For Sanofi, investment in mRNA technology, immuno-oncology and corporate social responsibility are all part of the company’s “Play to Win” strategy.

 

Sanofi

54, Rue La Boétie

75008 Paris, France

Telephone: +33 (0)1 53 77 46 46

Website: sanofi.com

 

 

OUTCOMES CREATIVITY INDEX SCORE: 24

Manny Awards — 2 

Cannes Lions — N/A

Clio Health — 9

Creative Floor Awards — 8

MM+M Awards — 4 

One Show — 1 

 

Financial Performance

(All figures except EPS are in millions of dollars and were translated using the Federal Reserve Board’s average rate of exchange in 2020: €1.141)

2020  

Revenue $41,123  

Net income $14,050  

Diluted EPS $11.15  

R&D expense $6,309  

1H 2021  

Revenue $19,779  

Net income $3,190 

Diluted EPS $2.52 

R&D expense $3,038  

 

Best-Selling Products

(All sales are in millions of dollars and were translated using the Federal Reserve Board’s average rate of exchange in 2020: €1.141)

2020  

Dupixent $4,032  

Lantus $3,036  

Aubagio $2,333  

Lovenox $1,541  

Myozyme, Lumizyme  $1,082  

Toujeo $1,065  

Plavix $1,045  

Fabrazyme $932  

Cerezyme $787  

Eloctate $728  

Avapro/Aprovel, CoAprovel $632 

Jevtana $612 

1H 2021  

Dupixent $2,613  

Lantus $1,471  

Aubagio $1,134   

Lovenox $876  

Toujeo $571 

Plavix $553  

Myozyme/Lumizyme $551 

Fabrazyme $470  

Cerezyme $391  

Eloctate $317  

Jevtana $274  

 

“The pandemic has forced us to question some of the fundamentals of our modern society: how we live and work, but also how we connect with our ecosystems and each other,” Hudson says. “COVID-19 by itself will not change the world. But our response to it will.” — CEO Paul Hudson

2020 will be remembered as a challenging and tragic year for the world and the millions of people impacted by the novel coronavirus,” states Paul Hudson, CEO of Sanofi. “Yet as challenging as last year was, it also brought us – Sanofi and the pharmaceutical industry – closer to our purpose than any time in living memory.”

According to Hudson, while the pandemic forced the company to think and act for the short term, Sanofi did not lose track of its long-term goal and ambition of changing the practice of medicine. “Measurable and important progress has indeed been made in advancing the company’s strategy, taking us closer to bringing breakthrough medicines and vaccines to people who need them,” Hudson says.

Additionally, 2020 was also the year during which Sanofi reviewed and rethought its Corporate Social Responsibility strategy, or what Hudson calls “our new contract with society”.

“The ambitions of this new strategy have been fully aligned to and embedded in our Play to Win strategy,” Hudson says. “The flagship initiatives that will be rolled out in 2021 have a common objective: make our mark where we can and where we are uniquely positioned to do so, to make a meaningful and long-lasting difference.”

The Play to Win Strategy involves major decisions and positive actions that executives say will support and rebuild the competitive margins necessary for Sanofi to continue to deliver on its mission. The strategy is based on four major priorities: focusing on growth, leading with innovation, accelerating efficiency, and reinventing how the company works.

“The pandemic has forced us to question some of the fundamentals of our modern society: how we live and work, but also how we connect with our ecosystems and each other,” Hudson says. “COVID-19 by itself will not change the world. But our response to it will.”

There are four flagship programs that will be embedded in Sanofi’s Corporate Social Responsibility as part of its Play to Win strategy: Affordable Access; R&D for Unmet Needs; Efficiency and Sustainability; and Beyond the Workplace.

Through Affordable Access, Sanofi plans to create a Global Health Unit that gives access and supply continuity to 30 essential medicines at no profit to the 40 poorest countries; donate 100,000 vials to treat rare disease patients free of charge; and develop a global access plan for all new products with the goal of making new innovations available within two years.

