In addition, two Phase II studies have enrolled their first participants in adults with moderate-to-severe asthma and in chronic spontaneous urticaria (CSU), respectively. Rilzabrutinib is also being evaluated for the treatment of immune thrombocytopenia and warm autoimmune hemolytic anemia (see details below in section e) Rare Blood Disorders).

Eclitasertib (SAR443122) is a small molecule against the receptor-interacting serine/threonine-protein kinase 1 (RIPK1) developed in collaboration with Denali. A proof-of-concept Phase II study assessing the efficacy and safety of eclitasertib in patients with cutaneous lupus erythematosus is ongoing. In 2022, a Phase II study evaluating eclitasertib in patients with ulcerative colitis was initiated.

Atuzabrutinib (SAR444727), an inhibitor of Bruton’s tyrosine kinase, is under investigation in Phase II as a topical agent for the treatment of atopic dermatitis.

Frexalimab (SAR441344), an anti-CD40L monoclonal antibody developed in collaboration with Immunext, is being investigated in two Phase II trials for the treatment of Sjogren’s syndrome and systemic lupus erythematosus, respectively. SAR441344 is also being evaluated in multiple sclerosis.

SAR445088, a complement C1s inhibitor already under clinical development, entered an additional Phase II study in 2022, assessing the compound for the treatment of patients at risk of antibody-mediated rejection (AMR) or diagnosed with AMR.

SAR444656 is an IRAK4 degrader with potential therapeutic application across multiple indications, including atopic dermatitis. SAR444656 is developed in collaboration with Kymera Therapeutics and is under evaluation in Phase I.

SAR441566, the first oral small molecule TNFa inhibitor evaluated in Phase I, is intended to provide patients an oral alternative to anti-TNFa monoclonal antibodies in the range of inflammatory indications where these have been approved.

SAR442970, a bispecific NANOBODY VHH that combines blockade of TNFa and the immune co-stimulatory regulator OX40L for the treatment of inflammatory indications, is under evaluation in Phase I.

SAR443765 is a bispecific NANOBODY VHH targeting TSLP and IL-13 evaluated in Phase I for the treatment of inflammatory indications.

SAR444336, a pegylated non-beta IL-2 designed to selectively engage CD4+ regulatory T cells (and not on effector T or NK cells) for the treatment of inflammatory indications, is evaluated in Phase I.

SAR444419 is a bispecific NANOBODY VHH blocking TNFa and IL6 that entered clinical development in November 2022 for the treatment of inflammatory indications.

SAR444559, an anti-CD38 monoclonal antibody with engineered format, entered clinical development in December 2022 for the treatment of inflammatory indications.

Neurology

Tolebrutinib (SAR442168), an orally administered Bruton’s tyrosine kinase (BTK) inhibitor designed to access the brain and spinal cord by crossing the blood-brain barrier and impacting immune cell and brain cell signaling, is being investigated in Phase III trials. Following written notification from the FDA in July 2022 requesting additional data, Sanofi provided the information with the aim of lifting the partial clinical hold (recruitment pause). In relapsing multiple sclerosis (MS), the Phase III studies GEMINI 1 and GEMINI 2 reached their respective target enrollment in 2022. Recruitment was completed in December 2022 in the Phase III trial HERCULES in non-relapsing secondary progressive MS, an area of highest unmet medical need in MS with no treatment available. In primary progressive MS, recruitment is ongoing in the Phase III trial PERSEUS. The Phase III study URSA evaluating tolebrutinib in patients with moderate-to-severe myasthenia gravis (MG) was discontinued in 2022 after careful evaluation of the emerging competitive treatment landscape.

Frexalimab (SAR441344) is a monoclonal antibody against CD40L, a key immune costimulatory component involved in MS, being evaluated in a Phase II trial.

SAR445088, a complement C1s inhibitor, is being assessed in a Phase II trial in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

SAR443820 (also known as DNL788) is a RIPK1 inhibitor developed in collaboration with Denali for the treatment of amyotrophic lateral sclerosis (ALS). In 2022, a Phase II study assessing the safety and efficacy of SAR443820 for the treatment of ALS started enrollment.

