Sanofi has announced its results for the second quarter 2016, according to which it had €1,158m net income, which represents a change of -11.1%.
In the same period, the company has reported Aggregate Company sales to be €8,868 million, down 4.3% at 2016 exchange rates.
Sanofi Chief Executive Officer, Olivier Brandicourt, commented:
“Our second quarter financial performance was in-line with expectations and reflected anticipated headwinds. Sanofi Genzyme grew 20% and Sanofi Pasteur performed well despite a delay in Dengvaxia uptake. Recent highlights included the signing of the CHC asset swap, the approval of Praluent in several countries and positive Phase III CHRONOS data for dupilumab. Following our first half performance, we confirm our broadly stable 2016 Business EPS guidance at CER.”
Prauletnt in Japan after U.S and EU
In a regulatory update, the company said that in July, the Ministry of Health, Labor and Welfare in Japan granted marketing authorization for Praluent (alirocumab) for the treatment of uncontrolled low-density lipoprotein cholesterol in certain adult patients with hypercholesterolemia at high cardiovascular risk. The 300mg once-monthly dosing of Praluent was also filed in U.S. and EU.
In July, the file for the Marketing Authorization Application for sarilumab in Rheumatoid Arthritis was accepted for review by the European Medicines Agency (EMA).
In May, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the FDA recommended the approval(11) of the New Drug Application (NDA) for Adlyxin® (lixisenatide) and for the fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes. The fixed-ratio combination of basal insulin glargine and GLP-1 receptor agonist lixisenatide is undergoing FDA review, with decisions anticipated in August 2016. Adlyxin® (lixisenatide) was approved in the U.S. at the end of July.
44 pharmaceutical new molecular entities
At the end of July 2016, the R&D pipeline contained 44 pharmaceutical new molecular entities (excluding Life Cycle Management) and vaccine candidates in clinical development of which 14 are in Phase III or have been submitted to the regulatory authorities for approval.