In R&D for Unmet Needs, the goals are to eradicate polio; eradicate sleeping sickness in humans by 2030; and develop innovative medicines to eliminate cancer deaths in children. 

The Efficiency & Sustainability goals include 100 percent blister-free vaccines by 2027; eco-design for 100 percent of new products by 2025; 100 percent renewable electricity in all company sites by 2030; and a 100 percent carbon-neutral car fleet by 2030.

And in the Beyond the Workplace strategy, the plans are to have senior leadership representative of society by 2025; social and economic engagement in all communities where the company operates; and embedding corporate social responsibility in leaders’ career development path.

Performance & Outlook

In 2020, Sanofi recorded sales of €36.04 billion ($41.12 billion), slightly less than in 2019. Net income was €12.31 billion ($14.05 billion) compared with €2.81 billion ($3.2 billion) in the previous year. Diluted earnings per share were €9.77 ($11.15) compared with €2.23 ($2.54) one year earlier. The boost in net income and earnings per share were because of the divestment of the Animal Health Business in 2020.

First-half 2021 revenue was €17.34 billion ($19.78 billion), about one percent more than in first-half 2020. Net income was €2.8 billion ($3.19 billion) compared with €9.3 billion ($10.61 billion) in the same period last year. Diluted earnings per share were €2.21 ($2.52) compared with €7.38 ($8.42).

Sanofi operates in three business segments: Pharmaceuticals, Vaccines, and Consumer Health. The Pharmaceuticals segment in 2020 generated €25.67 billion ($29.29 billion), about the same as in 2019. 

The Vaccines Global Business Unit generated €5.97 billion ($6.82 billion), 4.2 percent more than in the previous year. The company’s influenza vaccine franchise generated €2.47 billion ($2.82 billion) mark, responding to public health needs with differentiated flu products, according to management. 

The Consumer Healthcare Global Business Unit recorded sales of €4.39 billion ($5.01 billion), 6.4 percent less than in 2019. Sanofi made two moves to streamline the portfolio of this business in 2021. In June, as part of Sanofi’s ongoing efforts to reduce the complexity of its Consumer Healthcare portfolio and accelerate the growth trajectory, the company signed an agreement with STADA for the divestiture of 16 Consumer Healthcare products commercialized in Europe. Company executives say the transaction with STADA ensures that these products will continue to be available to consumers.

“As discussed during our Capital Markets Day in February, simplifying the CHC product portfolio is an important part of our strategy to focus our resources and efforts where we can bring the most value, especially to consumers. We are pleased these products will continue to be available for consumers as we focus on becoming a fully integrated standalone business,” says Julie Van Ongevalle, executive VP, Sanofi and head of Sanofi Consumer Healthcare.

The agreement covers the registrations, trademarks, and related commercial rights of 16 products across Europe. The transaction is expected to close in the third quarter of 2021. 

In July 2021, Sanofi did a similar divestiture in South America to Hypera SA. This transaction, which involves eight brands, is expected to close at the end of the year.

Sanofi also operates two other business units, the Specialty Care and General Medicines global business units. Specialty Care sales increased 19.5 percent in 2020 to €10.95 billion ($12.5 billion). Sales for the General Medicines unit, which includes established medications, fell 11 percent to €14.72 billion ($16.8 billion).

Dupixent became Sanofi’s N0. 1 product in 2020, reaching €3.53 billion in sales ($4.03 billion), at a growth rate of 70.4 percent. For the first half of 2021, sales of the monoclonal antibody for allergic diseases were €2.29 billion ($2.61 billion), 40.1 percent more than in the first half of 2020.

The long-acting insulin product Lantus was Sanofi’s second best-selling product in 2020, but sales slipped 11.7 percent to €2.66 billion ($3.04 billion).

Lantus was the company’s second best-selling product in 2020. The long-acting insulin delivered sales of €2.66 billion ($3.04 billion), 11.7 percent less than in 2019. First-half 2021 sales declined 9.9 percent from the same period last year, to €1.29 billion ($1.47 billion).