SAR446159 (also known as ABL301) is a bispecific antibody targeting both alpha-synuclein and insulin-like growth factor 1 receptor (IGF1R) developed in collaboration with ABL Bio for the treatment of Parkinson’s disease; a Phase I study assessing the safety and tolerability of intravenous SAR446159 was initiated in December 2022.

Rare Diseases

Nexviazyme (avalglucosidase alfa) is a long-term enzyme replacement therapy targeting the mannose-6-phosphate receptor to effectively clear glycogen build-up in muscle cells. This enzyme replacement therapy is approved in the U.S., in Japan and in Europe for the treatment of patients with Pompe disease, a rare disease caused by a deficiency of the enzyme acid alpha-glucosidase (GAA). Nexviazyme is being investigated in a Phase III study for the treatment of patients aged 6 months or younger who are affected by infantile onset Pompe disease.

Venglustat (GZ402671) is an orally administered brain penetrant glucosylceramide synthase (GCS) inhibitor that blocks the conversion of ceramide to glucosylceramide (GL-1). Venglustat is in the development for the treatment of three lysosomal storage diseases: late-onset GM2 gangliosidosis (Tay-Sachs disease and Sandhoff disease), Fabry disease, and Gaucher disease type 3. Recruitment of participants to the Phase III study in late-onset GM2 gangliosidosis was completed early 2022; in this trial, the efficacy and pharmacodynamics of venglustat is being assessed over a two-year period. In 2022, two Phase III trials were initiated to evaluate the impact of venglustat on Fabry disease-specific personalized endpoints. In respect to Gaucher disease type 3, the Phase III study enrolled its first participants in 2022.

SAR442501 is an anti-FGFR3 (fibroblast growth factor receptor 3) antibody (Fab format) that directly targets overactive FGFR3 in achondroplasia, a skeletal dysplasia with high unmet medical need. SAR442501 is being investigated in a Phase I study for the treatment of patients with achondroplasia with unfused growth plates (typically younger than 18 years of age).

SAR443809, a humanized monoclonal antibody that selectively inhibits the activated fragment of factor B (termed Bb) in the alternative pathway of the complement system, is being evaluated in a Phase I trial for the treatment of rare renal diseases.

SAR439459 is a monoclonal antibody targeting transforming growth factor beta (TGFß); in December 2022, a Phase I study was initiated to evaluate the safety, tolerability, and activity of a single dose of SAR439459 in adult participants with Osteogenesis imperfecta, also called brittle bone disease, a rare disease in which bones fracture easily. Orphan Drug Designation was granted by the FDA for this indication.

Rare Blood Disorders

ALTUVIIIO (efanesoctocog alfa/BIVV001) is an investigational factor VIII replacement therapy developed in collaboration with Sobi for people with hemophilia A, a rare and life-threatening bleeding disorder. In 2022, the FDA accepted for priority review the Biologics License Application (BLA) for ALTUVIIIO for the treatment of hemophilia A. On February 22, 2023, the U.S. Food and Drug Administration (FDA) approved ALTUVIIIO. The approval was supported by data from the pivotal XTEND-1 Phase III study, that demonstrated a clinically meaningful prevention of bleeds and superiority to prior factor prophylaxis based on an intra-patient comparison in people 12 years of age or older. A Phase III study evaluating efanesoctocog alfa in pediatric patients younger than 12 years of age is ongoing; availability of data and regulatory submission in the European Union are expected in 2023.

Fitusiran (SAR439774) is a siRNA targeting antithrombin developed in collaboration with Alnylam for the prophylactic treatment of patients with hemophilia A or B, rare congenital bleeding disorders caused by a deficiency of factor VIII and IX, respectively. In 2022, positive data were reported from the Phase III ATLAS-PPX study evaluating the efficacy and safety of once-monthly fitusiran (80 mg) in adults and adolescents (aged 12 years and over) with severe hemophilia A or B who were previously treated with prior factor or bypassing agent prophylaxis. Collectively with results from the ATLAS A/B and ATLAS-INH Phase III studies, these data add to a growing body of evidence supporting the potential of 80 mg dose, monthly fitusiran prophylaxis to transform treatment for all people with hemophilia. The clinical program is continuing with an amended protocol with two lower doses to optimize the benefit/risk profile of fitusiran. Data with lower doses are expected in the second half of 2023; the first submission is planned for 2024. The ATLAS-PEDS study assessing fitusiran in pediatric patients aged 12 years and under is ongoing.

