Sanofi Profile
Sanofi is a leading global healthcare company, focused on patient needs and engaged in the research, development, manufacture and marketing of therapeutic solutions.
Sanofi’s activities are organized around the following categories: DUPIXENT, Neurology & Immunology, Rare Diseases, Oncology, Rare Blood Disorders, General Medicines Core Assets and Non-Core Assets, Vaccines, and CHC.
On April 27, 2023, Sanofi announced the completion of its acquisition of Provention Bio, Inc. (‘Provention’), a U.S.-based publicly-traded biopharmaceutical company developing therapies to prevent and intercept immune-mediated diseases, including type 1 diabetes. The acquisition adds TZIELD (teplizumab-mzwv), a therapy for type 1 diabetes, to Sanofi’s core General Medicines asset portfolio.
On September 29, 2023, Sanofi announced that it had entered into a definitive agreement to acquire ownership of QUNOL, a market-leading U.S.-based health & wellness brand. This transaction was intended to strengthen Sanofi CHC in the Vitamin, Mineral and Supplements (VMS) category, one of the largest and fastest-growing consumer health categories in the U.S., focused on the dynamic healthy aging segment. Sanofi’s acquisition of QRIB Intermediate Holdings, LLC was completed on September 29, 2023.
In 2022, Sanofi reported three operating segments: Pharmaceuticals, Vaccines and Consumer Healthcare. As a consequence of (i) progress on the ‘Play to Win’ strategy leading to the creation of the standalone Consumer Healthcare Global Business Unit (GBU); and (ii) organizational changes to Sanofi’s Manufacturing & Supply global function (previously known as Industrial Affairs), with effect from January 1, 2023, the company’s operations have been split into two operating segments: Biopharma and Consumer Healthcare.
The Consumer Healthcare operating segment comprises commercial operations relating to the company’s Consumer Healthcare products, and research, development and production activities and global support functions dedicated to the segment.
The Biopharma operating segment comprises commercial operations and research, development and production activities relating to the company’s Specialty Care, General Medicines and Vaccines franchises, for all geographical territories.
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.
Focus on Growth
DUPIXENT (dupilumab) (in partnership with Regeneron) – By leveraging the product’s unique mechanism of action targeting the type 2 inflammation pathway and its favorable safety profile, the company has raised its DUPIXENT sales peak ambition.
Vaccines – The company’s Vaccines business is expected to deliver mid-to-high single digit net sales growth through differentiated products, market expansions and launches. Contributors to growth are expected to be pediatric combinations; boosters; influenza vaccines; meningitis; and BEYFORTUS, which addresses Respiratory Syncytial Virus (RSV) (in partnership with AstraZeneca). Sanofi has progressed in the field of mRNA technology with the company’s Center of Excellence. At least five First in class / best in class vaccine candidates expected in phase 3 by 2025 across diverse preventative and therapeutic areas.
Pipeline – The company is focusing its investments on priority projects, including six potentially transformative therapies in immunology, hematology, neurology, vaccines and oncology.
Lead with Innovation
The company has been able to shift from a priority asset list to a steady flow of assets in a refocused, consistent pipeline. The company’s pipeline is showing potential opportunities for market-leading products.
To continue fueling the company’s promising pipeline and enhance its position in the company’s core therapeutic areas, the company has:
Entered into a strategic collaboration with Teva to co-develop and co-commercialize asset TEV’574, in Phase 2b clinical trials for the treatment of Ulcerative Colitis and Crohn’s Disease, two types of inflammatory bowel disease;
Established a strategic collaboration with Recludix Pharma to advance a novel oral STAT6 inhibitor in multiple immunological and inflammatory indications;
Expanded an existing collaboration with Scribe Therapeutics to access CRISPR X-Editing (XE) genome editing technologies to advance in vivo genetic medicines for sickle cell and other genomic diseases;
Acquired Provention Bio, adding to the company’s portfolio TZIELD, the first disease-modifying treatment for the delay of Stage 3 type 1 diabetes;
Established a strategic collaboration with BioMap to co-develop Artificial Intelligence (AI) modules to accelerate drug discovery for biotherapeutics;
Entered into an exclusivity agreement with Adocia for M1Pram, an innovative combination of insulin and pramlintide developed by Adocia to become the reference rapid-acting insulin for people with diabetes and obesity;
Entered into an agreement with Janssen Pharmaceuticals to develop and commercialize the vaccine candidate for extraintestinal pathogenic E. coli (9-valent) developed by Janssen, in Phase 3;
Modified an existing collaboration agreement with AstraZeneca, giving Sanofi full commercial control of BEYFORTUS (nirsevimab) and enhanced agility in the U.S.;
Out-licensed the Capeserod Phase 2 program to FirstWave Biopharma so it can be repurposed in gastrointestinal disorders with significant unmet needs, enabled by AI-empowered analyses of the drug’s properties.
Accelerate Efficiency
To embrace the transformative effect offered by digital technologies and advanced data analytics, the company is investing to become the leading digital healthcare platform for employees, patients and providers. This is expected to help the company discover, test and deliver medicines faster, run the company’s business more efficiently, and create engaging digital experiences. The digital transformation required to meet the company’s ambition is under way. The company is using advanced algorithms to harvest real world data to support the company’s R&D efforts. The company is also developing new go-to-market models by enhanced physician engagement through a variety of channels, building precision marketing, and providing better e-commerce capabilities. And in parallel, the company is investigating the possibility of integrating drugs, devices, data and services, to bring innovative solutions to patients across many different disease areas, such as diabetes and atopic dermatitis.
In 2023, the company made further progress regarding the implementation of AI across the business:
In partnership with Aily Labs, the company rolled out plai, an application developed with AI, to more than 23,000 internal users. The application delivers real-time, reactive data interactions and gives a 360° view across the company’s activities, using AI to provide users with timely insights and personalized ‘what if’ scenarios to support informed decision making.
In Research, the company has built multiple AI programs to reduce research times through improved predictive modelling and automate time-sink activities. As a result, AI assists R&D teams to scale and accelerate research processes from a matter of weeks to hours and improve potential target identification in therapeutic areas like immunology, oncology or neurology.
In Manufacturing & Supply, the company has developed an in-house AI-enabled yield optimization solution which learns from past and current batch performance in an effort to enable consistently higher yield levels.
Reinvent How the company Works
To drive implementation of the company’s new culture built on stronger focus, diversity and teamwork, the company has streamlined its executive leadership team from 15 to 12 members.
