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Sanofi: nine new applications of treatments by 18 months

Sanofi plans to submit nine new treatment applications to the various regulatory agencies during the next 18 months, the group announced Wednesday at a conference with analysts.

The pharmaceutical giant has also indicated preparing the launch of "at least" 10 Phase III studies (the final step before a marketing authorization application) in 2018.

With 71 research and development projects and 37 new products currently under consideration, General Manager Olivier Brandicourt welcomed a "busy" schedule for the coming years.

Mr. Brandicourt has pointed to improvements in the productivity of research and development in recent years, stating that Sanofi has moved from a "lagging industry" in 2011 to one that "exceeds" the industry average in 2016.

In the near future, the group is particularly focused on Dupixent (dupilumab), a product in immunology developed with the American Regeneron, a "major commercial opportunity" according to Mr. Brandicourt.

This treatment against eczema, sold in the United States since the spring and authorized in Europe since late September, reported 75 million euros on the third quarter 2017.

To boost it, the laboratory plans to obtain new indications, first against severe asthma since Sanofi will submit a request within a month, then against nasal polyposis (a form of sinusitis) early 2019. It also plans to extend the indication against eczema to adolescents, who are now excluded. In the longer term, Sanofi would also like to prescribe it against eosinophilic esophagitis and food allergies.

In oncology, where the group is still not very present, Sanofi plans to submit three applications for a biological product license and a Marketing Authorization (MA) in 2018.

These include cemiplimab, a PD-1 checkpoint inhibitor that needs to treat some form of skin cancer.

Sanofi unveiled on Wednesday the first positive results of its pivotal study and said plans to file applications in the United States and before the European Medicines Agency in the first quarter 2018.

In September, in the United States, the US Food and Drug Administration (FDA) granted historic breakthrough status to this treatment.

During this presentation, the group recalled the three pillars of its strategy in research and development: focus on biological agents to chemical molecules, multiply the indications for each molecule and promote the activities of which Sanofi has ownership in place of licenses.

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The A3P Association is a major player in the pharmaceutical and biotechnology industry.
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