Rilzabrutinib (SAR444671) is being investigated in a Phase III trial for the treatment of adults and adolescents with persistent or chronic immune thrombocytopenia (ITP); the FDA has granted Fast Track Designation for this indication. In 2022, a Phase II study assessing rilzabrutinib in adults with warm autoimmune hemolytic anemia (wAIHA) enrolled its first participants.

SAR445088 is a humanized IgG4 monoclonal antibody that binds to and inhibits C1s, thereby inhibiting classical pathway (CP) of complement activity. Activation of the CP of complement is associated with a variety of immune disorders involving the presence of autoantibodies. Inhibition of autoantibody-mediated CP activation on the surface of erythrocytes via C1s binding prevents complement opsonin deposition on red blood cells and protects them from phagocytosis and extravascular hemolysis in autoimmune hemolytic anemia, such as cold agglutinin disease (CAD); SAR445088 is under evaluation in a Phase II study in this indication.

Line Extensions

Sarclisa (isatuximab) is a monoclonal antibody designed to selectively bind to CD38, a cell surface antigen expressed in multiple myeloma (MM) cancer cells and other hematological malignancies. Based on the Phase III studies ICARIA-MM and IKEMA, Sarclisa is approved in several countries in combination settings for the treatment of adults with relapsed refractory multiple myeloma (RRMM).

In 2022, R&D efforts were pursued to evaluate Sarclisa in combination with current standard and novel treatments across the MM treatment continuum:

The IMROZ Phase III study is assessing the clinical benefit of Sarclisa in combination with bortezomib, lenalidomide and dexamethasone versus bortezomib, lenalidomide and dexamethasone in patients with newly diagnosed MM not eligible for transplant; filing in this indication is expected in 2024.

The IRAKLIA Phase III study comparing subcutaneous to intravenous administration of Sarclisa in combination with pomalidomide and dexamethasone in RRMM patients who have received at least one prior line of therapy enrolled its first participants in July 2022.

The GMMG HDF Phase III study is evaluating the clinical benefit of Sarclisa in combination with lenalidomide, bortezomib and dexamethasone for induction and with lenalidomide for maintenance in patients with newly diagnosed MM. This study is being conducted in collaboration with the German-speaking Myeloma Multicenter Group (GMMG).

The ITHACA Phase III trial is assessing Sarclisa in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone in patients with high-risk smoldering MM.

A Phase II study is ongoing to evaluate Sarclisa in new combinations with emerging novel mechanisms of action in patients with RRMM or in newly diagnosed MM patients.

A Phase II study assessing Sarclisa in combination with chemotherapy in pediatric patients with relapsed/refractory B or T acute lymphoblastic leukemia or acute myeloid leukemia in first or second relapse is ongoing.

Sarclisa is also under investigation in a Phase II trial for the subcutaneous treatment of adults with warm autoimmune hemolytic anemia (wAiHA), a rare blood disorder.

Libtayo (cemiplimab) is a monoclonal antibody targeting the immune checkpoint receptor PD-1 (programmed cell death protein-1), approved in several countries for the treatment of skin cancers (metastatic or locally advanced cutaneous squamous cell carcinoma and basal cell carcinoma), for the treatment of NSCLC, and for second-line treatment of cervical cancer. Libtayo has been jointly developed by Regeneron and Sanofi under a global collaboration agreement originally entered into in 2015.

In January 2022, Sanofi and Regeneron announced the voluntary withdrawal of the supplemental Biologics License Application for second-line treatment of cervical cancer in the U.S. In the last quarter of 2022, Libtayo was approved in Europe and in Japan for second-line treatment of cervical cancer.

In November 2022, Libtayo in chemotherapy combination was approved by the FDA for the first-line treatment of non small cell lung cancer. Libtayo is under review by the EMA in the same indication; the final decision is expected in February 2023.

Dupixent (dupilumab) is a human monoclonal antibody that binds to the IL-4 receptor a subunit and inhibits IL-4 and IL-13 signaling, jointly developed with Regeneron. Dupixent has received regulatory approvals in several countries for use in patients with AD, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), EoE or prurigo nodularis in different age populations; details are provided below.

