SANOFI - AVENTIS GROUPE


Associated tags: Medicine, Science, Social responsibility, Pharmaceutical industry, Patient, Sanofi

Locations: AD, DC, WASHINGTON, HAIR, PARIS, FR, FRANCE

Press Release: Availability of the Q1 2024 Memorandum for modelling purposes

Retrieved on: 
Friday, March 22, 2024

Paris, France – March 22, 2024.

Key Points: 
  • Paris, France – March 22, 2024.
  • Sanofi announced today that its Q1 2024 Memorandum for modelling purposes is available on the "Investors" page of the company's website:
    As for each quarter, Sanofi prepared this document to assist in the financial modelling of the Group's quarterly results.
  • This document includes a reminder on various non-comparable items and exclusivity losses as well as the foreign currency impact and share count.
  • Sanofi's first-quarter 2024 results will be published on April 25, 2024.

Press Release: New Phase 2b results for amlitelimab support potential for best-in-class maintenance of response in atopic dermatitis

Retrieved on: 
Monday, March 11, 2024

The safety profile was consistent with Part 1 of the study with amlitelimab being well-tolerated and no new safety concerns identified.

Key Points: 
  • The safety profile was consistent with Part 1 of the study with amlitelimab being well-tolerated and no new safety concerns identified.
  • Overall rates of treatment-emergent adverse events (TEAEs) were 69.8% for continued amlitelimab treatment, 71.9% for the amlitelimab withdrawal-arm and 66.7% for placebo.
  • TEAEs more commonly observed included headache (11.6% amlitelimab continuation, 3.9% amlitelimab withdrawal, 6.7% placebo), upper respiratory tract infection (9.3% amlitelimab continuation, 5.5% amlitelimab withdrawal, 20% placebo).
  • Amlitelimab is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.

Press Release: Phase 2 results demonstrate rilzabrutinib rapidly reduced itch severity and significantly improved disease activity in adults with chronic spontaneous urticaria

Retrieved on: 
Saturday, February 24, 2024

Positive results from the Phase 2 study RILECSU showed that rilzabrutinib significantly improved itch, hives and urticaria in adults with moderate-to-severe chronic spontaneous urticaria (CSU), whose symptoms are not adequately controlled by H1 antihistamines.

Key Points: 
  • Positive results from the Phase 2 study RILECSU showed that rilzabrutinib significantly improved itch, hives and urticaria in adults with moderate-to-severe chronic spontaneous urticaria (CSU), whose symptoms are not adequately controlled by H1 antihistamines.
  • Significant reduction from baseline to week 12 in weekly urticaria activity score (UAS7) [LSM -17.95 vs -11.20, respectively; p=0.0116].
  • Significant reduction from baseline to week 12 in weekly hives severity score (HSS7) [LSM -8.31 vs -4.89; p
  • Rilzabrutinib is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.

Press Release: Filing of the 2023 U.S. Form 20-F and French “Document d’Enregistrement Universel” containing the Annual Financial Report

Retrieved on: 
Friday, February 23, 2024

Filing of the 2023 U.S. Form 20-F and French “Document d’Enregistrement Universel” containing the Annual Financial Report

Key Points: 
  • Filing of the 2023 U.S. Form 20-F and French “Document d’Enregistrement Universel” containing the Annual Financial Report
    Paris, February 23, 2024.
  • Sanofi announces today the filing of its Form 20-F with the U.S. Securities and Exchange Commission (SEC) and its “Document d’Enregistrement Universel” containing its Annual Financial Report with the French market regulator Autorité des marchés financiers (AMF).
  • These documents are available on the company’s website: https://www.sanofi.com/en/investors/reports-and-publications/financial-r...
    In addition, the Form 20-F is available on the website of the SEC ( www.sec.gov ) and the “Document d’Enregistrement Universel” is available on the website of the AMF ( www.amf-france.org ).
  • A hard copy of these documents, each of which contains our complete audited financial statements, may be received free of charge, upon request.

Press Release: Dupixent® sBLA accepted for FDA Priority Review for treatment of COPD with type 2 inflammation

Retrieved on: 
Friday, February 23, 2024

The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) in a sixth potential indication as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD).

Key Points: 
  • The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) in a sixth potential indication as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD).
  • The target action date for the FDA decision is June 27, 2024.
  • In both trials, Dupixent also rapidly and significantly improved lung function compared to placebo, with improvements sustained at 52 weeks.
  • Priority Review is granted to regulatory applications seeking approval for therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions.