In 2023, the company progressed further in building and simplifying the company’s stand-alone CHC organization.
In line with the company’s high sustainable development ambitions, Sanofi CHC North America achieved B-corp accreditation in July 2023.
Sanofi’s Corporate Social Responsibility (CSR) strategy aims to build a healthier, more resilient world by ensuring access to healthcare for the world’s poorest people and bringing focus to addressing broader unmet needs.
Sanofi’s CSR Strategy focuses on four building blocks integrated into with the company’s Play to Win core business strategy:
Affordable access – to ensure affordable global access to health, while helping healthcare systems to remain sustainable;
R&D for unmet needs – to be at the cutting edge of R&D innovation, to help people live fully and drive growth;
Planet Care – to minimize the environmental impact of the company’s business through environmental sustainability; and
In & beyond the workplace – to give all Sanofi colleagues the chance to become a leader of change, unlocking the potential of the company’s diverse teams.
Main Biopharma 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, 2023, 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 3 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), Japan (since April 2018), and China (since June 2020).
Atopic Dermatitis
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 six months to 11 years. On May 26, 2020, DUPIXENT was approved as the first biologic medicine for children aged six to 11 years with moderate-to-severe AD. Having accepted DUPIXENT for Priority Review in February 2022, the FDA approved DUPIXENT on June 7, 2022 for children aged six months to five years with moderate-to-severe AD and 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 six 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 six 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 three 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 AD in children aged six months to five years who are candidates for systemic therapy. In March 2023, DUPIXENT was approved by the EC as the first and only targeted medicine for children as young as six months old with severe AD.
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 AD. The indication for children aged six 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 May 2023, DUPIXENT was approved in China to treat moderate to severe AD in infants and children aged six months and older.
On January 22, 2018, the Ministry of Health, Labor and Welfare (MHLW) in Japan granted marketing and manufacturing authorization for DUPIXENT for the treatment of AD in adults not adequately controlled with existing therapies. More recently, on September 25, 2023 DUPIXENT was approved in Japan to treat patients with moderate-to-severe AD aged six months and older.
In April 2023, new late-breaking abstract data from a long-term efficacy open-label study presented at the Revolutionizing Atopic Dermatitis (RAD) 2023 Spring Conference in Washington, DC showed that DUPIXENT demonstrated robust and sustained efficacy with progressive improvement of AD signs and symptoms in patients with moderate-to-severe AD who completed up to five 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 children aged six months to five years reinforced the well-established safety profile of DUPIXENT observed across all other approved age groups. This data is built on the existing 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. In June 2023, the inclusion of the results from the five-year OLE Trial for Adults into the DUPIXENT label was approved in Europe, and in October 2023, by the FDA in the U.S.
In March 2023, positive results from the clinical trial assessing DUPIXENT in adults and adolescents with uncontrolled moderate-to-severe atopic hand and foot dermatitis were presented in a late-breaking session, one of more than 20 DUPIXENT scientific presentations, at the American Academy of Dermatology (AAD) 2023 Annual Meeting. The trial evaluating a biologic for this difficult-to-treat population met its primary and key secondary endpoints. In August 2023, the clinical section of the DUPIXENT label in Europe was updated to include the hand and foot dermatitis population. In January 2024, the DUPIXENT U.S. label was updated with data further supporting use in atopic dermatitis with moderate-to-severe hand and foot involvement.
These Phase 3 data are from the first and only trial evaluating a biologic specifically for this difficult-to-treat population and have also been added to the DUPIXENT label in the European Union, with regulatory submissions underway in additional countries.
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 EC 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 3 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 3 trial showed DUPIXENT significantly reduced severe asthma attacks, and within two weeks rapidly improved lung function in children aged six 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 six 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 EC approved DUPIXENT for use in children aged six to 11 years as an add-on maintenance treatment for severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised FeNO, whose symptoms are inadequately reduced with medium to high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.
In March 2019, DUPIXENT was approved in Japan for treating patients aged 12 years and over with severe or refractory asthma and whose symptoms are inadequately controlled with existing therapies. In November 2023, DUPIXENT received approval in China for the treatment of moderate to severe asthma patients aged 12 years and over with T2 inflammation.
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 EC 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. In March 2020, the Japanese Pharmaceuticals and Medical Devices Agency approved DUPIXENT as add-on maintenance treatment for adults with inadequately controlled CRSwNP.
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. As the disease progresses, patients may continue to experience symptoms despite multiple treatments.
On September 14, 2020, the FDA granted Breakthrough Therapy designation to DUPIXENT for the treatment of patients aged 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, the EMA 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 the marketing authorization for DUPIXENT in the EU to include the treatment of EoE in adults and adolescents aged 12 years and older.
There are no approved treatments specifically indicated for children under 12 years of age with EoE. On July 14, 2022, a DUPIXENT Phase 3 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. In January 2024, DUPIXENT was approved for the treatment of adult and pediatric patients aged one year or older, weighting at least 15 kg, with oesinophilic esophagitis (EoE). The EoE pediatric indication was submitted in the EU in the fourth quarter of 2023.
Prurigo Nodularis (PN)
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 3 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 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 previous positive recommendation on November 11, 2022.
The DUPIXENT prurigo nodularis indication was approved in Japan on June 26, 2023, and in China on September 22, 2023.
Chronic Spontaneous Urticaria (CSU)
On July 29, 2021, a pivotal Phase 3 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 the FDA. In October 2023 the FDA issued a Complete Response Letter (CRL) stating that additional efficacy data are required to support approval; it did not identify any issues with safety or manufacturing. An ongoing clinical trial (Study C) continues to enroll patients; the results, due in late 2024, are expected to provide the additional efficacy data.
Japan's Ministry of Health, Labour and Welfare granted marketing and manufacturing authorization for DUPIXENT for the treatment of chronic spontaneous urticaria in February 2024.
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), bullous pemphigoid (BP), chronic pruritis of unknown origin (CPUO), eosinophilic gastroenteritis (EoG) and ulcerative colitis (UC).
DUPIXENT is developed and commercialized in collaboration with Regeneron.
Neurology & Immunology
Multiple Sclerosis (MS)
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 EC approved AUBAGIO for the treatment of pediatric patients aged 10 to 17 years with relapsing-remitting multiple sclerosis (RRMS).
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. In the European Union, the first generic competitors to AUBAGIO became available in the third quarter of 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.
