Sanofi, facing skeptical investors, predicts $5B sales for 3 drugs, names 9 more blockbusters
07 Dec 2023
Phase 2AcquisitionPhase 3Clinical Trial FailurePhase 1
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Source: FierceBiotech
Sanofi expects to increase its number of phase 3 trials by 50% between 2023 and 2025.
Sanofi has tipped three “pipeline-in-a-product” assets to generate 5 billion euros ($5.4 billion) a year or more. The forecasts are part of a set of predictions intended to justify the drugmaker’s decision to funnel cash into key programs rather than increase its operating profit margin.
In October, Sanofi’s decision to ditch its margin target and instead reinvest cash in the development and growth of key products shocked investors, who responded by sending the company’s stock down almost 20%. Thursday, Sanofi will use its R&D day to make the case for diverting money into a set of candidates that could define the mid-term future of the company.
Sanofi shared high-level details of its plan in a press release published ahead of the event. The statement identifies three drugs—amlitelimab, frexalimab and SAR441566—with peak sales potential of more than 5 billion euros.
Amlitelimab is the anti-OX40-ligand monoclonal antibody that Sanofi acquired in its $1.1 billion takeover of Kymab. The molecule hit the mark in a phase 2b atopic dermatitis trial earlier this year, encouraging the company to commit to a phase 3 program, expand into other indications and start envisioning big blockbuster sales.
Frexalimab, a CD40L monoclonal antibody, also cleared a midphase test earlier this year. The multiple sclerosis (MS) readout suggested Sanofi may have overcome the blood clot risks that sank earlier CD40 drug candidates. Sanofi sees opportunities for the asset beyond MS and, with the Inflation Reduction Act shaping its thinking, wants to pursue multiple indications in parallel.
The third 5 billion euro drug candidate is SAR441566, a small molecule TNF inhibitor that Sanofi views as a way to provide biologic-like efficacy in an oral dosage form. Sanofi recently began phase 2 trials of the molecule in rheumatoid arthritis and plaque psoriasis.
Beyond its three biggest prospects, Sanofi identified nine other medicines and vaccines that could rack up peak sales of more than 2 billion euros. The list includes tolebrutinib, the MS prospect that Sanofi picked up in its $3.7 billion Principia Biopharma buyout, and the IRAK4 degrader covered by its deal with Kymera Therapeutics.
As Sanofi advances the candidates, it expects to increase its number of phase 3 trials by 50% between 2023 and 2025. Readouts from those clinical trials and other ongoing studies will shape whether Sanofi’s decision to reinvest money in programs pays off, and go some way to determining how history views Paul Hudson’s time as CEO and the bets he made while in the post.
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