Press Release: Sanofi’s Board of Directors proposes the appointment of Clotilde Delbos, Anne-Françoise Nesmes and John Sundy as independent Directors

Retrieved on: 
Thursday, February 22, 2024

Sanofi’s Board of Directors proposes the appointment of Clotilde Delbos, Anne-Françoise Nesmes and John Sundy as independent Directors

Key Points: 
  • Sanofi’s Board of Directors proposes the appointment of Clotilde Delbos, Anne-Françoise Nesmes and John Sundy as independent Directors
    Paris, February 22, 2024.
  • The Chairman warmly thanked them for their valued contribution to the Board of Directors and the specialized committees to which they belonged during their terms in office.
  • In 2016, Clotilde Delbos was appointed Group Chief Financial Officer and Chairman of Board of Directors of RCI Banque.
  • “The arrivals of Clotilde Delbos, Anne-Françoise Nesmes and John Sundy will strengthen the Board of Directors’ expertise in finance and science, notably in the field of immunology.

Press Release: Japan first in the world to approve Dupixent® for chronic spontaneous urticaria (CSU)

Retrieved on: 
Friday, February 16, 2024

Japan is the first country to approve Dupixent for CSU, emphasizing the value of Dupixent as a novel treatment option to manage this disease in patients with unmet needs.

Key Points: 
  • Japan is the first country to approve Dupixent for CSU, emphasizing the value of Dupixent as a novel treatment option to manage this disease in patients with unmet needs.
  • CSU is a chronic inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and persistent itch.
  • CSU is typically treated with histamine (H1) antihistamines, medicines that target H1 receptors on cells to control symptoms of urticaria.
  • In addition to CSU, Dupixent is approved in Japan in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), and prurigo nodularis.

Press Release: Phase 2 data published in NEJM show potential of frexalimab as high-efficacy therapy in relapsing MS

Retrieved on: 
Thursday, February 15, 2024

Findings also showed both doses of frexalimab provided significant reduction in new or enlarging T2 lesions, a secondary endpoint of the study.

Key Points: 
  • Findings also showed both doses of frexalimab provided significant reduction in new or enlarging T2 lesions, a secondary endpoint of the study.
  • Frexalimab is Sanofi’s novel second-generation investigational anti-CD40L antibody that has a unique method of action with the potential to address both acute and chronic neuroinflammation in MS without causing lymphocyte depletion.
  • “These published Phase 2 results for frexalimab represent important data in not only the potential treatment of MS but to the broader MS community.
  • Sanofi has initiated Phase 3 clinical trials of frexalimab in relapsing MS and non-relapsing secondary progressive MS.

Press Release: Peer support, flexible work arrangements, salary for a year: Sanofi launches global program for employees affected by cancer and critical illnesses

Retrieved on: 
Monday, February 5, 2024

Sanofi today launches ‘Cancer & Work: Acting Together’, a global program to support Sanofi employees whose lives are impacted by cancer and other critical illnesses.

Key Points: 
  • Sanofi today launches ‘Cancer & Work: Acting Together’, a global program to support Sanofi employees whose lives are impacted by cancer and other critical illnesses.
  • This program covers all Sanofi employees in the world if they are diagnosed with cancer or critical illnesses*.
  • The last thing you want to be thinking about when you are diagnosed with cancer, or going through treatment, is work.
  • The program also addresses the emotional wellbeing of Sanofi employees impacted by cancer and other critical illnesses.

Press Release: François-Xavier Roger appointed Chief Financial Officer, member of Sanofi Executive Committee

Retrieved on: 
Thursday, February 1, 2024

François-Xavier Roger appointed Chief Financial Officer, member of Sanofi Executive Committee

Key Points: 
  • François-Xavier Roger appointed Chief Financial Officer, member of Sanofi Executive Committee
    Paris, February 1, 2024.
  • François-Xavier Roger will be appointed Chief Financial Officer and a member of Sanofi’s Executive Committee effective April 1, 2024.
  • He is a seasoned executive who has lived and worked in Europe, the U.S, Asia, Africa and Latin America.
  • My decision to head Apprentis d’Auteuil was also fuelled by my growing passion for the impact Sanofi has around the world.