Atopic Dermatitis

In February 2022, the product was approved in China for the treatment of children aged 6-11 years with moderate-to-severe AD.

In June 2022, it was approved in the U.S. for the treatment of children aged 6 months to 5 years with moderate-to-severe AD.

Asthma

Dupixent was approved in the EU in April 2022 for children aged 6 to 11 years with severe asthma with type 2 inflammation. The approval was based on Phase III data showing significant reduction of severe asthma attacks and also improvement of lung function and health-related quality of life for children.

Eosinophilic Esophagitis (EoE)

In May 2022, the FDA approved Dupixent to treat patients with EoE aged 12 years and older after granting the medicine Priority Review. In January 2023, Dupixent was approved by European Commission for the treatment of patients with EoE aged 12 years and older.

A Phase III trial assessing the investigational use of Dupixent in children aged 1 to 11 years with EoE met its primary endpoint of histological disease remission at 16 weeks with both higher and lower dose weight-tiered regimens. Filing for the treatment of this pediatric population is expected in 2023.

Prurigo Nodularis

Dupixent was approved in the U.S. in September 2022 after Priority Review for the treatment of adults with prurigo nodularis. With this approval, Dupixent became the first and only medicine specifically indicated to treat prurigo nodularis in the U.S. In December 2022, the European Commission expanded the marketing authorization for Dupixent (dupilumab) in the EU to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.

Prurigo nodularis is a chronic, debilitating skin disease with underlying type 2 inflammation and its impact on quality of life is one of the highest among inflammatory skin diseases.

Other Indications

Phase III clinical studies are investigating Dupixent for the treatment of a range of dermatology and respiratory diseases: chronic spontaneous urticaria: submission of the product for this indication in the U.S. was completed in December 2022; bullous pemphigoid; chronic inducible cold urticaria; chronic pruritis of unknown origin; chronic obstructive pulmonary disease; chronic rhinosinusitis without nasal polyps; and allergic fungal rhinosinusitis.

Kevzara (sarilumab), a monoclonal antibody against the IL-6 receptor developed with Regeneron is already marketed in the treatment of moderate to severe rheumatoid arthritis. The product is being evaluated in pivotal Phase IIb studies in pediatric populations for two indications: polyarticular juvenile idiopathic arthritis; filing in this indication is expected in 2023; and systemic juvenile idiopathic arthritis.

Cerdelga (eliglustat) is a potent, highly specific ceramide analog inhibitor of GL-1 synthesis marketed for Gaucher disease type 1 (GD1) in adult patients. A Phase III trial is evaluating Cerdelga for the treatment of pediatric patients with GD1.

Nexviadyme (avalglucosidase alfa) was approved in Europe in 2022 for the long-term treatment of both late-onset and infantile-onset Pompe disease, a rare, progressive and debilitating muscle disorder caused by a deficiency of the enzyme acid alpha-glucosidase (GAA). Outside of Europe, the treatment is marketed under the brand name Nexviazyme.

Cablivi was approved by the Japanese Ministry of Health, Labor and Welfare (MHLW) in September 2022 for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP).

Vaccines

The Vaccines R&D portfolio includes 11 projects in advanced development (including one monoclonal antibody candidate).

Enhancements of Existing Vaccines

Fluzone: QIV HD is a higher dose quadrivalent influenza vaccine licensed in the U.S. and in Europe for the elderly population, who do not respond as well to standard-dose influenza vaccines due to aging of the immune system (immuno-senescence). Safety and efficacy in the pediatric population will be assessed in a Phase III trial.

mRNA Quadrivalent influenza vaccine is a quadrivalent influenza vaccine based on mRNA technology, which is in Phase I. Following results of Phase I, the product should be moving to Phase III in 2023.

Shan6 is an all-in-one liquid hexavalent combination vaccine. It comprises detoxified whole-cell pertussis, as well as diphtheria toxoid, tetanus toxoid, Hemophilus influenzae type b PRP-T, inactivated poliovirus types 1, 2, and 3 and hepatitis B virus components. Shan6 has been approved in India and obtained WHO pre-qualification in November 2022. Following a strategic assessment of the whole-cell pertussis market, Sanofi has decided to cease the production of the Shan5 and Shan6 vaccines produced in Hyderabad, India.

