Ahead of a presentation to the financial community on December 10, Sanofi announced Monday that it is halting research into diabetes and cardiovascular (CV) treatments, and will not pursue plans to launch the long-acting GLP-1 receptor agonist efpeglenatide. The company said it would instead focus growth efforts on Dupixent (dupilumab) and vaccines, while also highlighting several potentially "practice changing" therapies in its pipeline. "Additional core drivers include treatments for oncology, haematology, rare diseases, neurology, and [our] strong presence in China," Sanofi added.
New CEO Paul Hudson, who earlier in the day announced that Sanofi had bolstered its immuno-oncology pipeline with the purchase of Synthorx and its IL-2 variant THOR-707 for $2.5 billion, said the "new strategy positions [us] to achieve breakthroughs with our most promising medicines." He admitted it is "getting more difficult to get breakthrough innovation and we have to be efficient and move our resources to areas of opportunity," adding that "to be out of CV and diabetes is not easy for a company like ours…[but] as tough a choice as that is, we're making that choice."
Sanofi noted that "efficiency initiatives", which are expected to generate €2 billion ($2.2 billion) in savings by 2022, will come in large part from limiting spending on the de-prioritised diabetes and CV businesses. The company is also looking to "optimise the commercial model" for the diabetes, CV and rheumatoid arthritis segments, including "right-sizing" the resources deployed behind the PCSK9 inhibitor Praluent (alirocumab) and rheumatoid arthritis therapy Kevzara (sarilumab), both of which are partnered with Regeneron Pharmaceuticals. Further, while it remains committed to completing ongoing studies for efpeglenatide, Sanofi said it will be searching for a partner who can take over and commercialise the type 2 diabetes drug candidate.
Meanwhile, the company's operations will be structured around three business units, including specialty care, vaccines and general medicines. Speciality care will encompass immunology, rare diseases, rare blood disorders, neurology and oncology, while general medicines will group together diabetes, CV and established products.
Consumer healthcare will operate as a standalone business unit with integrated R&D and manufacturing functions, the goal being to grow "faster than the market over the mid-term," according to Hudson. He also indicated that Sanofi would be moving to have the erectile dysfunction drug Cialis (tadalafil) and the influenza medicine Tamiflu (oseltamivir) available over-the-counter (OTC), saying "the new standalone structure, coupled with plans to accelerate the OTC switches for Cialis and Tamiflu, will position the business well to accomplish this ambition."
Looking ahead, the drugmaker is predicting "strong growth" for Dupixent, a dual inhibitor of IL-4 and IL-13 also partnered with Regeneron, with peak sales expectations of more than €10 billion ($11.1 billion) as a result of its "unique mechanism of action targeting the type 2 inflammation pathway." The drug, which generated €570 million ($631 million) in the third quarter, is already approved for atopic dermatitis, asthma and nasal polyps that result in chronic sinusitis. Meanwhile, vaccines are expected to deliver a mid-to-high single-digit net sales through to 2025, via differentiated products, market expansion and new launches.
In regards to its pipeline, Sanofi indicated that it has high hopes for six drug candidates in areas of high unmet need. These include the RNAi therapeutic fitusiran that could potentially allow for the treatment of haemophilia A and B, with or without inhibitors, via a once-monthly dosing schedule, while the factor VIII therapy BIVV0013 is designed to extend protection from bleeds with once-weekly prophylaxis dosing for patients with haemophilia A.
Sanofi noted that the oral therapy Venglustat (ibiglustat), which is being developed for several rare lysosomal storage disorders such as Gaucher disease type 3, Fabry disease and Tay-Sachs disease, is also showing promise for more common disorders including autosomal dominant polycystic kidney disease and some subtypes of Parkinson's disease.
The company also highlighted a selective estrogen receptor degrader, dubbed SAR439859, that "aims to be the new standard of care in HR-positive breast cancer." Further, it says nirsevimab is a potentially cost-effective prevention against respiratory syncytial virus, while the experimental BTK inhibitor SAR442168, an oral drug for multiple sclerosis, could end up being the "first disease-modifying therapy to address inflammation and disability drivers in the brain."
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