Bayer Healthcare received contingent payments based on alemtuzumab global sales revenue through September 2023.
Rheumatoid Arthritis
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. In September 2017, KEVZARA obtained manufacturing and marketing approval in Japan as a treatment for rheumatoid arthritis not responding well to conventional treatments. In February 2023, the FDA approved KEVZARA for the treatment of adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate a corticosteroid taper. In October 2023, the FDA accepted the filing for polyarticular Juvenile Idiopathic 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. 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 1 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 / NEXVIADYME (avalglucosidase alfa-ngpt) is a novel mannose-6-phosphate (M6P) enriched enzyme replacement therapy (ERT) treatment designed as a monotherapy for the entire spectrum of infantile-onset and late-onset Pompe disease (IOPD, LOPD), for both switch and naive patients. NEXVIAZYME/NEXVIADYME is scientifically designed to specifically target the M6P receptor, the key pathway for ERT, to effectively clear glycogen build-up in muscle cells. It helps replace the GAA enzyme for people whose bodies do not produce enough. Investment in the clinical development of NEXVIAZYME is continuing, with an ongoing Phase 3 trial in treatment-naive IOPD patients aged less than 12 months. NEXVIAZYME/NEXVIADYME is administered as a monotherapy enzyme replacement therapy every two weeks.
NEXVIAZYME was first approved in the U.S. by the FDA on August 6, 2021 for LOPD patients aged 1 and over. On June 24, 2022, the EC granted marketing authorization for NEXVIADYME as a potential new standard of care for the long-term treatment of both LOPD and IOPD. NEXVIAZYME/NEXVIADYME has successfully launched in 25 countries including the U.S., Japan and Australia. In all launched markets, the vast majority of eligible patients have switched or will be switching to NEXVIAZYME/NEXVIADYME.
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 is seen in all racial and ethnic groups and is an under-diagnosed condition. Prevalence estimates vary across regions. Classic Fabry disease mutations are estimated to be approximately 1:40,000 in males with more wide-ranging estimates for atypical presentations of Fabry in both males and females. 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 two weeks, and the dose is based on body weight.
XENPOZYME has as of December 31, 2023 been launched in eight countries. In 2024, It is anticipated that XENPOZYME will be launched in many additional markets worldwide.
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 EC 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 now approved for this indication in more than 50 countries. In addition the first biologic license application (BLA) for SARCLISA, in combination with pomalidomide and dexamethasone, was accepted by the Chinese health authorities in late 2023.
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 EC 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 3 IMROZ trial as a first line treatment for patients with newly diagnosed multiple myeloma who are transplant ineligible. In December 2023, the IMROZ Trial was reported to have met its primary endpoint; the results will form the basis of a future regulatory submission. In addition, the Phase 3 IRAKLIA trial investigating the development of a new subcutaneous formulation with an on-body device system was initiated in the second half of 2022 and is enrolling in over 20 countries.
SARCLISA is also being investigated with several innovative agents in multiple myeloma in an umbrella Phase 1/2 trial.
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 EC 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 entered settlement agreements with most of the defendants and went to trial against the remaining defendant, Sandoz on one of the patents (the ‘777 patent) in January 2023; see Note D.22.b. to the consolidated financial statements, included at Item 18. of this annual report. The district court issued a final judgment in favor of Sanofi in connection with the JEVTANA patent litigation against Sandoz and on August 2, 2023, Sandoz appealed to the Court of Appeals for the Federal Circuit. On October 5, 2023, Sanofi and Sandoz filed a joint stipulation voluntarily dismissing Sandoz’s Appeal, bringing this matter to conclusion.
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
The Rare Blood Disorders franchise was created in 2018 following Sanofi’s acquisition of Bioverativ and Ablynx.
ALTUVIIIO
ALTUVIIIO (Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein) is a first-in-class high-sustained factor VIII therapy that is designed to extend protection from bleeds with once-weekly prophylactic dosing for adults and children with hemophilia A. 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.
ALTUVIIIO temporarily replaces the missing coagulation factor VIII by intravenous injection. In adults and adolescents, it is the first factor VIII therapy that has been shown to break through the von Willebrand factor ceiling, which imposes a half-life limitation on earlier generation factor VIII therapies. ALTUVIIIO builds on innovative Fc fusion technology by adding a region of von Willebrand factor and XTEN polypeptides to extend its time in circulation.
ALTUVIIIO was first approved in February 2023 by the FDA, which had previously granted Breakthrough Therapy designation in May 2022 (the first factor VIII therapy to receive this designation), Fast Track designation in February 2021, and Orphan Drug designation in 2017. ALTUVIIIO has since been approved the by regulatory authorities in Japan and Taiwan. The EC granted Orphan Drug designation in June 2019, and a marketing authorization application was filed at the European Medecines Agency in May 2023.
ELOCTATE
ELOCTATE (antihemophilic factor (recombinant), Fc fusion protein) is an extended half-life factor VIII therapy 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 factor IX therapy 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 VHH 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 EC in September 2018; by the FDA in February 2019; and by the Japanese PMDA in September 2022. CABLIVI is available in 26 countries including the U.S., the majority of European countries (17), Brazil, Colombia, Japan 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; formerly known as BIVV009) 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).
CAD is a rare, serious, and chronic autoimmune hemolytic anemia, where the body’s immune system mistakenly attacks healthy red blood cells and causes their rupture, known as hemolysis. The disease impacts the lives of an estimated 12,000 people in the U.S., Europe, and Japan and is associated with profound fatigue and increased risk of thromboembolic events and mortality.
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 EC in November 2022.
ENJAYMO is available in the U.S., Japan, Germany, Austria and the Netherlands. Additional commercial launches are ongoing.
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 TZIELD, REZUROCK, TOUJEO, SOLIQUA, PRALUENT, MULTAQ, LOVENOX, and PLAVIX.
Core assets
TZIELD
TZIELD (Teplizumab) is a CD3-directed antibody (CD3 is a cell surface antigen present on T lymphocytes). It was approved by the FDA in November 2022 to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged eight years and older with Stage 2 T1D. The product is marketed in the U.S., with plans for pursuing regulatory approval in other regions. The product is being developed for another indication for patients already in Stage 3 T1D.
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. REZUROCK’s favorable market adoption, especially in the U.S., is a reflection of its clinical profile. The product has been approved in Australia, Canada, Great Britain, Israel, China, and United Arab Emirates with other countries granting accelerated regulatory review processes.
