- Sanofi announced a "voluntary departure program" to reduce its R&D departments in France and Germany by 466 workers, as it shifts away from cardiovascular drug development and toward activities in immuno-oncology and rare diseases.
- The Paris-based pharma will seek to expand its biologics capability and singled out gene therapy as an area of focus. Gene therapy investments will increase in France and the U.S., while antibody engineering in Germany will get additional money.
- Sanofi saw shrinking sales and profit last year thanks in part to the loss of market exclusivity of its flagship drug, Lantus, and so far has missed out on some key developments in oncology and rare diseases.
Sanofi has historically been strong in therapeutic areas that are increasingly under pressure. Long-acting insulin Lantus and blood-thinner Plavix (clopidogrel) once were among the biggest selling drugs in the world, but have lost market exclusivity in recent years.
Efforts to replace them with novel diabetes and cardiovascular assets have been stymied as development in these fields has become increasingly expensive and demanding, while payers are asking for evidence that expensive new drugs are worth the money. Praluent (alirocumab), for example, has been subjected to significant cost cuts since it launched in 2015.
Sanofi therefore is going where the money is, toward immuno-oncology and rare diseases, where biologics and gene therapies play a big role. Its oncology work is heavily tilted toward expanding indications for marketed PD-1 antibody Libtayo (cemiplimab), along with experimental agent isatuximab in multiple types of blood cancers.
However, in Phase 1 development it has eight novel oncology agents, many of which are trying to use immune pathways to treat cancer.
Through its acquisition of Genzyme in 2011, Sanofi has a strong presence in rare diseases. The Genzyme business unit is growing steadily, recording 5% growth in 2018 at constant exchange rates. The big products from that division are under threat from gene therapy, however, as companies like AvroBio try to develop one-time treatments for Fabry and Gaucher disease to compete with Genzyme's enzyme replacement therapies.
Likewise its acquisition of Bioverativ in 2018 provided it with established hemophilia drugs in Eloctate and Alprolix, but these factor replacement therapies could face competition from gene therapies in the near future, as BioMarin Pharmaceutical and UniQure have agents nearing regulatory submission.
Sanofi is testing two rare blood-disease projects in Phase 1, zinc finger nuclease gene-editing treatments being developed for sickle cell disease and beta thalassemia. Its one hemophilia candidate is a long-acting Factor VIII replacement therapy.
The company said it is not retreating completely from cardiovascular disease and diabetes, stating it "would continue to work with its partners to advance important diabetes and cardiovascular programs and support its product portfolio in mature and emerging markets."
This should come as some relief to partners like Regeneron Pharmaceuticals and Lexicon Pharmaceuticals, who are Sanofi's respective collaborators on Praluent and the diabetes pill Zynquista (sotagliflozin).
Specifically in diabetes, Sanofi said it wants its future research to focus on the underlying causes of disease.
Like many big pharma companies with one or two big products, Sanofi has struggled to replace those lost sales when they lose patent protection. Thursday's announcement is a sign that its executives recognize it can't continue to do business the way it has. They may be late gearing up in immuno-oncology and gene therapy, and should be hoping they aren't too late.