Sales growth accelerated - Full-year guidance raised

Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (definition in Appendix 9)
(1) In order to facilitate an understanding of operational performance, Sanofi comments on the business net income statement. Business net income is a non-GAAP financial measure (definition in Appendix 9). The consolidated income statement for Q2 2021 is provided in Appendix 3 and a reconciliation of reported IFRS net income to business net income is set forth in Appendix 4; (2) 2020 restated business EPS was €5.86; (3) Free cash flow is a non-GAAP financial measure (definition in Appendix 9).

2021 second-quarter and first-half Sanofi sales

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Unless otherwise indicated, all percentage changes in sales in this press release are stated at CER¹

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In the second quarter of 2021, Sanofi sales were €8,744 million, up 6.5% on a reported basis. Exchange rate movements had a negative effect of 5.9 percentage points, mainly driven by the decrease of the U.S. dollar, Japanese yen, Turkish lira, and Argentine peso. At CER, Sanofi sales increased 12.4%.

First-half Sanofi sales reached €17,335 million, up 0.9% on a reported basis. Exchange rate movements had a negative effect of 6.3 percentage points. At CER, Company sales were up 7.2%.

Global Business Units 

Second-quarter 2021 operating income

Second-quarter business operating income (BOI) increased 5.5% to €2,265 million. At CER, BOI increased 13.8%. The ratio of BOI to net sales decreased 0.2 percentage points to 25.9% (26.5% at CER). First-half BOI increased 4.7% to €4,903 million. At CER, BOI increased 13,6%. The ratio of business operating income to net sales increased 1 percentage points to 28.3% (28.9% at CER). 

Pharmaceuticals

Second-quarter 2021 Pharmaceutical sales increased 11.9% to €6,633 million, driven by a 22.0% growth of the Specialty Care portfolio sustained by the strong performance of Dupixent^® while sales in General Medicines grew 4.2%. This performance also reflected the low base in the second quarter of 2020 where the impact of COVID-19 was compounded by the reversal of the stocking effect seen in the first quarter of 2020. First-half Pharmaceuticals sales increased 7.7% to €13,196 million reflecting the strong performance of Specialty Care. 

Specialty Care

Dupixent

In the second quarter, Dupixent^® (collaboration with Regeneron) sales increased 56.6% to €1,243 million. In the U.S., Dupixent^® sales of €947 million (up 48.9%) were driven by continued strong demand in atopic dermatitis (AD) in adults, adolescents, and children aged 6 to 11 years, and continued uptake in asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP). Dupixent^® total prescriptions (TRx) increased 50% (year-over-year) and new-to-brand prescriptions (NBRx) grew 52% despite fewer in-person physician visits, which remain below the pre-COVID level. In Europe, second-quarter Dupixent^® sales grew 79.8% to €152 million reflecting continued growth in AD in key countries and additional launches in asthma in European markets. In Japan, sales were €69 million (up 71.1%). First half Dupixent^® sales reached €2,290 million, up 51.4%. At the end of the first half, Dupixent^® was launched in 53 countries with greater than 300,000 patients on therapy.

Neurology and Immunology

In the second quarter, Neurology and Immunology sales were down 0.8% to €569 million, reflecting lower Kevzara^® and Aubagio^® sales. In the first half, Neurology and Immunology sales were down 2.2% primarily due to lower sales of Lemtrada^®.

Aubagio^® sales decreased slightly (down 0.4%) in the second quarter to €494 million, due to lower sales in the U.S. reflecting increased competition which was almost offset by increased demand in Europe (including clinical trial supply) and higher sales in Rest of the World. In June, the European Commission (EC) approved Aubagio^® for the treatment of pediatric patients 10 to 17 years of age with relapsing-remitting multiple sclerosis. This EC approval provides an additional year of marketing protection in the European Union.

Second-quarter Lemtrada^® sales increased 5.3% to €19 million resulting from higher sales outside the U.S. and reflecting a low base in second quarter 2020 due to COVID-19.

Second-quarter Kevzara^® (collaboration with Regeneron) sales were down 6.5% to €56 million due to lower sales in the U.S. and Rest of the World reflecting the recent strategic decision to reduce promotional efforts. 

