Sanofi: Press Releases, Monday, December 9, 2019
- Organic investment
- Business Development and M&A activities, focusing on bolt-on, value-enhancing opportunities to drive scientific and commercial leadership in core therapeutic areas
- Growing the annual dividend
- Anti-dilutive share buybacks
Additionally, Sanofi has the potential to raise capital through asset disposals, including streamlining “tail” brands in its Established Products business, and by monetizing its stake after the expiry of the lock-up under the amended and restated investor agreement with Regeneron.
R&D update
| Consult Appendix 1 for full overview of Sanofi’s R&D pipeline |
Regulatory update
Regulatory updates since October 31, 2019 include the following:
- In November, the FDA approved a supplemental Biologics License Application for Fluzone® High-Dose Quadrivalent (Influenza Vaccine) for use in adults 65 years of age and older.
As of November 2019, the R&D pipeline contained 84 projects, including 37 new molecular entities in clinical development (or that have been submitted to the regulatory authorities). 35 projects are in phase 3 or have been submitted to the regulatory authorities for approval.
Portfolio update
Phase 3:
- In December, positive results from the pivotal Phase 3 trial in patients with cold agglutinin disease (a type of anemia) for sutimlimab, a humanized, monoclonal antibody designed to directly target the classical complement pathway (C1s), will be presented at the Late-Breaking Abstracts Session of the 61st Annual Meeting of the American Society of Hematology in Orlando, Florida. Results from this trial will be submitted to regulatory authorities, starting with the U.S. Food and Drug Administration (FDA) in the near future
- In December, a Phase 3 study evaluating the extended pharmacology, once-weekly, Factor VIII replacement BIVV001 in patients with hemophilia A was initiated.
- In November, positive results from the Phase 3 trial for Toujeo® in children and adolescents with type 1 diabetes were presented at the International Society of Pediatrics and Adolescent Diabetes 45th Annual Conference in Boston.
- In November, plans to initiate Phase 3 studies in dupilumab in additional Type 2 inflammatory diseases were announced, including studies in prurigo nodularis, bullous pemphigoid, chronic spontaneous urticaria and allergic bronchopulmonary aspergillosis.
Phase 2:
