Sanofi CEO Paul Hudson bet big on immunology. When Belén Garijo takes over as CEO next week, she will have to decide whether to continue that wager.
The direction Garijo elects to pursue will likely have ramifications not just for Sanofi’s R&D future, but for the company’s identity. Under Hudson, Sanofi went all-in on immunology, trying to tackle a wide range of diseases, from eczema and asthma to multiple sclerosis and rare neuroinflammatory conditions.
But Hudson’s efforts left a mixed track record in the clinic, and it probably doesn’t make sense for Garijo to continue down the same path, Jefferies managing director Michael Leuchten said in an interview.
“All-in on immunology, I think that’s off the table,” Leuchten said. “They haven’t been able to deliver on the strategy, and frankly, the strategy has failed because they cannot be the power in immunology, for whatever reason.”
An R&D “reset” is probably where Sanofi is headed under Garijo, Leuchten said, but the timing may be tricky. The megablockbuster anti-inflammatory drug Dupixent is expected to lose its market exclusivity in the early 2030s, bringing a sense of urgency. (Sanofi co-develops Dupixent with Regeneron.)
But reinvigorating a big pharma pipeline is a massive undertaking, Leuchten said, noting AstraZeneca’s relatively quick turnaround took seven years.
It’s not yet clear how Garijo plans to steer Sanofi’s R&D as her tenure begins April 29. When Hudson’s departure was announced in February, a Sanofi spokesperson told
Endpoints News
that its strategic priorities will remain unchanged under Garijo. But whether that applies to R&D is up in the air.
A Sanofi spokesperson told Endpoints on Wednesday that the company’s “deep understanding of immunoscience continues to underpin our approach to R&D,” particularly in immunology, vaccines and rare disease.
“We remain confident in our R&D strategy and the potential of our pipeline to drive the future growth of Sanofi,” the spokesperson said. “There is risk inherent in all portfolios, and our pipeline is regularly and rigorously assessed so we may quickly redeploy capital to areas we believe will deliver the greatest value to Sanofi and to patients.”
Sanofi’s R&D
presentation
from December 2023 highlights the gap between potential and reality. The company
claimed
it could develop a dozen blockbuster drugs, including three that could reach $5 billion in annual peak sales: amlitelimab, in eczema and asthma; frexalimab, in type 1 diabetes and multiple sclerosis; and balinatunfib, in rheumatoid arthritis, psoriasis and inflammatory bowel disease.
Two of those three programs are now unlikely to reach those heights after underwhelming in the clinic.
Amlitelimab, an anti-OX40 drug, succeeded in its Phase 3 study but appeared to underperform market leader Dupixent.
An unexpected safety concern also arose that now threatens to kneecap the entire anti-OX40 drug class, as Amgen and Kyowa Kirin
halted development
of a similar program.
Balinatunfib, an oral TNF inhibitor, failed two mid-stage studies in rheumatoid arthritis and psoriasis last year. Sanofi blamed a high placebo response rate in the former trial — an issue that’s growing more prominent in immunologic disease studies, Leuchten noted.
The reasons aren’t always clear, but
Roche
and
MoonLake Immunotherapeutics
also pinned recent setbacks on similar issues. In rheumatoid arthritis, in particular, researchers have found that the placebo effect is “not limited to subjective outcomes,” according to a
2020 paper published in
JAMA
.
The third drug, frexalimab,
succeeded
in a Phase 2 multiple sclerosis trial, with pivotal trials underway.
Sanofi has a few ways it can try to mitigate the Dupixent patent cliff, Leuchten said. It can continue to invest in internal R&D, swing a couple of bolt-on acquisitions, or a combination of the two.
Hudson pursued such a strategy in immunology, but the likelihood of Garijo focusing primarily on this area is low. “I wouldn’t expect them to sort of keep hammering down that same strategy, because it’s not really a strategy that makes a lot of sense,” Leuchten said.
Sanofi’s board may be hoping to buy some time for the Dupixent cliff, Leuchten added. At the outset of Garijo’s tenure, deals will probably be part of the picture as a shorter-term bridge. After that, the focus could turn to more significantly overhauling the internal R&D engine.
Sanofi could also combine those efforts with other “intellectual property protection” measures to extend the Dupixent exclusivity period, Leuchten said. Pushing the timeline from the early 2030s to mid-2030s would give the company much-needed breathing room.
“Once that is sorted, you then go back and try to figure out how to do an R&D reset,” Leuchten said.
Sanofi’s first-quarter earnings report is scheduled for Thursday.