Rare Disease

In the second quarter, Rare Disease sales increased 8.8% to €759 million, driven by higher demand in all three geographic regions and a low base for comparison in the second quarter of 2020 due to COVID-19. First-half sales of Rare Disease increased 6.5% reflecting growth across all three geographic regions.

Sales of the Gaucher franchise (Cerezyme^® + Cerdelga^®) increased 2.1% (to €226 million) in the second quarter. Second-quarter Cerezyme^® sales decreased 1.7% to €165 million, reflecting lower sales in Rest of the World (down 11.7%) due to shipment phasing in Latin America which more than offset growth in Europe and the U.S. Second-quarter Cerdelga^® sales increased 14.0% to €61 million driven by new patient accruals in the three geographic regions.

Second-quarter Myozyme^®/Lumizyme^® sales increased 14.6% to €248 million supported primarily by new patient accruals in the three geographic regions and improved treatment compliance in all three geographic regions.

Second-quarter Fabrazyme^® sales increased 9.0% to €204 million driven by higher sales in Europe (up 17.4%), in Rest of the World (up 9.8%) and in the U.S. (up 4.9%) reflecting new patient accruals and improved treatment compliance in all geographies. 

Oncology

Second-quarter and first-half sales of Oncology increased 25.4% (to €226 million) and 25.6%, respectively, driven by the Sarclisa^® and Libtayo^® launches which more than offset the impact of Jevtana^® generic competition in Europe.

Second-quarter Jevtana^® sales decreased 9.0% to €114 million following the entry of generic competition in certain European markets (down 26.8%) at the end of March. In the U.S., sales were up 6.3%, where the Jevtana^® composition of matter patent will expire in September 2021. Between May and July 2020, Sanofi filed patent infringement suits against all generic filers on Jevtana^® under Hatch-Waxman in the U.S. District Court for the District of Delaware asserting two method of use patents (US 10,583,110 and US 10, 716,777), both of which expire in October 2030. Sanofi has reached settlement agreements with some of the defendants and the suit against the remaining defendants is currently stayed.

Second-quarter Sarclisa^® sales were €40 million (versus €4 million in the second quarter of 2020) driven by additional country launches. Sarclisa^® is used together with two other combinations of medicines to treat adults with multiple myeloma who have at least received 1 prior therapy. Second-quarter sales in the U.S. and in Europe were €16 million and €14 million, respectively. Rest of the World sales (€10 million) were driven by strong performance in Japan.

Libtayo^® (collaboration with Regeneron) sales were €33 million (up 120.0%) in the second quarter driven by increased demand in metastatic cutaneous squamous cell carcinoma (CSCC) as well as additional country launches. Libtayo^® was also recently approved in the U.S. and Europe to treat patients with advanced basal cell carcinoma and as first-line treatment of patients with advanced non-small cell lung cancer with ≥50% PD-L1 expression. Libtayo^® sales in the U.S. are reported by Regeneron.

Rare Blood Disorder

In the second quarter, Rare Blood Disorder franchise sales increased 0.6% (€290 million). Excluding industrial sales to Sobi, second-quarter sales were up 17.1% reflecting growth of Alprolix^®, Eloctate^® and Cablivi^®. Alprolix^® and Eloctate^® industrial sales to Sobi are expected to be significantly lower in 2021 than in 2020 due to a change in the supply agreement. First-half sales of Rare Blood Disorder were stable and increased 11.1% when excluding industrial sales to Sobi.

Eloctate^® sales were €144 million in the second quarter, down 7.1%. Excluding industrial sales to Sobi, Eloctate sales were up 6.8% driven by higher U.S. sales (+7.0%) which benefited from one-time higher inventory level as a result of as a result of the move to an integrated distribution system. Sales in the Rest of the World were down 37.0% reflecting lower industrial sales to Sobi (which are recorded in this region).

Second-quarter Alprolix^® sales were down 6.0% to €100 million. Excluding industrial sales to Sobi, Alprolix^® sales were up 15.8%, mainly driven by patient switches from standard half-life factors and prophylaxis conversion and also benefited from a low base for comparison due to the impact of COVID-19 in the second quarter of 2020. Sales in the Rest of the World were down 51.3% reflecting lower industrial sales to Sobi (which are recorded in this region).

