Under CEO Paul Hudson, Sanofi has moved aggressively to bolster its presence in cancer and immunology, two areas of rapid drug development progress.
A $2.5 billion buyout for Synthorx last fall checked the first box, while the acquisition of Principia strengthens Sanofi’s control of a drug pipeline for the second.
Deals are needed because Sanofi, long a leader in diabetes and cardiovascular drugs, has a thinner pipeline in both areas than some of its pharmaceutical peers.
Unlike the assets brought under Sanofi’s banner from Synthorx, Principia’s are more advanced. The company’s two lead candidates belong to a class of drugs that block an enzyme known as Bruton’s tyrosine kinase. The enzyme is the target of approved therapies for several blood cancers, but Sanofi and Principia believe blocking it could play an important role in treating multiple sclerosis and other immune disorders.
Sanofi bought into Principia’s research in 2017, paying $40 million upfront to license a drug called SAR442168 and promising some $765 million more. The collaboration gave Sanofi global rights to the treatment, but granted Principia royalties on any future sales.
Per the terms of that earlier deal, Principia also secured an option to either share in the drug’s U.S. profits or earn a higher royalty rate, in exchange for helping to fund Phase 3 development. The biotech was expected to make a decision on whether to exercise that option by the end of this year.
Sanofi has highlighted Principia’s drug as one of several major therapies in its pipeline, putting on several presentations to lay out its potential to investors. That potential appears to have made the royalties it would owe to Principia too expensive. By acquiring the company, Sanofi gains full ownership of any future profits, and wipes some $660 million in conditional payments from the pharma’s future obligations to Principia.
Proving ‘168 in multiple sclerosis will still take some time, however. After announcing positive Phase 2 results in April, Sanofi has revealed plans for a Phase 3 clinical program involving three large trials. The first is expected to complete in the first half of 2024.
If successful, ‘168 would join a crowded field of multiple sclerosis therapies. But Sanofi sees the drug’s oral dosing, combined with its ability to get into and work in the brain, could make the drug a competitive treatment option. Phase 2 data showed the drug reduced the number of new brain lesions by 85% versus placebo after three months.
Merck KGaA is also developing an oral BTK inhibitor for multiple sclerosis, which it advanced into late-stage testing last year.
Sanofi will also get access to Principia’s other BTK inhibitor, a drug called rilzabrutinib that’s in development for a rare autoimmune disease called pemphigus and the blood disorder immune thrombocytopenia.
The deals for Synthorx and Principia are unlikely to be Sanofi’s last under Hudson. In late May, the drugmaker sold more than $11 billion worth of shares it held in longtime biotech collaborator Regeneron, a sum that could help fund future acquisitions or drug licensing agreements.