MenQuadfi: Sanofi’s Men ACYW-TT vaccine is the company’s latest advance in meningococcal quadrivalent conjugate vaccination, designed to help protect an expanded patient group, including infants and adolescents through older adults. MenQuadfi is already licensed in the U.S. (for people aged 2 years and over), and in Europe and several other countries (for people aged 12 months and over). Marketing authorization is also pending in additional countries. In January 2022, MenQuadfi received WHO for pre-qualification for people aged 12 months and above. Additionally, Phase III trials are ongoing to evaluate immunogenicity and safety in infants aged 6 weeks and above, and allow for extension of the age indication down to 6 weeks of age.

Rabies Vaccine: A next-generation purified human rabies vaccine (VRVg) is under development, aimed at replacing both of Sanofi’s commercialized rabies vaccines (Imovax Rabies and Verorab). It will be cultured on Vero cells and will be free of animal or human material. VRVg is in Phase III trials in order to support pre and post exposure indications.

Vero Yellow Fever (vYF) vaccine candidate is a next generation freeze-dried live-attenuated yellow fever vaccine produced on a Vero cell line, for subcutaneous and intra-muscular administration in people aged nine months and older. This vaccine aims to replace Stamaril and YF-VAX with a single product. In January 2020, the first Phase I/II trial was initiated in the U.S. In the first quarter of 2023, Phase II data against standard of care will be available.

Novel Targets

Nirsevimab is a monoclonal antibody engineered to have a long half-life, so that only one dose would be needed for the entire respiratory syncytial virus (RSV) season to provide passive immunity and prevent RSV infection in all infants for their first RSV season (and in high-risk infants, for their first and second RSV seasons). Sanofi has an agreement with AstraZeneca to develop and commercialize nirsevimab. The positive primary analysis of the Phase IIb trial, published in the New England Journal of Medicine in July 2020, which demonstrated the safety and efficacy of nirsevimab, has been confirmed and enhanced in other Phase II and Phase III trials. The Phase III MELODY study, initiated in 2019, achieved its primary endpoint of protection against medically attended RSV lower respiratory tract infection in healthy full-term and late pre-term infants. The MEDLEY Phase II/III study, conducted in preterm infants and infants with chronic lung disease or congenital heart disease, showed positive safety and pharmacokinetics when compared to standard of care. Regulatory submissions started in 2022. Nirsevimab, which will be commercialized under the name of Beyfortus, received European and the U.K. approvals in November 2022. The file was also submitted in the U.S., and FDA acceptance was received in January 2023. First launches are expected in 2023. Nirsevimab was also selected by the Japanese Agency for Medical Research and Development as a priority medicine, and received breakthrough therapy designation in China in January 2021. The company initiated a Phase III study in China in November 2021.

RSV Toddler Vaccine: Sanofi has a Cooperative Research and Development Agreement (CRADA) with the U.S. National Institute of Health (NIH) to develop a live attenuated RSV vaccine for immunization of infants aged 6 months and older. The company initiated the Phase I/II study in the U.S. in September 2020, evaluating the safety and effectiveness of two doses of an intranasal delivery device in infants, the goal being to extend the immunity offered by nirsevimab to additional RSV seasons. Positive data from this study were obtained in the fourth quarter of 2022.

RSV Older Adult Vaccine: Sanofi initiated Phase I with an mRNA vaccine against RSV for the older adults population. This vaccine aims at providing protection against RSV as a standalone vaccine, and in combination with other respiratory viruses in the future.

Meningococcal Group B (Men B): this vaccine candidate is intended to provide active immunization against invasive meningococcal disease caused by Neisseria meningitidis serogroup B (Men B) for all age groups. A Phase I/II study was initiated in March 2021 with positive interim data in the fourth quarter of 2022. Early-stage development studies are underway to combine the four meningococcal serogroups represented in MenQuadfi with Men B to advance a pentavalent meningococcal vaccine candidate.