At No. 3 was the oral multiple sclerosis drug Aubagio, which registered €2.05 billion ($2.33 billion), 8.8 percent more than in 2019. But sales in the first half of 2021 were €994 million ($1.13 billion), 6.9 percent less than in first-half 2020.

Coming in as the fourth best-selling product in 2020 was the blood thinner Lovenox at €1.35 billion ($1.54 billion), about the same as in 2019. Sales in the first half of 2021 were €768 million ($876 million), 21.9 percent more than in the same period last year.

Fifth in 2020 sales were the Pompe disease therapies Myozyme and Lumizyme, which generated €948 million ($1.08 billion), 3.3 percent more than in the previous year. Sales in first-half 2021 rose 2.3 percent to €483 million ($551 million).

Sanofi’s sixth best-selling drug last year was the long-acting insulin Toujeo, at €933 million ($1.06 billion), an increase of 5.7 percent from the previous year. The drug had sales of €500 million ($571 million) in the first half of this year, about the same as first-half 2020.

Coming in at No. 7 in 2020 sales was the blood thinner Plavix at €916 million ($1.05 billion), compared with €1.33 billion ($1.52 billion) in 2019. First-half 2021 sales were €485 million ($553 million), 2.3 percent more than in the same period last year.

The Fabry disease drug Fabrazyme came in at eighth in 2020 sales, at €817 million ($932 million), about the same as in the previous year. Sales in the first half of this year were €412 million ($470 million), about the same as in first-half 2020.

Cerezyme, for the treatment of Type 1 Gaucher disease, was next in sales last year, generating €690 million ($787 million), 2.5 percent less than in 2019. Sales in the first half of 2021 were €343 million ($391 million), a decrease of 6.8 percent compared with the same period last year.

Eloctate was the 10th best-selling drug in 2020, with €638 million ($728 million), 6.7 percent less than in 2019. The antihemophilic factor recorded sales of €278 million ($317 million) in the first half of this year, 15.8 percent less than in the first half of 2020.

Sanofi’s other product generating more than $500 million in 2020 sales was the prostate cancer drug Jevtana, recording €536 million ($612 million), 10.7 percent more than in 2019. First-half 2021 sales were €240 million ($274 million) compared with €271 million ($309 million) in the same period last year.

Acquisitions Boost Pipeline 

According to executives, Sanofi is ahead of its plans for growth, efficiencies and cutting-edge science in its pipeline. “Since announcing our new strategy in December 2019, we have been relentless in accelerating our R&D efforts,” Hudson says. “We bolstered our R&D pipeline with the completion of the Synthorx and Principia acquisitions, met several regulatory milestones, and have seen several proofs of concept which reassure us about the priorities we chose.”

Company leaders believe that Sanofi’s work in immunology has the potential to transform patient care in dermatology, respiratory, and a range of autoimmune diseases. “The reshaping of our General Medicines and Consumer Healthcare business units will also enable both to become even more significant contributors to Sanofi’s growth and profitability,” Hudson says.

As many as 12 projects entered Phase III trials in 2020, all of them in Specialty Care. “These are the results of our strategy to prioritize and accelerate our portfolio of potentially transformative therapies,” Hudson says. 

Sanofi achieved this by actually spending less in 2020 on R&D than 2019: €5.53 billion ($6.31 billion) compared with €6.02 billion ($6.87 billion). The decrease was mainly due to cost control, and to a reduction in R&D expenses in diabetes and cardiovascular diseases. However, R&D expenditures in the Vaccines segment rose by 8.3 percent in 2020. 

In oncology, Sanofi’s Phase III trial of amcenestrant in breast cancer enrolled its first patients. In immunology, the company started a Phase III trial for itepekimab in COPD. Tolebrutinib, a brain-penetrant BTK inhibitor, entered four Phase III trials in 2020 in multiple sclerosis.

In Vaccines, one of Sanofi’s key growth drivers, the company expanded its existing collaboration with Translate Bio in order to develop mRNA vaccines across all areas of infectious disease. 

