Sanofi to develop dupilumab in type 2 inflammatory diseases

Sanofi executives will provide an overview of the growth and development strategy for Dupixent (dupilumab) in the third of its five-part series to highlight Sanofi’s progress. Sanofi co-develops and co-commercializes Dupixent with Regeneron ().

The company is targeting the below additional indications. 

  • Eosinophilic Esophagitis (EoE)
  • Chronic Obstructive Pulmonary Disease (COPD) with Evidence of Type 2 Inflammation
  • Prurigo Nodularis (PN)
  • Chronic Spontaneous Urticaria (CSU)
  • Bullous Pemphigoid (BP)

All of these potential uses are investigational, and the safety and efficacy of Dupixent in any of these indications has not been evaluated yet.

While additional data contribute to the growing body of evidence demonstrating Dupixent’s best in class safety profile combined with strong efficacy benefit for atopic dermatitis and further validate it as a standard of care treatment for asthma; Dupixent’s unique mechanism of action simultaneously inhibits IL-4 and IL-13, which play a key role in type 2 inflammation in multiple diseases. 

Regeneron reports 1Q 2020 financial and operating results

Regeneron Pharmaceuticals, Inc. () today announced financial results for Q1 2020 and provided a business update. […]
The company has revised the accounting presentation to better reflect the nature of revenues earned and costs incurred, and simplify the financial reporting. The company has also closed the Praluent restructuring transaction with Sanofi, which is expected to be accretive beginning in Q2 2020.
  • Q1 2020 revenues increased 33% to $1.83 billion versus Q1 2019
  • Q1 2020 EYLEA U.S. net sales increased 9% to $1.17 billion versus Q1 2019
  • Q1 2020 Dupixent global net sales, which are recorded by Sanofi, increased 129% to $855 million versus Q1 2019
  • Q1 2020 GAAP diluted EPS was $5.43 and non-GAAP diluted EPS was $6.60
  • The Company generated $528 million in free cash flow for Q1 2020, compared to $823 million for Q1 2019.
  • Effective January 1, 2020, Regeneron has implemented changes in the presentation of its financial statements related to certain reimbursements and other payments for products developed and commercialized with collaborators.
  • Regeneron has more than 20 product candidates in clinical development, including five marketed products for which it is investigating additional indications.
  • In February 2020, the Company announced positive two-year results from the Phase 3 PANORAMA trial evaluating EYLEA in patients with moderately severe to severe non-proliferative diabetic retinopathy (NPDR). The two-year data demonstrated that EYLEA reduced the likelihood of developing vision-threatening events by at least 75% in patients with NPDR.
  • The U.S. Food and Drug Administration (FDA) accepted for priority review the supplemental Biologics License Application (sBLA) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis, with a target action date of May 26, 2020. In addition, a Marketing Authorization Application (MAA) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis has also been submitted in the European Union (EU). The sBLA for the 300 mg auto-injector is under review by the FDA, with a target action date of June 20, 2020.
  • In April 2020, the Company and Sanofi announced that the primary endpoint was met in the Phase 3 trial of Libtayo® (cemiplimab) as monotherapy in first-line non-small cell lung cancer (NSCLC). The Independent Data Monitoring Committee recommended that the trial be stopped early due to highly significant improvement in overall survival. The data from the trial will form the basis of regulatory submissions in the U.S. and EU in the second half of 2020.
  • In March 2020, the Company announced that the Phase 3 trial in adult patients with homozygous familial hypercholesterolemia (HoFH) met its primary endpoint and plans to submit an sBLA in mid-2020.
  • In March 2020, the Company presented positive, detailed results from the Phase 3 trial in patients with HoFH. The Company has also initiated a rolling BLA submission for HoFH and plans to submit an MAA in the EU in the second half of 2020.
  • The FDA accepted for priority review the BLA submission for -EB3, a multi-antibody therapy to Ebola virus infection, with a target action date of October 25, 2020.