Cablivi^® generated sales of €46 million (up 75.0%) in the second quarter driven by increased disease and product awareness as well as adoption of new ISTH (International Society on Thrombosis and Haemostasis) TTP guidelines. In the U.S., sales of the product were €21 million (up 27.8%). In Europe, sales were €25 million (up 150.0%) primarily driven by additional country launches.

General Medicines

Second quarter General Medicines sales increased 4.2% to €3,546 million driven by the performance of the core assets² which were €1,428 million up 11.8% and up 14.9% excluding Praluent^® U.S. sales (in the comparable quarter last year). This performance also reflected a low base for comparison due to the impact of COVID-19 in the second quarter of the prior year which was compounded by the reversal of the stocking effect seen in the first quarter of 2020. Non-core assets sales were €1,926 million, down 0.5% reflecting portfolio streamlining (-1.6 ppt) and lower Aprovel^®/Avapro^® sales impacted by a short-term supply constraint. Second-quarter Industrial sales were €192 million up 1.6%. Excluding portfolio streamlining, second quarter General Medicines sales were up 5.2% (-1,0 ppt impact).

First-half General Medicines sales were down 0.1% to €7,218 million. First-half sales of the core assets were €2,902 million up 7.9%, driven by strong performance of Lovenox^®. Non-core assets sales were €3,936 million, down 5.6% reflecting portfolio streamlining (-2.4 ppt), as well as lower Lantus^® and Aprovel^®/Avapro^® sales. First-half Industrial sales were €380 million up 5.1%. Excluding portfolio streamlining, first-half General Medicines sales were up 1.2% (-1,2 ppt impact).

Diabetes

In the second quarter, global Diabetes sales performance (up 1.6% to €1,146 million) was due to growth in all three geographic regions and also reflected the low base in the second quarter of 2020. In the U.S., Diabetes sales increased 2.8% driven by Lantus^®. In Europe, sales increased 1.4% driven by Toujeo^®. In the Rest of the World, sales were up 0.8%. First-half Diabetes sales were down 0.1% mainly as a result of lower Lantus^® sales which more than offset the growth of Toujeo^® and Soliqua^®.

Second-quarter Toujeo^® sales increased 7.9% to €247 million reflecting growth in Rest of the World mainly due to Toujeo^® launch performance in China as well as the low base for comparison in Europe in the second quarter of 2020. In the U.S., Toujeo^® sales decreased 14.7% and mainly due to net price declines in spite of continued volume growth.

Lantus^® sales were €637 million, down 2.7% in the second quarter, mainly due to lower sales in Rest of the World and Europe as a result of more new patient starts onToujeo^® and biosimilar glargine competition. Sales of Lantus^® in the U.S increased 6.6% primarily due to higher volumes.

Second-quarter Soliqua^® sales increased 28.9% to €46 million driven by growth in all three geographic regions mainly due to launches in Rest of the World (up 50.0%) and performance in Europe (up 40.0%). The SoliMix study met both primary endpoints with Soliqua^® demonstrating non inferiority of blood sugar (HbA1c) reduction and superiority on body weight change from baseline compared to premixed insulin. The findings were presented at the American Diabetes Association (ADA) in June and simultaneously published in Diabetes Care.

Cardiovascular and Established Rx Products

*Excluding Auto generics

In the second quarter, Cardiovascular and Established Rx Products sales increased 5.9% to €2,208 million driven by strong growth of the core assets including Lovenox^®, Thymoglobulin^®, Mozobil^® and Multaq^® as well as reflecting the low base in the second quarter of 2020. This performance also reflected lower sales of Aprovel^®/Avapro^® and the impact of the divestments of non-core products. First-half Cardiovascular and Established Rx Products sales were down 0.4% mainly due to lower Aprovel^®/Avapro^® sales and the divestment which offset strong growth of several core assets.

