Sanofi Highlights Late-Stage Pipeline, R&D PrioritiesBy
Sanofi has outlined its progress in implementing its research and development strategy, development pipeline, and milestones for 2018, as part of the company’s 2020 strategic roadmap, which includes a shift from small molecules to biologics.
As a pillar of Sanofi’s “2020 Roadmap”, Sanofi says its new R&D model is based on three key strategic shifts: from small molecules to biologics; from mono-targeting to multi-targeting compounds; and from licensing to proprietary assets.
The company’s pipeline includes 71 R&D projects, which includes 37 new molecular entities and vaccines. Sanofi expects at least 10 Phase III studies to start over the next 12 months and plans to evaluate new treatments for the following: chronic obstructive pulmonary disease and eosinophilic esophagitis (dupilumab); autosomal dominant polycystic kidney disease, a rare kidney disease (venglustat); Type II diabetes (efpeglenatide, a once-weekly GLP-1 agonist); obesity (a GLP-1/GCG dual agonist); primary progressive multiple sclerosis (alemtuzumab), and; first line non-small cell lung cancer (cemiplimab).
Sanofi says its regulatory filings expected in the next 12 months include two investigational cancer drugs (cemiplimab and isatuximab), a therapy for Type I diabetes (sotagliflozin) and a potential treatment for uncontrolled, persistent asthma (dupilumab).
For its immunology portfolio, the company says dupilumab, which it is developing in collaboration with Regeneron, has potential across multiple indications. Submission in the indication for uncontrolled, persistent asthma is expected before the end of 2017. Sanofi says clinical development is underway in nasal polyposis, eosinophilic esophagitis, food allergies, and in pediatric populations in most of these indications. Additionally, Phase III development for dupilumab is now planned in COPD. Sanofi, in collaboration with Regeneron, also expects to bring SAR440340, an anti-IL-33 antibody, which the companies say has potential for a broader spectrum of immune modulation, into Phase II in atopic dermatitis, asthma, and COPD in 2018, alone or in combination with dupilumab.