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.
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 six 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).
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 with or without SGLT-2 inhibitors 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. In China SOLIQUA was approved on January 2023, for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to other oral antidiabetic drugs. SOLIQUA received National Reimbursement Drug List (NRDL) status in China in December 2023. SULIQUA is available in over 40 countries. (SOLIQUA is approved in over 80 countries).
Integrated Digital Care Solutions
Sanofi, in collaboration with Biocorp and Glooko, Glooko XT, Health2Sync and Emperra, 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.
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 and in paediatric patients eight years of age and older with heterozygous familial hypercholesterolaemia (HeFH) 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 November 2023, the EMA approved a PRALUENT label update for paediatric HeFh patients aged eight years and older. 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.
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. See Note D.22.c) to the company’s consolidated financial statements, included at Item 18. of this annual report.
MULTAQ
MULTAQ (dronedarone) is an oral multichannel blocker with anti-arrhythmic properties for 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.
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 two 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.
APROVEL/AVAPRO/KARVEA
APROVEL, also known as AVAPRO or KARVEA (irbesartan), is an angiotensin II receptor antagonist indicated in the treatment of hypertension and for the treatment of renal disease in patients with hypertension and type 2 diabetes. Sanofi also markets COAPROVEL/AVALIDE/KARVEZIDE, a combination of irbesartan and the diuretic hydrochlorothiazide. A combination with amlodipine (APROVASC, Aprexevo, Aproxxamlo) has been launched in several 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.
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.
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 products:
RSV protection
In 2023, Sanofi launched BEYFORTUS (nirsevimab-alip), a long-acting monoclonal antibody designed to protect all infants from RSV. It is indicated for protection of all infants in their first RSV season, and for those infants born at high risk who remain particularly vulnerable in their second RSV season as well.
BEYFORTUS is licensed in several countries, primarily in North America and Europe. In 2023, the U.S., France and Spain implemented broad protection programs with BEYFORTUS. In 2024, further licenses and introductions are expected worldwide, including in Japan and China. BEYFORTUS is part of an alliance with AstraZeneca, where Sanofi is the commercial lead and AstraZeneca is the development and manufacturing lead.
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 seven countries (including the U.S.) for children aged over six months, adolescents and adults. FLUZONE 0.5 ml QIV is the licensed standard dose (15 µg/strain) quadrivalent influenza vaccine for ages six 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. 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, 2023, this product has been distributed to 25 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., Hong Kong and Australia. 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.
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.
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, 2023, 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, 2023, the vaccine has been launched in more than 100 countries outside the U.S. In most European, Latin American, Asian and 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. First marketed in 2013, HEXAXIM is 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 four through six 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.
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 15 billion doses of oral polio vaccines (OPV) delivered during that time.
Between 2014 and 2023, Sanofi has provided more than 400 million doses of inactivated polio vaccine to UNICEF, to support the WHO ‘Polio End Game’ strategy for the world’s 73 poorest countries.
VAXELIS
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.
Sales of VAXELIS in the U.S. are booked to the MSP JV and credited to Merck and Sanofi as equity income and therefore are not reported separately in each parent company’s net sales.
Booster Vaccines
ADACEL is the first trivalent booster vaccine offering protection against diphtheria, tetanus and pertussis. The vaccine can be used from four 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 68 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 25 countries outside the U.S., with a strong focus on European markets (such as France and Germany).
Meningitis and Travel & Endemic 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 nine months through 55 years. Since launch, it has become a strong leader in the meningitis quadrivalent market. It is commercialized in a large number of 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 (six 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). MENQUADFI will progressively fully replace MENACTRA. It is already available in the U.S. (for people over two years of age), and in Australia, Canada, Europe, Japan, Argentina, Brazil, and Chile for people aged 12 months and above. Marketing authorization is also pending in numerous other countries. Extension of the age indication down to six weeks of age will follow submission of additional Phase 3 data.
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.
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 3 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 and Sanofi fulfilled all of its commitments in 2022 and 2023.
Consumer Healthcare
In 2023, the company progressed further in building and simplifying the company’s stand-alone CHC organization. The company has further reduced the company’s portfolio, mainly through divestments, to 117 brands (47% fewer than in 2019). In September 2023 the company announced the completion of the acquisition of QUNOL, a leading U.S. health and wellness brand that strengthens the company’s CHC portfolio in a key market, and within the promising VMS segment.
By the end of 2023, all the CHC legal entities required to establish a standalone organization had been established, except in India, and staffed with dedicated teams. The company’s CHC business now publishes its results as a separate dedicated segment, including all its support function costs, within the Sanofi environment. The company also announced its intention to separate the company’s CHC operations at the earliest in the fourth quarter of 2024, most likely through a capital markets transaction, via the creation of a listed entity headquartered in France.
In line with the company’s high sustainable development ambitions, Sanofi CHC North America achieved B-corp accreditation in July 2023.
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, 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.
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); QUNOL in the U.S. for healthy aging; 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 products for daily hydration, aging skin, cracked skin, overnight nourishment, and specialty skincare needs like eczema-prone skin. GOLD BOND is only sold in the U.S. and Canada.
Global Research & Development
Focusing on its portfolio of 12 new molecular entities, including multiple late-stage assets, Sanofi’s strategy is to prioritize development and leverage its leadership in immunology across all other therapeutic areas.
Products in Development
Products in clinical development include three ‘pipeline-in-a-product’ assets – amlitelimab, frexalimab and the oral TNFR1 signaling inhibitor SAR441566 – intended to address unmet patient needs in markets with low penetration of advanced therapies. In addition, the company’s clinical pipeline features nine innovative medicines and vaccines: tolebrutinib, rilzabrutinib, itepekimab, lunsekimig, the IRAK4 degrader SAR444656, the anti-TL1A monoclonal antibody SAR447189, the ExPEC vaccine, and two mRNA vaccines respectively against respiratory syncytial virus and acne.
Immunology & Inflammation
amlitelimab (SAR445229), a human anti-OX40L monoclonal antibody, is being assessed in clinical programs for the treatment of atopic dermatitis (AD), asthma and hidradenitis suppurativa (HS).