Second-quarter Lovenox^® sales increased 24.6% to €367 million, were driven by strong sales in Europe (up 43.3%) and Rest of the World (up 13.8%) reflecting the recovery in hospital procedures and continued benefit from the WHO guidelines recommending the use of low molecular weight heparins in hospitalized COVID-19 patients, more than offsetting biosimilar competition in Europe.

Plavix^® sales were up 2.1% in the second quarter to €234 million mainly reflecting higher sales in Europe and in Rest of the World. In China, sales were €94 million, up 8.0% which offset lower sales in Japan.

Second-quarter Aprovel^®/Avapro^® sales were down 23.5% to €99 million reflecting a short-term supply constraint.

Second-quarter Praluent^® sales decreased 34.2% to €48 million, reflecting the restructuring of the collaboration with Regeneron effective April 1, 2020. Sanofi has sole responsibility for Praluent^® outside the U.S. while Regeneron has sole responsibility for Praluent^® in the U.S. Excluding U.S. sales in the comparable quarter last year, Praluent^® sales grew 29.7% driven by a strong performance in Europe (up 50.0%).

Multaq^® sales were €79 million, up 17.8% in the second quarter supported by increased HCP engagement as demand for antiarrhythmic drugs grew with the recovery from the pandemic in the U.S. market.

Pharmaceuticals business operating income

In the second quarter, business operating income (BOI) of Pharmaceuticals decreased 1.4% to €2,396 million mainly due to currency effects (up 4.6% at CER). The ratio of BOI to net sales decreased by 2.8 percentage points to 36.1%. At CER, the ratio decreased 2.6 percentage points reflecting higher SG&A spends, increased “Other operating expenses” mainly reflected Regeneron MAbs alliance and the reevaluation of retained Regeneron shares in 2020, despite an improvement of the gross margin ratio. First-half business operating income of Pharmaceuticals decreased 3.1% to €4,911 million (up 3.7% at CER). The ratio of BOI to net sales decreased by 1.7 percentage points to 37.2% (37.5% at CER). 

Vaccines

Second-quarter Vaccines sales grew 16.2% to €1,022 million reflecting increased booster and meningitis vaccinations in the U.S. driven by the low base for comparison due to COVID-19. First-half Vaccines sales grew 10.8% driven by the recovery of meningitis vaccines sales and pediatric combination sales in the U.S. as well as strong influenza southern hemisphere season more than offsetting the continued negative COVID-19 impact on the travel vaccines.

In the second quarter, Polio/Pertussis/Hib (PPH) vaccines sales decreased 5.6% to €520 million. Outside the U.S., PPH decreased -14.1% mainly due to lower birth rate. In Rest of the World, sales are also impacted by decline of Pentaxim^® sales in China as a result of the ongoing COVID vaccination campaign and negative phasing effect of Polio vaccines. In the U.S., PPH sales were up 48.1% primarily due to the low base for comparison in the second quarter of 2020. Vaxelis^TM, the first and only hexavalent combination vaccine approved in the U.S., was successfully launched in the U.S. in June 2021. Vaxelis^TM was developed as part of a joint-partnership between Sanofi and Merck. Vaxelis^TM in-market sales are not consolidated and the profits shared equally between the two parties. As Vaxelis™ is expected to replace partly current Pentacel^® sales in the U.S., PPH sales in this region are expected to decrease going forward.

Influenza vaccines sales increased by 8.6% in the second quarter to €119 million.

Second-quarter Meningitis sales were up 125.8% to €106 million mainly reflecting a recovery of meningitis vaccination in the U.S. combined with the launch of MenQuadfi^® in March 2021.

Adult Booster vaccines sales grew 42.3% in the second quarter to €186 million, due to a progressive recovery of Adacel^® vaccinations in the U.S.

Second-quarter Travel and other endemic vaccines sales increased 40.0% mainly driven by increased sales of yellow fever vaccines (endemic vaccine) in the Rest of the World, which largely offset low sales of travel-related vaccines due to the continued impact of travel restrictions globally.

On June 29, 2021 Sanofi launched a dedicated first-of-its kind vaccines mRNA Center of Excellence. Sanofi will bring together approximately 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, MA (US) and Marcy l’Etoile, Lyon (France), the Center will enable acceleration of the vaccines mRNA portfolio developed through the Translate Bio collaboration established in 2018 and expanded in 2020.