“The expansion of this agreement will further unite Translate Bio’s expertise and knowledge from more than 10 years of mRNA R&D with Sanofi’s leadership in vaccine R&D,” Hudson says.

In fact, this collaboration led to an announcement in August 2021 that Sanofi was acquiring Translate Bio. In the deal, Sanofi acquired all outstanding shares of Translate Bio for $38 per share in cash, which represents a total equity value of approximately $3.2 billion (on a fully diluted basis). The Sanofi and Translate Bio boards of directors unanimously approved the transaction. The acquisition was completed in September 2021, with Translate Bio becoming an indirect, wholly owned subsidiary of Sanofi.

“Translate Bio adds an mRNA technology platform and strong capabilities to our research, further advancing our ability to explore the promise of this technology to develop both best-in-class vaccines and therapeutics,” Hudson says. “A fully owned platform allows us to develop additional opportunities in the fast-evolving mRNA space. We will also be able to accelerate our existing partnered programs already under development. Our goal is to unlock the potential of mRNA in other strategic areas such as immunology, oncology, and rare diseases in addition to vaccines.”

There are two ongoing mRNA vaccine clinical trials under the collaboration, the COVID-19 vaccine Phase I/II study with results expected in Q3 2021 and the mRNA seasonal influenza vaccine Phase I trial with results due in Q4 2021. The acquisition builds on Sanofi’s establishment of a first-of-its kind vaccines mRNA Center of Excellence.

This is not the only acquisition Sanofi made in 2021 in the mRNA arena. In April, the company snapped up Tidal Therapeutics, a privately owned, preclinical-stage biotech company with a novel mRNA-based approach for in vivo reprogramming of immune cells. The technology platform is expected to expand Sanofi’s research capabilities in both immuno-oncology and inflammatory diseases, and may have applicability to other disease areas as well. Sanofi acquired Tidal Therapeutics for an upfront payment of $160 million and up to $310 million upon achievement of certain milestones.

“We anticipate that this next generation, off-the-shelf approach has the potential to bring CAR-T cell therapy to a much broader patient population,” says Frank Nestle, global head of research and chief scientific officer at Sanofi. “With further development, we believe that the underlying mRNA targeting platform has the potential to create disruptive therapeutic approaches for wide-scale adoption as we work to improve patient outcome across a variety of oncology and autoimmune conditions.”

The Tidal Therapeutics acquisition brought a novel mRNA-based approach to in vivo reprogramming of immune cells, based on proprietary nanoparticles that deliver mRNA (messages) to reprogram immune cells inside the body. The technology delivers mRNA cargos selectively to designated types of cells in the body, with initial applications targeting specific types of immune cells. The in vivo approach is designed to provide similar efficacy to current ex vivo (outside the body) approaches where immune cells are genetically modified to enhance their therapeutic properties (such as chimeric antigen receptor CAR-expressing T-cells), with the potential for improved safety, outpatient dosing, and repeat dosing. 

Sanofi established its mRNA Center of Excellence in July 2021, planning to invest about €400 million annually. The Center of Excellence gathers together about 400 dedicated employees integrating end-to-end mRNA vaccine capabilities with dedicated R&D, digital, and chemistry, manufacturing and controls (CMC) teams across sites at Cambridge, Mass., and Marcy l’Etoile, Lyon, France.

“During the COVID-19 pandemic, mRNA technologies demonstrated potential to deliver new vaccines faster than ever before,” says Jean-Francois Toussaint, global head of research and development, Sanofi Pasteur. “However, key areas of innovation such as thermostability and tolerability improvements will be critical to unlock the applications of mRNA in routine vaccination against a broader set of infectious diseases and across all ages. The Sanofi mRNA vaccines Center of Excellence aims to lead the field in this next chapter of vaccine innovation.”