The Phase 2b study (STREAM-AD) in adults with moderate-to-severe AD whose disease cannot be adequately controlled with topical medications or for whom topical medications are not a recommended treatment approach, met its primary endpoint of percentage change in Eczema Area and Severity Index (EASI) score from baseline at 16 weeks. Four subcutaneous doses were studied, and continued improvement was seen through 24 weeks. The Phase 3 program started in 2023 with the first study (Coast 1) initiated for the treatment of participants diagnosed with moderate to severe AD, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
The Phase 2b study (TIDE-asthma) is assessing add-on therapy with amlitelimab in adult participants with moderate-to-severe asthma; results are expected in 2024.
In November 2023, a Phase 2 proof-of-concept study assessing amlitelimab in adult participants with moderate to severe HS was initiated.
Frexalimab (SAR441344), a second generation anti-CD40L monoclonal antibody that blocks the costimulatory CD40/CD40L pathway which is important for activation and function of adaptive (T and B cells) and innate (macrophages/microglia and dendritic cells) immunity. Sanofi is developing frexalimab under an exclusive license from ImmuNext Inc.
Frexalimab is being evaluated in multiple sclerosis (see details in section ‘— c) Neurology’). The compound is also being evaluated in Phase 2 trials for the treatment of Sjogren’s syndrome and systemic lupus erythematosus, respectively. In 2023, a Phase 2b study assessing frexalimab in adults and adolescents with newly diagnosed type 1 diabetes was initiated.
SAR441566, the first small molecule TNFR1 signaling inhibitor, is intended to provide patients with an oral alternative to anti-TNFa monoclonal antibodies in the range of inflammatory indications where these have been approved. SAR441566 is being evaluated in two Phase 2b clinical studies that were initiated in 2023, respectively for the treatment of patients with psoriasis and with rheumatoid arthritis.
itepekimab (SAR440340) is a human anti-IL33 monoclonal antibody co-developed with Regeneron that is being evaluated in a Phase 3 clinical program (AERIFY-1 and AERIFY-2 studies) for the treatment of COPD in former smokers; itepekimab is also being assessed in a cohort of current smokers in AERIFY-2. In addition, an exploratory Phase 2a study (AERIFY-3) is evaluating the mechanism of action of itepekimab and its impact on airway inflammation in former and current smokers with COPD. Itepekimab has FDA Fast Track Designation for the treatment of COPD.
rilzabrutinib (SAR444671) is a covalent and reversible inhibitor of Bruton’s tyrosine kinase under development for the treatment of autoimmune/inflammatory diseases.
The Phase 2 study evaluating rilzabrutinib in adults with moderate-to-severe chronic spontaneous urticaria (CSU) met its primary endpoint consisting of improvement in weekly itch severity score (primary endpoint in the U.S.) or in weekly urticaria activity score (itch and hives; primary endpoint outside the USA). Improvements in secondary endpoints were also observed. The Phase 3 clinical program in CSU will be initiated in 2024. Further Phase 2 studies have been pursued, assessing the product for the treatment of patients with moderate-to-severe asthma and IgG4-related disease, respectively.
In 2023, the development of rilzabrutinib for the treatment of atopic dermatitis was discontinued, based on the results of a Phase 2 study in which the primary endpoint was not met.
In addition, rilzabrutinib is being evaluated for the treatment of immune thrombocytopenia and warm autoimmune hemolytic anemia.
lunsekimig (SAR443765) is a bispecific NANOBODY VHH which blocks both TSLP and IL-13, key upstream and downstream mediators (respectively) of asthma. After Proof-of-Mechanism findings were obtained earlier this year, a Phase 2b study (AIRCULES) enrolled the first participants in 2023.
SAR444656 is a selective, orally administered small molecule targeting Interleukin-1 Receptor Associated Kinase 4 (IRAK4), which is necessary for proinflammatory signaling and cytokine production. SAR444656 is developed in partnership with Kymera Therapeutics. Based on the encouraging results of a Phase 1 clinical trial, Sanofi has initiated two Phase 2 studies, respectively in atopic dermatitis and in HS.
SAR447189 (also known as TEV-48574), an anti-TL1A monoclonal antibody, entered the company’s Immunology & Inflammation portfolio in 2023 and is co-developed with Teva Pharmaceuticals. SAR447189 is being evaluated in a Phase 2 clinical program for the treatment of adults with ulcerative colitis and Crohn’s disease (inflammatory bowel disease).
eclitasertib (SAR443122) is a small molecule targeting the receptor-interacting serine/threonine-protein kinase 1 (RIPK1), which is being co-developed with Denali. In 2023, it was decided to discontinue eclitasertib in cutaneous lupus erythematosus, based on the efficacy results of the proof-of-concept Phase 2 study. The compound was found to be generally well-tolerated and a Phase 2 study evaluating eclitasertib in patients with ulcerative colitis is ongoing.
riliprubart (SAR445088) is a complement C1s inhibitor under clinical development in various indications (see details in section ‘— e) Rare Blood Disorders’ and section ‘— c) Neurology’). A Phase 2 study is evaluating the compound for the treatment of patients at risk of antibody-mediated rejection (AMR) or diagnosed with AMR.
SAR442970, a bispecific NANOBODY VHH that combines the blockade of TNFa and the immune co-stimulatory regulator OX40L progressed to Phase 2 in 2023 for the treatment of Hidradenitis Suppurativa.
SAR444336, a non-beta IL-2 SYNTHORIN molecule designed to selectively engage CD4+ regulatory T cells (and not on effector T or NK cells), is being evaluated in Phase 1 for the treatment of inflammatory indications.
SAR444559, an anti-CD38 monoclonal antibody with engineered format, is in clinical development for the treatment of inflammatory indications.
In 2023, new products originating from Sanofi’s research entered Phase 1 for the treatment of inflammatory indications:
SAR445399, an anti-IL1R3 mAb monoclonal antibody;
SAR445611, an anti-CX3CR1 NANOBODY VHH; and
SAR446422, a bispecific antibody targeting CD28 and OX40.
Oncology
pegenzileukin (SAR444245) is a non-alpha IL-2 SYNTHORIN molecule being evaluated in a Phase 1/2 program initiated in 2023, to optimize the dose schedule for the treatment of solid tumors.
SAR444881, a monoclonal antibody targeting the Ig-like transcript 2 (ILT2) receptor co-developed with Biond Biologics for the treatment of solid tumors, is being evaluated in Phase 1.
SAR445419 is an off-the-shelf NK cell therapy being evaluated in Phase 1 for the treatment of relapsed/refractory acute myeloid leukemia.