Vaccines business operating income

In the second quarter, business operating income (BOI) of Vaccines increased 18.8% to €227 million reflecting the strong sales growth. At CER, BOI increased 30.9%. The ratio of BOI to net sales was 22.2% (versus 20.6% in the second quarter of 2020). In the first half, BOI of Vaccines increased 32.9% (up 41.1% at CER) to €598 million reflecting strong sales as well as the payment from Daiichi Sankyo in the first quarter of 2021. The ratio of BOI to net sales increased 6.4 percentage points to 30.9% (31.2% at CER). 

Consumer Healthcare

In the second quarter, Consumer Healthcare (CHC) sales increased 11.9% to €1,089 million primarily reflecting a low base for comparison in the second quarter of 2020 as well as a strong performance of Digestive Wellness and Pain Care categories. This largely offset a weak cough and cold season due to social distancing measures. First-half CHC sales increased 1.2% mainly due to the growing sales in Digestive Wellness which more than offset a weak cough and cold season and the divestments of non-core products (-0.6 ppt impact).

In the U.S., second-quarter CHC sales increased 12.5% to €287 million driven by the sales in Digestive Wellness which benefited from Dulcolax^® performance.

In Europe, second-quarter CHC sales increased 7.7% to €319 million mainly reflecting strong growth of Pain Care driven by increased Doliprane^® sales as well as a solid performance of the Digestive and Mental Wellness categories which more than offset lower sales from the Cough, Cold and Flu category because of the impact of social distancing measures.

In the Rest of the World, second-quarter CHC sales increased 14.3% to €483 million, reflecting strong growth of Digestive Wellness mainly driven by Enterogermina^®, Buscopan^® and Essentiale^® as well as higher sales from the Pain Care, Mental Wellness and Allergy categories.

As part of Sanofi’s ongoing efforts to simplify its CHC portfolio and accelerate its growth trajectory, Sanofi signed in June an agreement with STADA for the divestiture of 16 CHC non-core brands commercialized in Europe.

CHC business operating income
In the second quarter, business operating income (BOI) of CHC increased 12.0% to €337 million. At CER, BOI increased 19.9% reflecting higher sales, a strict control of operational expenses. The ratio of BOI to net sales increased 1.5 percentage point to 30.9% versus the prior year. In the first half of 2021, BOI of CHC decreased 6.8% (up 2.2% at CER) to €731 million. The ratio of BOI to net sales decreased 0.5 percentage points to 33.2% (34.1% at CER).

Company sales by geographic region

Second-quarter and first-half sales in the U.S. increased 20.4% to €3,195 million and 13.3%, respectively, mainly driven by the strong sales performance of Dupixent^®, and Vaccines.
In Europe sales increased 14.4% in the second quarter to €2,244 million driven by double digit growth of the General Medicines and Specialty Care GBUs driven by Dupixent^® and reflecting the low base for comparison in the second quarter of 2020. First-half European sales increased 3.4% mainly due to the growth of Specialty Care products including Dupixent^®, Aubagio^® and Rare Disease products which more than offset lower Vaccines and CHC sales.

In the Rest of the World, sales increased 4.2% to €3,305 million in the second quarter driven mainly by the performance of Dupixent^®, Established Products, Oncology, Rare Disease and CHC which more than offset lower Vaccines and Rare Blood Disorders sales. Sales in China increased 4.0% to €654 million, driven by Dupixent^®, Toujeo^®, Established products and CHC performance which more than offset lower Vaccines sales. In Japan, second-quarter sales increased 4.8% to €396 million reflecting the strong performance of Dupixent^® and Sarclisa^® which more than offset lower sales of Established Products. In the Rest of the World, first-half sales increased 4.3% supported by growth of the Specialty Care products, including Dupixent^®.