But mRNA technology has not been the only focus of Sanofi’s acquisitions. In September, the company announced it had entered a definitive merger agreement with Kadmon Holdings Inc., a biopharmaceutical company that discovers, develops and markets transformative therapies for disease areas of significant unmet medical needs. The acquisition supports Sanofi’s strategy to continue to grow its General Medicines core assets and will immediately add Rezurock (belumosudil) to its transplant portfolio. 

Rezurock is a recently FDA-approved, first-in-class treatment for chronic graft-versus-host disease (cGVHD) for adult and pediatric patients 12 years and older who have failed at least two prior lines of systemic therapy.

Shareholders of Kadmon common stock will receive $9.50 per share in cash, which represents a total equity value of $1.9 billion (on a fully diluted basis). The Sanofi and Kadmon boards of directors unanimously approved the transaction, which is expected to close in the fourth quarter of 2021.

“We are transforming and simplifying our General Medicines business and have shifted our focus on differentiated core assets in key markets,” says Olivier Charmeil, executive VP, General Medicines. “We are thrilled to add Kadmon’s Rezurock to our well-established transplant portfolio. Our existing scale, expertise, and relationships in transplant create an ideal platform to achieve the full potential of Rezurock, which will address the significant unmet medical needs of patients with chronic graft-versus-host disease around the world.”

Sanofi’s transplant business mainly consists of Thymoglobulin (anti-thymocyte globulin), a polyclonal, anti-human thymocyte antibody preparation that acts as a broad immunosuppressive and immunomodulating agent and Mozobil (plerixafor), a hematopoietic stem cell mobilizer. Both products are among the company’s General Medicines core assets and are registered and marketed in more than 65 countries. 

Kadmon’s pipeline includes drug candidates for immune and fibrotic diseases as well as immuno-oncology therapies. 

In April, Sanofi completed its acquisition of Kiadis Pharma N.V., a clinical-stage biopharmaceutical company developing next generation, “off-the-shelf,” NK cell-therapies.

Kiadis’ proprietary platform is based on allogeneic or “off-the-shelf” NK-cells from a healthy donor. NK-cells seek and identify malignant cancer cells and have broad application across various tumor types. Executives say the platform has the potential to make products rapidly and economically available for a broad patient population across a wide range of liquid and solid tumors, and create synergies with Sanofi’s immuno-oncology pipeline. The acquisition continues to build on Sanofi’s emerging presence in immuno-oncology aligned with the company’s strategy to pursue best-in-class treatments in defined areas.

Sanofi completed another acquisition in April, picking up Kymab Group Ltd. The acquisition adds KY1005 to its pipeline. The drug is a fully human monoclonal antibody targeting key immune system regulator OX40L. Kymab’s pipeline also includes the oncology asset KY1044, an ICOS agonist monoclonal antibody in early Phase I/II development as monotherapy and in combination with an anti-PD-L1.

Sanofi & COVID-19

Like many other pharma companies in 2020 and 2021, Sanofi has been developing a COVID-19 vaccine. In May 2021, Sanofi and GSK (see profile on page 45) started enrollment in their Phase III clinical study to assess the safety, efficacy, and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate. The global, randomized, double-blind placebo-controlled Phase III study will include more than 35,000 volunteers aged 18 and older from several countries, including sites in the United States, Asia, Africa, and Latin America.

The primary endpoint of the study is the prevention of symptomatic COVID-19 in SARS-CoV-2 naïve adults, with secondary endpoints being the prevention of severe COVID-19 disease and prevention of asymptomatic infection. In a two-stage approach, the study will initially investigate the efficacy of a vaccine formulation targeting the original D.614 virus (Wuhan), while a second stage will evaluate a second formulation targeting the B.1.351 (South African) variant. Recent scientific evidence shows that antibodies created against the B.1.351 variant may provide broad cross-protection against other more transmissible variants. The design of the Phase III, conducted across a broad diversity of geographies, also allows evaluation of the efficacy of the candidate against a variety of circulating variants.

Following encouraging interim results from the recent Phase II study, the companies will also begin clinical studies to assess the ability of the adjuvanted recombinant-protein COVID-19 vaccine candidate to generate a strong booster response regardless of initial vaccine platform received.