SAR443579 is a trifunctional anti-CD123 NK cell engager developed in partnership with Innate Pharma. SAR443579 is being investigated in a Sanofi-sponsored Phase 1/2 clinical trial in patients with relapsed or refractory acute myeloid leukemia, B-cell acute lymphoblastic leukemia or high risk-myelodysplasia. SAR443579 has FDA Fast Track Designation for the treatment of acute myeloid leukemia.
SAR446309, an HER2-based T cell engager, is being evaluated as a single agent and in combination with pembrolizumab, in a Phase 1 clinical trial for the treatment of locally advanced or metastatic HER2-expressing cancers.
SAR444200 is a GPC3-based T cell engager designed with a NANOBODY VHH format that is being evaluated in Phase 1 in patients with advanced solid tumors.
SAR445877 is an anti PD1/IL-15 fusion protein under assessment in a Phase 1 trial in patients with solid tumors.
SAR445514 is a trifunctional anti-BCMA NK cell engager developed in partnership with Innate Pharma for the treatment of relapsed or refractory multiple myeloma; a Phase 1/2 study was initiated in 2023.
SAR445953, an antibody drug conjugate (ADC) that binds to human CEACAM-5, is under Phase 1 clinical evaluation for the treatment of patients with colorectal cancer or other solid tumors. SAR445953 is developed in collaboration with Seagen Inc.
Neurology
tolebrutinib (SAR442168) is an oral investigational brain-penetrant and bioactive Bruton’s tyrosine kinase (BTK) inhibitor that achieves cerebrospinal fluid concentrations predicted to modulate B lymphocytes and microglial cells. Tolebrutinib is being evaluated in Phase 3 clinical trials for the treatment of relapsing forms of multiple sclerosis (RMS), non-relapsing secondary progressive MS (nrSPMS), and primary progressive MS (PPMS).
frexalimab (SAR441344) is a monoclonal antibody against CD40L, a key immune costimulatory component involved in MS. Through its unique upstream mechanism of action, frexalimab has the potential to address both acute and chronic neuroinflammation in MS. Data from the placebo-controlled part of the Phase 2 study data in adults diagnosed with RMS demonstrated significant reductions in new gadolinium-enhancing lesions at week 12 (primary objective), plus sustained reduction of disease activity over week 24 in both high-dose and low-dose frexalimab groups. The treatment continuation open-label part of the study is ongoing. Two Phase 3 studies were initiated late 2023 to evaluate the efficacy and safety of frexalimab for the treatment of adults with RMS and nrSPMS, respectively.
SAR443820 is an oral brain-penetrant RIPK1 inhibitor that targets inflammatory cell signaling and activation of cell death pathways in MS pathophysiology. Its multitargeted mechanism of action and flexibility to be used as a monotherapy or in combination gives the compound the potential to address neurodegeneration and disability accumulation. SAR443820 is in-licensed from Denali and has been evaluated in Phase 2 clinical trials for amyotrophic lateral sclerosis (ALS) and MS. Results of the Phase 2 trial in ALS (HIMALAYA) obtained in February 2024 indicated that the primary endpoint was not met; development of SAR443820 in this indication will not be pursued. Sanofi will continue the Phase 2 study (K2) of SAR443820 in participants with MS.
riliprubart (SAR445088), a complement C1s inhibitor, is being assessed in a Phase 2 trial in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
SAR446159 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 1 study assessing the safety and tolerability of intravenous SAR446159 is ongoing.
Rare Diseases
venglustat (GZ402671) is an orally administered brain penetrant glucosylceramide synthase (GCS) inhibitor that blocks the conversion of ceramide to glucosylceramide (GL-1). Venglustat is being evaluated in Phase 3 trials 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. The data of the Phase 3 study in late-onset GM2 gangliosidosis and subsequent submission are expected in 2024.
SAR442501 is an antibody (Fab format) that directly targets fibroblast growth factor receptor 3 (FGFR3), which has a gain-of-function genetic mutation leading to premature closure of bone growth plates and the achondroplasia condition, the most common cause of dwarfism in the world. In 2023, a Phase 2 clinical trial was initiated to evaluate SAR442501 for the treatment of achondroplasia in children from birth up to 12 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 1 trial for the treatment of rare renal diseases.
SAR439459 is a monoclonal antibody targeting transforming growth factor beta (TGFß) evaluated in a Phase 1 study 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.
SAR444836 is a phenylalanine hydroxylase replacement gene therapy based on adeno-associated virus vector technology that is developed in collaboration with MediciNova, Inc. In 2023, a Phase 1 study was initiated to treat patients with phenylketonuria. Orphan Drug Designation has been granted by the FDA for this indication.
Rare Blood Disorders
rilzabrutinib (SAR444671) is being investigated in a Phase 3 trial for the treatment of adults and adolescents with persistent or chronic immune thrombocytopenia (ITP), for which the FDA has granted Fast Track Designation. Rilzabrutinib is also being evaluated in a Phase 2b study for the treatment of adults with warm autoimmune hemolytic anemia (wAIHA).
fitusiran (SAR439774), a first-in-class, subcutaneously administered antithrombin siRNA therapy, is in Phase 3 clinical development for the treatment of hemophilia A or B, with or without inhibitors, which includes lower doses and less frequent dosing while maintaining an antithrombin target range of 15-35% (antithrombin-based dosing regimen, AT-DR) in all ongoing studies. The Phase 3 open-label extension study (ATLAS-OLE) demonstrated during an interim analysis a substantially improved safety profile versus AT-DR, and the risk of thrombosis was reduced with rates comparable to those reported in the general hemophilia population. Pre-specified efficacy analyses confirmed that fitusiran provides consistent protection with as few as six injections per year. Sanofi is in discussions with the U.S. FDA regarding filing in 2024. Planned submissions in the European Union and Japan will require data from the ongoing Phase 3 ATLAS-NEO study.
riliprubart (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 being evaluated in a Phase 2 study for the treatment of patients with CAD.
Vaccines
The Vaccines R&D portfolio includes projects enhancing existing vaccines, and projects addressing novel targets. As shown below, several projects are in Phase 2 and Phase 3.
mRNA Quadrivalent influenza vaccine (SP0273) is a quadrivalent influenza vaccine based on mRNA technology, which is in Phase 1. Following results of Phase 1, the mRNA influenza vaccine program is being adapted in order to enter Phase 3 with an optimal next generation influenza vaccine.