R&D update at the end of the second quarter 2021

Regulatory update

• The European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion that long-term safety data from a study of adults with moderate-to-severe atopic dermatitis treated with Dupixent^® will be added to the Dupixent^® Summary of Product Characteristics (SmPC). Dupixent^® is the first and only available systemic treatment for atopic dermatitis that has been studied in adults for up to 3 years in a Phase 3 trial. Data from a single arm Phase 3 open label extension (OLE) trial showed the long-term safety profile in adults with moderate-to-severe atopic dermatitis treated with Dupixent^® and observed up to three years was generally consistent with what was observed in the controlled pivotal Phase 3 trials.
  
  
• The FDA approved a 200mg single-dose pre-filled pen for Dupixent^®. The pre-filled pen is approved for at-home administration for all Dupixent^® indications in patients aged 12 years and older, which include use in certain patients with atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP). The 200 mg pre-filled pen is anticipated to be available in the U.S. in August 2021 and provides an additional administration option for adults and adolescents who are prescribed Dupixent^®. The 300 mg dose of pre-filled pen was previously approved by the FDA and is currently available.
  
  
• The European Commission (EC) approved Libtayo^® as monotherapy in two advanced cancers. The EC approved 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. Approval is based on a Phase 3 trial demonstrating Libtayo^® significantly improved overall survival compared to chemotherapy in advanced NSCLC that included challenging-to-treat patient populations. Libtayo^® was also approved in adults with locally advanced or metastatic basal cell carcinoma (BCC) who have progressed on or are intolerant to hedgehog pathway inhibitor (HHI). Approval is based on data from the largest trial to date in patients with advanced basal cell carcinoma previously treated with hedgehog pathway inhibitors. Libtayo^® is now approved by the EC for three advanced cancers.
  
  
• The European Commission (EC) approved the second indication of Sarclisa^® for relapsed multiple myeloma. Approval is based on the Phase 3 IKEMA study demonstrating Sarclisa^® added to standard of care carfilzomib and dexamethasone reduced risk of disease progression or death by 47% in patients who had relapsed after one to three prior therapies. Sarclisa^® combination therapy was associated with undetectable levels of multiple myeloma in nearly 30% of patients with relapsed multiple myeloma. This marks the second EC approval of Sarclisa^® in combination with a standard of care regimen in less than 12 months. In addition, the IKEMA Primary Manuscript was published in The Lancet.
  
  
• The European Commission (EC) approved Aubagio^® for the treatment of pediatric patients 10-17 years of age with relapsing-remitting multiple sclerosis (RRMS). The EC approval is based on data from the Phase 3 TERIKIDS study. The approval confirms Aubagio^® as the first oral multiple sclerosis (MS) therapy for the first-line treatment of children and adolescents with MS in the European Union. Aubagio^® was initially approved in the EU in 2013 for the treatment of adult patients with RRMS and the EC approval for the pediatric indication provides an additional year of marketing protection in the European Union. The FDA issued a Complete Response Letter regarding the supplemental New Drug Application for Aubagio^® for children and adolescents 10-17 years of age with relapsing forms of multiple sclerosis. The FDA deemed the data submitted were not sufficient to obtain approval of an indication in the pediatric population at this time. The FDA updated the Aubagio^® label to include safety data from the pediatric clinical trial program. The indicated use of Aubagio^® in patients 18 years and older remains unchanged.
  
  
• The FDA granted fast track designation to rilzabrutinib for its development in pemphigus vulgaris. Rilzabrutinib is a Bruton’s tyrosine kinase inhibitor in Phase 3 development.
  
  
• Shan 6^®, a whole cell pertussis combined vaccine to prevent six diseases (Diphtheria, Tetanus, Pertussis, Polio, Hepatitis B and Haemophilus influenzae type b) for pediatric patients received market authorization from Indian authorities and is planned to be launched in 2022.
  
  

Portfolio update

Phase 3:

• Sanofi and GSK started a Phase 3 study to assess SP0253, an adjuvanted recombinant-protein COVID-19 vaccine candidate. The global, randomized, double-blind placebo-controlled Phase 3 study will include more than 35,000 volunteers aged 18 and older from several countries including sites in the U.S., Asia, Africa, and Latin America.
  
  
  • The primary endpoint of the study is the prevention of symptomatic COVID-19 in SARS-CoV-2 naïve adults. 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.
    
