Sanofi aims to file nine marketing applications over next 18 months

Sanofi on Wednesday said at an analyst meeting that it plans to make nine regulatory submissions over the next 18 months, while at least 10 pivotal Phase III studies will start in the next 12 months. CEO Olivier Brandicourt remarked "we are making good progress overall on our roadmap and I am confident that Sanofi now is much better positioned to deliver the sustained and long term growth that our shareholders are expecting from us."

According to the company, planned regulatory filings in the next 12 months include the cancer drug isatuximab, sotagliflozin for type 1 diabetes and a potential treatment for uncontrolled, persistent asthma, dupilumab. Sanofi also plans to seek approval of cemiplimab, after separately reporting on Wednesday, along with partner Regeneron Pharmaceuticals, positive data from a Phase II study of the PD-1 inhibitor in patients with advanced cutaneous squamous cell carcinoma.

Sanofi noted that its drug development pipeline spans 71 projects, which includes 37 new molecular entities and novel vaccines. The drugmaker indicated that pivotal studies scheduled to begin in the next year include dupilumab in chronic obstructive pulmonary disease and eosinophilic esophagitis, the once-weekly GLP-1 agonist efpeglenatide for type 2 diabetes, Lemtrada (alemtuzumab) in primary progressive multiple sclerosis and cemiplimab in first-line non-small-cell lung cancer. In addition, planned pivotal trials include venglustat in autosomal dominant polycystic kidney disease and a GLP-1/GCG dual agonist for obesity.

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The company noted that its new R&D model is based on three key strategic shifts: from small molecules to biologics; from mono-targeting to multi-targeting compounds; and from licensing to proprietary assets. "We aim to advance multi-targeting therapeutic approaches for core disease pathways that have the potential to attack more than one disease at a time or bring improved risk benefit in the treatment of a single disease," commented Elias Zerhouni, global head of R&D.

In 2015, Sanofi outlined a five-year strategic plan, which would see six key launches likely to generate peak sales of 12 billion euros ($14.1 billion) to 14 billion euros ($16.4 billion) by 2025. However, one of the products, Dengvaxia, has been hit by safety concerns, with the Philippines recently ordering the suspension of sales of the dengue vaccine. Dengvaxia has been forecast to generate annual sales in excess of $1 billion, although initial revenue last year was 55 million euros ($64.6 million).

Sales of Sanofi's PCSK9 inhibitor Praluent (alirocumab) have also come in below expectations, hit by hurdles to patient access from health insurers and pharmacy benefit managers. "When I turn to delivering outstanding launches I concede that our record over the past two years has been mixed," Brandicourt said, adding "while we are not changing our ambition of combined peak sales, we are clearly much more reliant on our immunology franchise."

Brandicourt also said that the company is on "on track" to sell its European generic drugs unit in "the coming year." Sanofi indicated in 2016 that it plans to divest the business within the next year or two.

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