Rabies Vaccine (SP0087): 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 3 trials in order to support pre and post exposure indications.
Vero Yellow Fever (vYF) vaccine candidate (SP0218) 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 at replacing STAMARIL and YF-VAX with a single product. Following positive Phase 2 results in 2023, Phase 3 will be initiated in 2024.
ExPEC vaccine (SP0282): ExPEC is a vaccine for the prevention of invasive E.Coli disease, including sepsis, which is expected to complement the company’s older adults vaccines portfolio. This 9-valent vaccine is partnered with Janssen Pharmaceuticals Inc., a Johnson and Johnson company; it is in Phase 3, which was initiated in 2021 and continues to enroll patients.
RSV toddler vaccine (SP0125): All infants can be protected against RSV during their first season with BEYFORTUS (nirsevimab), now launched in the U.S. and several other countries. The goal of RSV toddler vaccine is to expand RSV protection by providing protection to all toddlers against RSV, from the second season onwards. Positive data from a Phase 1/2 study performed in the U.S. evaluating the safety and effectiveness of two doses of an intranasal delivery device in infants were obtained at the beginning of 2023, which will enable a move to Phase 3 in 2024.
RSV older adult vaccine (SP0256): Sanofi has initiated Phase 2 with an mRNA vaccine against RSV for the older adults population. This vaccine aims at providing protection against RSV, and is key for a respiratory combination providing additional benefits against other unmet medical needs (hMPV, PIV). Consistent with this, the company started Phase 1/2 in November 2023 with an RSV/hMPV combination vaccine.
Meningococcal Group B (Men B) and MenPenta (Men ACWYB) (SP0230): Sanofi’s MenB vaccine candidate is intended to provide active immunization against invasive meningococcal disease caused by Neisseria meningitidis serogroup B (Men B) for all age groups. Following positive results of a Phase 1/2 study initiated in March 2021, and positive pre-clinical data obtained on MenPenta, a MenPenta Phase 1/2 was initiated in October 2023.
Pneumococcal Conjugate Vaccine (PCV) (SP0202): Sanofi is collaborating with SK Biosciences (South Korea) to develop a 21-valent pneumococcal conjugate vaccine that will provide expanded protection against pneumococcal disease. Data from Phase 2 studies assembled between mid-2022 and mid-2023 will allow the company to move to Phase 3 in the pediatric population in 2024.
Line Extensions
DUPIXENT is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, 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), eosinophilic esophagitis (EoE) or prurigo nodularis (PN) in different age populations; details about clinical and regulatory activities pursued in 2023 are provided below.
DUPIXENT is under assessment for the treatment of dermatology, respiratory and gastrointestinal diseases:
In October 2023, the FDA issued a Complete Response Letter (CRL) for the sBLA for DUPIXENT in CSU, an inflammatory skin condition, which causes sudden and debilitating hives and swelling on the skin. The CRL states that additional efficacy data are required to support an approval; it did not identify any issues with safety or manufacturing. An ongoing Phase 3 clinical trial (Study C) continues to enroll patients, with results expected in late 2024 that are anticipated to provide the additional efficacy data. Sanofi and Regeneron remain committed to working with the FDA to advance the study of DUPIXENT for patients living with CSU who are inadequately controlled by antihistamines.
The primary and all key secondary endpoints were met in the BOREAS Phase 3 trial evaluating DUPIXENT compared to placebo in adults on maximal standard-of-care inhaled therapy (triple therapy) with uncontrolled COPD and evidence of type 2 inflammation. Clinically meaningful and highly significant reduction (30%) in moderate or severe acute exacerbations of COPD (rapid and acute worsening of respiratory symptoms) was obtained, while the trial also demonstrated significant improvements in lung function, quality of life and COPD respiratory symptoms. The second, replicate Phase 3 trial (NOTUS) met its primary endpoint (significant reduction of exacerbations of COPD with DUPIXENT compared to placebo), confirming the results from the BOREAS pivotal trial. Supplemental BLA in the U.S. was completed in December 2023, following Marketing Authorization Application submission in Europe; the respective approvals are expected in 2024.
A Phase 3 clinical study (LIBERTY-BP) is ongoing to evaluate DUPIXENT in adult patients with bullous pemphigoid; results are expected in 2024.
The product is being assessed in a Phase 3 study (LIBERTY-CPUO-CHIC) for the treatment of chronic pruritis of unknown origin in adults.
A Phase 2/3 trial evaluating DUPIXENT in adult and adolescent patients with eosinophilic gastritis with or without eosinophilic duodenitis was initiated in 2023.
A Phase 2 clinical study was initiated in 2023 for the treatment of patients with ulcerative colitis.
The Phase 3 study (LIBERTY-CINDU) evaluating DUPIXENT in chronic inducible cold urticaria did not meet the required efficacy endpoints to continue this program.
Discontinuation of DUPIXENT programs in allergic fungal rhinosinusitis and chronic rhinosinusitis without nasal polyps was decided due to portfolio prioritization; the respective studies will be completed.
KEVZARA, a monoclonal antibody against the IL-6 receptor (developed with Regeneron) is already marketed for the treatment of moderate to severe rheumatoid arthritis.
The product is being developed for the treatment of polyarticular juvenile idiopathic arthritis. Based on the 52-week data of the pivotal Phase 2 study assessing the pharmacokinetic profile, safety, and efficacy of sarilumab in children aged two to 17 years old with polyarticular juvenile idiopathic arthritis, KEVZARA was submitted for approval to the FDA and to the European Medical Agency (EMA), respectively in August and November 2023. The extension of indication is further supported by extrapolation of efficacy data in adults with rheumatoid arthritis to the pediatric population with polyarticular juvenile idiopathic arthritis.
A repeat dose-finding Phase 2 study evaluating KEVZARA in children and adolescents with systemic juvenile idiopathic arthritis (SKYPS) is ongoing in Europe and in the rest of the world, as part of the pediatric investigation plan.
TZIELD is a CD3-directed monoclonal antibody acquired by Sanofi in 2023. TZIELD is the first and only disease modifying therapy in type 1 diabetes (T1D), a chronic autoimmune condition where the body’s ability to regulate blood sugar levels is impacted due to the gradual destruction of insulin producing beta cells by one’s own immune system. The product was approved by the FDA in November 2022 to delay the onset of Stage 3 T1D in adults and children eight years and older diagnosed with Stage 2 T1D.