    
  • A Phase 2 in all adult age groups with 722 volunteers demonstrated strong rates of neutralizing antibody responses, in line with those measured in people who have recovered from COVID-19.
    
    
• A Phase 3 trial (MELODY) for nirsevimab, an extended half-life RSV antibody, demonstrated protection against respiratory syncytial virus (RSV) disease in healthy infants. Nirsevimab reached its primary endpoint, achieving a statistically significant absolute reduction of LRTI caused by RSV in healthy preterm and term infants compared to placebo through a typical RSV season. No clinically meaningful differences in safety results between the nirsevimab and placebo groups were seen. In addition, a Phase 2/3 trial (MEDLEY) evaluated the safety and tolerability of nirsevimab compared to palivizumab when given to infants at high risk of RSV entering their first RSV season. The trial assessed the safety of nirsevimab in infants with chronic lung disease (CLD), congenital heart disease (CHD), and/or prematurity. Occurrence of treatment emergent adverse events (TEAEs) or treatment emergent serious adverse events (TESAEs) were similar between groups. Full results from MELODY and MEDLEY are expected to be presented at a forthcoming medical meeting. MELODY, MEDLEY, and the Phase 2b trial will form the basis of regulatory submissions planned to begin in 2022.
  
  
• New pivotal data (CADENZA) for sutimlimab, a first-in-class C1s investigational inhibitor with the potential to be the first approved treatment for hemolysis in people with cold agglutinin disease, was presented in an oral session at the European Hematology Association (EHA) 2021 Congress. The results from CADENZA and data from the Phase 3 CARDINAL study, will be the basis of sutimlimab’s filing with the European Medicines Agency.
  
  
• A pivotal Phase 2/3 study of venglustat in autosomal dominant polycystic kidney disease (ADPKD) did not meet futility criteria and Sanofi has halted the clinical program in ADPKD. The STAGED-PKD study was stopped for futility following an independent analysis of the annualized rate of change in total kidney volume in patients receiving venglustat compared to placebo. The safety profile of venglustat remains consistent with previously reported results with more than 500 patients treated to date over a period of up to four years across all clinical programs. Clinical development continues in GM2 gangliosidosis, Fabry Disease, and Gaucher Disease type 3.

Phase 2

• Sarclisa^® started a Phase 1/2 trial in combination with novel agents in relapsed, refractory multiple myeloma. These combinations include SAR439459 (anti-TGFb antibody) and belantamab.
  
  
• Tusamitamab ravtansine, a first-in-class anti-CEACAM5 antibody drug conjugate started a Phase 2 trial (CARMEN-BT01) in patients with CEACAM5-positive advanced solid tumors.
  
  
• SAR445229, a potential first-in-class anti-OX40L, entered Sanofi’s pipeline following the closing of the acquisition of Kymab. A Phase 2b study is planned to start in atopic dermatitis in 2021.
  
  
• SAR441344, an anti-CD40L, started a Phase 2 trial in relapsing multiple sclerosis.
  
  
• SAR443122, a peripherally restricted small molecule inhibitor of RIPK1, started a Phase 2 study in patients with cutaneous lupus erythematosus (CLE).
  
  
• SAR445256, an anti-ICOS, entered the Sanofi Phase 2 pipeline following the closing of the acquisition of Kymab.
  
  
• SAR445088, a complement C1’s inhibitor, started a study in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
  
  
• SP0218, a vero cell vaccine for yellow fever, started a study in adults in the U.S.

Phase 1

• SP0273, an mRNA monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus, started a trial to evaluate safety and immunogenicity.
  
  
• SAR444881, a potential first-in-class anti-ILT2, in collaboration with Biond is being tested in solid tumors.
  
  
• Sutimlimab, a complement C1s inhibitor, was discontinued in Immune Thrombocytopenic Purpura.
  
  
• SAR441236, a trispecific in development for HIV, was licensed to ModeX Therapeutics under which ModeX will assume development except for some retained obligations related to the ongoing clinical trial (A5377) sponsored by DAIDS/NIH.

