R&D

Sanofi faces a make-or-break year, saying it’s ready to put a 3-prong R&D strategy to a pivotal test

With the help of some key development partners, Sanofi set out today to try and prove to an increasingly skeptical group of investors that it can control its own destiny with a late-stage pipeline bristling with blockbuster contenders.

Oliver Brandicourt, Sanofi CEO

But with a decade-long track record largely absent of big, in-house success stories and its “blockbuster” Dengvaxia in a shambles, caught up in a global safety crisis that has crushed its potential, that’s no easy task.

Under CEO Olivier Brandicourt and chief scientist Elias Zerhouni, the pharma giant has pursued a three-prong R&D strategy for two years: Shift from small molecules to biologics; advance from a monotherapy approach to combos; and drop the reliance on licensing with a new emphasis on developing their own, wholly-owned assets.

That’s a work in progress, though, even as Sanofi touts a shot at 9 regulatory submissions in 18 months with the launch of 10 pivotal trials by the end of 2018. The outline also includes one shelved program and key partnerships with Regeneron, Alnylam, Myokardia and Principia.

The key question here is whether a big operation like Sanofi, which has relied on alliances to produce innovation, can actually do something important on its own. And this after former CEO Chris Viehbacher concluded that it was too big and too slow to accomplish anything significant without lots of help. Investors, meanwhile, have been grumbling throughout CEO Olivier Brandicourt’s rein that the company’s best hope for fast progress lies in M&A, which has yet to materialize.

Elias Zerhouni

Sanofi’s R&D presentation starts with a boast about the Phase III potential of Dupixent — partnered with Regeneron — for COPD. Sanofi also has high hopes for another anti-inflammatory, the anti-IL-33 drug SAR440340, partnered with Regeneron. And they separately heralded the positive pivotal data for their PD-1 cancer checkpoint drug cemiplimab, also partnered with Regeneron.

The pipeline review notes that Sanofi is taking this treatment into a pivotal program for frontline lung cancer — a field that has attracted the intense interest of every major checkpoint player.

Here’s the rest of the lineup now in the spotlight, with a breakdown by disease focus:

Oncology

  • Isatuximab, a home grown anti-CD38 antibody, is in the clinic for multiple myeloma and will be studied as a combination therapy with their checkpoint cemiplimab, with investigators pursuing signs that the add-on could have an effect on PD-1 resistance. This drug represents some renewed expectations in oncology, close to three years after a reorganization on the cancer front following some significant failures and the departure of Tal Zaks.

Multiple sclerosis

  • Lemtrada — acquired in the Genzyme buyout — is being studied for the primary, progressive form of multiple sclerosis. Another drug, GLD-52, is being “deprioritized” to keep the spotlight on Lemtrada. And there’s a BTK drug for MS partnered with Principia.

Rare diseases

  • There’s a drug called venglustat for rare cases of autosomal dominant polycystic kidney disease. And the pharma giant sees potential here for Fabry Disease, Gaucher Disease Type 3 and GBA Parkinson’s Disease.
  • Two other rare disease drugs — olipudase and avalglucosidase alfa — are getting the spotlight treatment today.
  • And the focus on rare diseases finishes with the alliance with Alnylam, which is doing the development work for patisiran and fitusiran.

Diabetes and cardio

  • There’s a once-weekly GLP-1 drug looking to join the field. It’s called efpeglenatide.
  • An oral dual agonist of GLP-1/GCG is getting a shoutout for a Phase III in obesity next year, along with a mid-stage program for NASH.
  • The big partnership hope here lies at Myokardia, which is allied with Sanofi on mavacamten, their lead drug for genetically defined cases of cardiomyopathy.

Vaccines

  • After two huge disasters in vaccines in the last few days, Sanofi highlights its work on RSV, but it’s still in Phase II.

R&D chief Zerhouni summed it up:

“2018 will be an important year as we expect multiple milestones for Sanofi’s late-stage pipeline, made possible through the prioritization principles we have consistently applied to our early-stage research programs.”


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