The potential of TZIELD to slow the progression of Stage 3 T1D in newly diagnosed children and adolescents is being evaluated in a Phase 3 clinical program.
SARCLISA 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. SARCLISA is approved in several countries in combination settings for the treatment of adults with relapsed refractory multiple myeloma (RRMM).
SARCLISA is under assessment in combination with current standard and novel treatments across the MM treatment continuum:
The Phase 3 study (IMROZ) evaluating SARCLISA in combination with standard-of-care bortezomib, lenalidomide and dexamethasone (VRd) met its primary endpoint at a planned interim analysis for efficacy, demonstrating statistically significant improvement in progression-free survival compared with VRd alone in transplant-ineligible patients with newly diagnosed MM. These results will form the basis of a regulatory submission planned in 2024;
A Phase 3 study (IRAKLIA) investigating the development of a new subcutaneous formulation with an on-body device system in RRMM patients who have received at least one prior line of therapy is ongoing; this program is managed in collaboration with Blackstone Life Sciences;
A Phase 3 study (GMMG HDF) is evaluating SARCLISA in combination with lenalidomide, bortezomib and dexamethasone for induction and with lenalidomide for maintenance in patients with newly diagnosed MM. This clinical trial is being conducted in collaboration with the German-speaking Myeloma Multicenter Group (GMMG);
A Phase 3 trial (ITHACA) is assessing SARCLISA in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone in patients with high-risk smoldering MM;
SARCLISA is under evaluation in new combinations with emerging novel mechanisms of action in a Phase 2 study for the treatment of patients with RRMM or newly diagnosed MM patients.
In 2023, the Phase 2 study evaluating SARCLISA in combination with chemotherapy in pediatric patients with relapsed/refractory acute lymphoblastic leukemia or acute myeloid leukemia (ISAKIDS) was terminated.
Finally, the Phase 2 study evaluating the safety, pharmacokinetics and efficacy of subcutaneous SARCLISA in adults with Warm Autoimmune Hemolytic Anemia (wAIHA), a rare blood disorder, was discontinued based on the preliminary results and portfolio prioritization.
REZUROCK is a selective ROCK2 (rho-associated coiled-coil–containing protein kinase-2) inhibitor that is approved 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.
Clinical development of the drug has been pursued in 2023 in two additional indications:
A Phase 3 study is evaluating REZUROCK in combination with corticosteroids for the treatment of newly diagnosed moderate or severe chronic GVHD;
Another Phase 3 study is assessing REZUROCK on top of azithromycin and standard-of-care regimen of immunosuppression in adult participants who have evidence of progressive chronic lung allograft dysfunction (CLAD) despite azithromycin therapy.
NEXVIAZYME 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 for the treatment of patients with Pompe disease, a rare disease caused by a deficiency of the enzyme acid alpha-glucosidase (GAA). In Europe, the treatment is marketed under the brand name NEXVIADYME.
A Phase 3 program is ongoing for the treatment of patients aged six months or younger who are affected by infantile onset Pompe disease.
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 3 trial.
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 two years and over), and in Europe and several other countries (for people aged 12 months and over). MENQUADFI has also received WHO pre-qualification for people aged 12 months and above. Phase 3 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 six weeks of age.
Research and Development (R&D)
Expenditures on research and development amounted to €6,728 million in 2023, comprising €6,509 million in the Biopharma segment and €219 million in the Consumer Healthcare segment.
Within the Biopharma segment, investments in Pharmaceuticals and Vaccines R&D represented respectively €3,816 million and €885 million in 2023, mainly reflecting additional spend in Immunology and reduced spend in investment in oncology (Pharmaceuticals), while Vaccines made further investments in the mRNA vaccines platform. Medical Affairs investment and R&D Support functions came to €2,027 million in 2023, while cost control efforts continued overall.
Markets
The data are mainly from IQVIA MIDAS local sales audit supplemented by various other country-specific sources, including Knobloch (Mexico), GERS (France) and HMR (Portugal).
Marketing and Distribution
The company has business operations in approximately 70 countries and the company’s products are available in more than 180 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.
The company uses a range of channels from in-person to digital to disseminate information about and promote the company’s products among healthcare professionals, ensuring that the channels not only cover the company’s latest therapeutic advances but also the company’s established prescription products, which satisfy patient needs in some therapy areas. The company regularly exhibits at major medical congresses. In some countries, products are also marketed directly to patients by way of television, radio, newspapers and magazines, and digital channels (such as the Internet). National education and prevention campaigns can be used to improve patients’ knowledge of their conditions.
The company’s sales representatives, who work closely with healthcare professionals, use their expertise to promote and provide information on the company’s drugs.
Although the company markets most of its products through the company’s own sales forces, the company has entered into and continue to form partnerships to co-promote/co-market certain products in specific geographical areas.
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 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 CHC 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).
The company’s industrial property rights, patents and trademarks are mainly held by the following companies:
Biopharma: Sanofi, Sanofi Mature IP, Sanofi Biotechnology SAS (France), Sanofi-Aventis Deutschland GmbH (Germany), Ablynx (Belgium), Genzyme Corporation, Bioverativ Inc., Kadmon Corporation LLC, Amunix Pharmaceuticals, Inc., Kymab Ltd, Principia Biopharma Inc., Sanofi Pasteur (France), Sanofi Pasteur, Inc. (U.S.), Sanofi Pasteur Vaxdesign Corp., Translate Bio (U.S.), Synthorx, Inc., Aventis Pharma SA and Provention Bio, Inc.;
Consumer Healthcare: A. Nattermann Cie & GmbH (Germany), Chattem Inc. (U.S.), Opella Healthcare and SSP Co. Ltd (Japan).
The company’s property, plant and equipment is held mainly by the following companies:
In France: Sanofi Pasteur SA, Sanofi Chimie, Sanofi Winthrop Industrie, Opella Healthcare International SAS and Sanofi-Aventis Recherche & Developpement;
In the United States: Sanofi Pasteur, Inc., Genzyme Therapeutics Products LP, Genzyme Corporation and Translate Bio;
In Germany: Sanofi-Aventis Deutschland GmbH;
In Canada: Sanofi Pasteur Limited;
In Belgium: Genzyme Flanders BVBA; and
In Ireland: Genzyme Ireland Limited.
History
The company was founded in 1973. It was incorporated under the laws of France in 1994. The company was formerly known as Sanofi-Aventis and changed its name to Sanofi in 2011.