Pneumococcal Conjugate Vaccine (PCV): Sanofi is collaborating with SK Chemicals (South Korea) to develop a 21-valent pneumococcal conjugate vaccine that will provide expanded protection against pneumococcal disease globally in at risk populations and in different age groups. Data from Phase II studies assembled between mid-2022 and mid-2023 will define the pathway to Phase III.

Research and Development (R&D)

Expenditures on research and development amounted to €6,706 million in 2022, comprising €5,067 million in the Pharmaceuticals segment; €187 million in the Consumer Healthcare segment; €936 million in the Vaccines segment; and €516 million allocated to ‘Other’, representing the R&D support function.

Marketing and Distribution

The company has business operations in approximately 90 countries and the company’s products are available in more than 180 countries. The company’s main markets are the United States, Europe, and other countries.

Although specific distribution patterns vary by country, the company sells prescription drugs primarily to wholesale drug distributors, independent and chain retail drug outlets, hospitals, clinics, managed-care organizations and government institutions. Some products in Rare Diseases and Oncology may also be sold directly to physicians. With the exception of Consumer Healthcare products, the company’s drugs are ordinarily dispensed to patients by pharmacies upon presentation of a doctor’s prescription. The company’s Consumer Healthcare products are also sold and distributed through e-commerce, which is a growing trend in consumer behavior. The company’s vaccines are sold and distributed through multiple channels, including physicians, pharmacies, hospitals, private companies and distributors in the private sector, and governmental entities and non-governmental organizations in the public and international donor markets.

Acquisitions

On February 8, 2022, Sanofi acquired the entire share capital of the immuno-oncology company Amunix Pharmaceuticals, Inc. (Amunix), thereby gaining access to Amunix’s innovative Pro-XTEN technology and a promising pipeline of immunotherapies.

Dispositions

On May 3, 2022, Sanofi's General Meeting of Shareholders approved the decision to distribute approximately 58% of the share capital of EUROAPI, a European leader in the development, manufacture, marketing and distribution of Active Pharmaceutical Ingredients (APIs), in the form of an exceptional dividend in kind to Sanofi shareholders. On the dividend payment date of May 10, 2022 (further to the admission of EUROAPI shares to listing on the regulated market of Euronext Paris on May 6, 2022), Sanofi divested control over EUROAPI and its subsidiaries. On June 17, 2022 (the date of delivery of the EUROAPI shares to the French State via the French Tech Souverainete fund), EPIC Bpifrance acquired a 12% equity interest in EUROAPI. Following completion of those transactions, Sanofi retains an equity interest of 30.1% in EUROAPI.

Strategy

The Sanofi ‘Play to Win’ strategy is organized around four key priorities: focus on growth; lead with innovation; accelerate efficiency; and reinvent how the company works to drive innovation and growth.

Patents

The company’s products and patents are subject to challenge by competitors via another abbreviated approval pathway, under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.

Trademarks – Domain names – Copyright

All of the company’s production facilities are good manufacturing practice (GMP) compliant, in line with international regulations.

The company’s main sites are approved by the U.S. FDA:

The Specialty Care facilities in the United States (Framingham MA and Northborough MA), France (Lyon Gerland, Vitry-sur-Seine, Le Trait), Germany (Frankfurt), Ireland (Waterford) and Belgium (Geel);

The General Medicines facilities in Germany (Frankfurt), France (Aramon, Sisteron, Ploermel, Ambarès and Tours), Italy (Anagni and Scoppito), Singapore (Jurong) and the United States (Ridgefield NJ);

The Consumer Healthcare facilities in France (Compiègne) and the United States (Chattanooga TN); and

The Vaccines facilities in France (Marcy l’Etoile, Le Trait, Val-de-Reuil and Neuville-sur-SaÔne), the United States (Swiftwater PA) and Canada (Toronto).

History

The company was founded in 1973. It was formerly known as Sanofi-Aventis and changed its name to Sanofi in 2011. The company was incorporated under the laws of France in 1994.

Country
Founded:
1973
IPO Date:
05/25/1999
ISIN Number:
I_FR0000120578

Contact Details

Address:
46, avenue de la Grande Armée,, Paris, Ile-de-France, 75017, France
Phone Number
33 1 53 77 40 00

Key Executives

CEO:
Hudson, Paul
CFO
de Chatillon, Jean-Baptiste
COO:
Roach, Madeleine