“We are encouraged to see first vaccinations starting to take place in such an important, pivotal Phase III study, as we believe that our unique technology platform will provide a clinically-relevant vaccine option” says Thomas Triomphe, executive VP, global head of Sanofi Pasteur. “We have adapted our vaccine development strategy based on forward-looking considerations as the virus continues to evolve, as well as anticipating what may be needed in a post-pandemic setting. This trial is testament to the urgency and agility in our approach to help overcome the ongoing impact of this pandemic.

The Phase III study follows the interim Phase II results which showed that the adjuvanted recombinant COVID-19 vaccine candidate achieved high rates of neutralizing antibody responses in all adult age groups, with 95 to 100 percent seroconversion rates. After a single injection, high neutralizing antibody levels were also generated in participants with evidence of prior SARS-CoV-2 infection, suggesting strong potential for development as a booster vaccine. Pending positive Phase III outcomes and regulatory reviews, the vaccine could be approved and authorized in the fourth-quarter 2021. Manufacturing will enable rapid access to the vaccine should it be approved.

In April, Sanofi entered into an agreement with Moderna, under which Sanofi will help manufacture Moderna´s COVID-19 vaccine, supporting the COVID-19 pandemic and vaccine supply needs.

Sanofi is leveraging its established infrastructure and manufacturing expertise at its site in Ridgefield, N.J., to perform fill and finish of up to 200 million doses of Moderna’s COVID-19 vaccine, starting in September 2021.

“Since the beginning of the pandemic, we have been mobilizing on multiple fronts and we showed solidarity across the industry,” Hudson says. “We are one of the few pharmaceutical companies to leverage many industrial partnerships to improve global supply and access to COVID-19 vaccines, while in parallel, also continuing to develop our two COVID-19 vaccine programs. I would also like to acknowledge the contributions of the Department of Health and Human Services, and the Biden administration, to facilitate this new partnership. ”

This marks Sanofi’s third commitment to provide manufacturing support. Earlier this year, Sanofi announced that the company will provide support to BioNTech for 125 million doses for the European Union. In February, Sanofi announced one of the company’s manufacturing sites in France would support Johnson & Johnson for the production of its COVID-19 vaccine at a rate of 12 million doses per month. Sanofi is the only large manufacturer to support all three vaccine efforts.

Pipeline Progress

Sanofi continues to advance its pipeline in other areas. The company received FDA approval of Nexviazyme in August for the treatment of treatment of patients 1 year of age and older with late-onset Pompe disease. Nexviazyme is an enzyme replacement therapy (ERT) designed to specifically target the mannose-6-phosphate (M6P) receptor, the key pathway for cellular uptake of enzyme replacement therapy in Pompe disease. Nexviazyme has been shown in clinical trials to provide patients with improvements in respiratory function and walking distance.

“Pompe disease is a debilitating and progressive condition that significantly inhibits mobility and breathing,” says Bill Sibold, executive VP of Sanofi Genzyme. “For decades, we’ve made it our responsibility to research how to target the M6P receptor, the key pathway for cellular uptake of enzyme replacement therapy. Nexviazyme is a potential new standard of care for people living with late-onset Pompe disease and delivers on our promise to pursue medicines for patients living with rare diseases.”

Pompe disease affects an estimated 3,500 people in the United States. The condition can present as infantile-onset Pompe disease (IOPD), the most severe form of Pompe disease with rapid onset in infancy, and late-onset Pompe disease (LOPD), which progressively damages muscles over time. LOPD symptoms may present at any age. However, due to the wide spectrum of clinical presentations and progressive nature of the disease, it can take seven to nine years before patients receive an accurate diagnosis. As the disease progresses, people with LOPD may require mechanical ventilation to help with breathing or a wheelchair to assist with mobility.

As part of the company’s commitment to ensure treatment access and affordability for innovative therapies, Sanofi has decided to price Nexviazyme the same as alglucosidase alfa, the only other FDA-approved therapy for the treatment of Pompe disease and the comparator arm in the pivotal COMET study.