Collaborations

• On June 17, 2021 Sanofi entered a collaboration with CytoReason to utilize CytoReason’s artifical intelligence cell-centered models and deconvolution techniques to suggest mechanistic insights for each asthma endotype. The focus of this project is to gain clarity on the heterogeneity of asthma patients, with the goal of identifying stable and reproducible asthma endotypes, as well as associated diagnostic features, using minimal invasive procedures.
  
  
• On June 17, 2021 Sanofi entered into a worldwide exclusive license agreement with Racho Santa Fe Bio, Inc (RSF Bio) to provide RSF Bio with Sanofi’s rights to Ataciguat, a novel anthranilic acid derivative in development for calcific aortic valve stenosis (CAVS).
  
  
• On May 13, 2021 Sanofi and Genomic Vision announced successful completion of work package one of a three-part research agreement for the genetic characterization of Sanofi cell banks. These results paved the way to a better understanding of the generic characterization of transferred cell lines.
  
  
• On May 6, 2021 Sanofi established a three-year collaboration with Stanford Medicine to accelerate immunology research. Projects will led by collaborating researchers from the two organizations and will focus on automimmune diseases and inflammatory conditions.
  
  
• On April 12, 2021 Sanofi entered a licensing agreement with C4X Discovery for its oral pre-clinical IL-17A inhibitor program.
  
  

Acquisitions

• On April 16, 2021 Sanofi completed its acquisition of Kiadis, 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. 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.
  
  
• On April 9, 2021 Sanofi acquired Tidal Therapeutics, a privately owned, pre-clinical stage biotech company with a novel mRNA-based approach for in vivo reprogramming of immune cells. The new technology platform will expand Sanofi’s research capabilities in both immuno-oncology and inflammatory diseases, and may have applicability to other disease areas as well.
  
  
• On April 9, 2021 Sanofi completed the acquisition of Kymab Group Ltd., adding KY1005 to its pipeline, a fully human monoclonal antibody targeting key immune system regulatory of OX40L. This acquisition continues to build on Sanofi’s leading presence in immunology aligned with the company’s strategy to pursue best-in-class treatments in defined areas. Kymab’s pipeline also added the oncology asset KY1044, an ICOS agonist monoclonal antibody, currently in early Phase1/2 development as monotherapy and in combination with an anti-PD-L1.
  
  

Agreements related to COVID-19 vaccines

• On April 26, 2021 Sanofi announced it will help manufacture Moderna COVID-19 vaccine supporting global supply demand. Sanofi plans to manufacture up to 200 million doses of Moderna’s vaccine in the U.S. starting in September 2021.
  

An update of the R&D pipeline at as of June 30, 2021, is available on our website: 
https://www.sanofi.com/en/science-and-innovation/research-and-development

Progress on implementation of the Corporate Social Responsibility strategy

Environment

As part of a long-standing commitment to reduce the environmental footprint of the company’s products and activities, Sanofi launched a €3 million Planet Mobilization fund to support employee ideas and projects that will further contribute to a healthier environment. More than 500 employees from 63 sites in 29 countries participated in the company’s environmental sustainability ideation program and three winning projects were selected this inaugural year. “Rice is the New Green” is a project from Sanofi Vietnam to implement the first green and circular large-scale rice husk biomass energy project. IDRA” is a project from three country sites in Europe, aiming at recycling treated wastewater from the sites to be directly reused on site. Finally “Waterford Loves Planet Not Plastic” is an education project to help reduce plastic waste around Waterford site in Ireland.

Social Responsibility

In May 2021, Sanofi released its new Diversity and Inclusion Strategy with a renewed commitment to reflect the diversity of its communities, unleashing everyone’s best self every day to transform the practice of medicine. Combining global ambition with local challenges, this strategy builds upon strong foundations. On gender parity, the percentage of women in senior leadership positions globally has increased by 4 points over the past two years to 40%. In the US, people of color now represent 31% of employees, up 2 points from Q2 2019.

Many best practice initiatives of how Sanofi includes diverse communities in its workforce are taking place across Sanofi’s organization: Pride Month in June was the opportunity for teams in many countries to drive local campaigns providing LGBTQIA+ communities with forums to create a culture of inclusion and equality at work and beyond.

2021 second-quarter and first-half financial results

Business Net Income³

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