More good news for Sanofi’s pipeline also came in August, when the Phase III trial of Libtayo in combination with platinum-doublet chemotherapy was stopped early after meeting its overall survival (OS) primary endpoint in patients with advanced non-small cell lung cancer (NSCLC). The PD-1 inhibitor is being jointly developed by Sanofi and Regeneron Pharmaceuticals Inc.

The decision to stop the trial early was based on a recommendation by the Independent Data Monitoring Committee (IDMC) during a protocol-specified interim analysis. In this top-line initial analysis of 466 patients, combining Libtayo with chemotherapy reduced the risk of death by 29 percent compared to chemotherapy alone (hazard ratio: 0.71; 95 percent confidence interval CI: 0.53-0.93; p=0.014). Median OS was 22 months (95 percent CI: 16 months to not evaluable) for Libtayo and chemotherapy, and 13 months (95 percent CI: 12 to 16 months) for chemotherapy alone. The randomized, multicenter Phase III trial, called EMPOWER-Lung 3, investigated a first-line combination treatment of Libtayo and platinum-doublet chemotherapy, compared to platinum-doublet chemotherapy alone, in squamous or non-squamous advanced NSCLC irrespective of PD-L1 expression.

In May, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for Libtayo as monotherapy in two advanced cancers. The CHMP recommended the approval of Libtayo for the first-line treatment of adults with non-small cell lung cancer (NSCLC) expressing PD-L1 in ≥50% of tumor cells with no EGFR, ALK or ROS1 aberrations. Patients must have metastatic disease or locally advanced disease that is not a candidate for definitive chemoradiation. Libtayo was also recommended for approval in adults with locally advanced or metastatic basal cell carcinoma (BCC) who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI). The European Commission is expected to make a decision on both indications in the coming months.

In March, the Phase III trial of Libtayo monotherapy in advanced cervical cancer was also stopped early for positive result on overall survival.

Libtayo was approved in February by FDA for patients with first-line advanced non-small cell lung cancer with PD-L1 expression of ≥50 percent. This was the third approval for Libtayo and followed a Priority Review by the FDA. Earlier in February, Libtayo was approved as the first immunotherapy indicated for patients with advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate, with full approval granted for locally advanced disease and accelerated approval granted for metastatic disease. In 2018, Libtayo was the first systemic treatment approved for adults with advanced cutaneous squamous cell carcinoma (CSCC) that is locally advanced or metastatic and who are not candidates for curative surgery or curative radiation.   

In July, Sanofi received FDA approval for fexinidazole as the first all-oral treatment for sleeping sickness. Fexinidazole was developed as part of an innovative partnership between the non-profit research and development organization Drugs for Neglected Diseases initiative (DNDi), which conducted the pivotal clinical trials for this treatment, in partnership with the National Sleeping Sickness Programs of the Democratic Republic of Congo (DRC) and Central African Republic (CAR), and Sanofi. 

Current treatment options for the disease are effective, but burdensome for patients and health workers due to the need for infusion or injection, requiring hospitalization, especially challenging for people living in remote areas.

“This FDA approval is a key milestone in Sanofi’s long-term commitment to fight sleeping sickness, started 20 years ago alongside the WHO through an ambitious partnership to combat Neglected Tropical Diseases” says Luc Kuykens, senior VP, Sanofi Global Health unit. “Following the positive scientific opinion granted by the European Medicines Agency in 2018, the FDA approval is an important step to revitalize efforts to support the sustainable elimination of the disease.”

As a result of FDA marketing approval, a Tropical Disease Priority Review Voucher (PRV) has been awarded to DNDi. The FDA Tropical Disease PRV Program was established during 2007 to incentivize development of new treatments for neglected tropical diseases, including sleeping sickness. Any benefits from the PRV will be shared between Sanofi and DNDi, which will enable continued investments in innovating for and ensuring access to new health tools for sleeping sickness and other neglected diseases. Sanofi commits to continue to provide the drug free-of-charge to the World Health Organization for distribution to affected countries, as part of a long-term collaboration with WHO.

In Sanofi’s diabetes pipeline, the company in June 2021 announced new data that shows Soliqua offers improved blood sugar control without weight gain compared with premixed insulin.

The study met its two primary endpoints and all key secondary endpoints in a head-to-head comparison against premixed insulin (biphasic insulin aspart 30, BIAsp 30) in adults living with type 2 diabetes, the most common form of diabetes, uncontrolled on insulin and one or two oral anti-diabetic medicines. The findings were presented at the American Diabetes Association (ADA) 81st Scientific Sessions and simultaneously published in Diabetes Care.

The study met both primary endpoints with Soliqua demonstrating noninferiority of blood sugar (HbA1c) reduction and superiority on body weight change from baseline compared to premixed insulin. The study also met its key secondary endpoints with Soliqua achieving a greater proportion of people reaching a HbA1c target of <7 percent without weight gain, a greater proportion of people reaching a HbA1c target of <7 percent without weight gain and without hypoglycemia, and superiority in reduction of HbA1c compared with those using premixed insulin.

“While premixed is used by around 40 percent of people taking insulin globally to manage their type 2 diabetes today, recent real-world evidence suggests only 18.2 percent of people using it reach their blood sugar goal,”says Sandra Silvestri, M.D., Ph.D., global medical head of General Medicines at Sanofi. “Today’s results provide further information on Soliqua’s impact and patient-reported outcomes that could be considered by healthcare providers in regions such as India, China, the Middle East and North Africa, where premix is widely used.”

Also in June, the company announced positive topline results from the Phase II/III MEDLEY trial for nirsevimab, where the drug showed a similar safety and tolerability profile compared to palivizumab when administered to preterm infants or those with chronic lung disease (CLD) or congenital heart disease (CHD) entering their first respiratory syncytial virus (RSV) season.

MEDLEY is the third pivotal trial to report positive data for nirsevimab. In April, Sanofi reported that nirsevimab met its primary endpoint of achieving a statistically significant reduction of LRTI caused by RSV in healthy preterm and term infants in the Phase III MELODY trial. According to management, coupled with recently published Phase IIb trial results, MELODY and MEDLEY results are part of a robust body of evidence demonstrating the potential of nirsevimab to provide RSV protection to all infants. Results from the MELODY and MEDLEY trials will be presented at forthcoming scientific congresses and, along with the Phase IIb results, will form the basis of global regulatory submissions planned for 2022. Nirsevimab is being developed in partnership with AstraZeneca, and is the first investigational extended half-life monoclonal antibody (mAb) aiming to protect all infants entering their first RSV season, when they are at highest risk for severe RSV disease.

In another advance for its oncology pipeline, Sanofi received approval in March 2021 of Sarclisa (isatuximab) in combination with carfilzomib and dexamethasone (Kd), for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy.

This marks the second FDA approval for Sarclisa, which is also approved in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adults with RRMM who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

“Treatment of patients with relapsed or refractory multiple myeloma remains challenging and the prognosis for patients experiencing multiple relapses unfortunately is poor,” saysPeter C. Adamson, M.D., global development head, Oncology and Pediatric Innovation at Sanofi. “With this approval, Sarclisa is now included in two standard of care regimens for the treatment of patients with multiple myeloma as early as first relapse. Today’s milestone further supports our ambition for Sarclisa to become the anti-CD38 of choice for patients with relapsed or refractory multiple myeloma.”

The anti-inflammatory monoclonal antibody Dupixent was Sanofi’s best-selling drug in 2020, growing 70.4 percent to €3.53 billion ($4.03 billion).

For Sanofi’s best-selling product, in March FDA accepted for review the supplemental Biologics License Application (sBLA) for Dupixent as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. Dupixent is approved as an add-on treatment for patients with uncontrolled moderate-to-severe asthma aged 12 and older with elevated eosinophils or oral corticosteroid dependent asthma. The target action date for the FDA decision is October 21, 2021.