Sanofi SA (SAN.FR) said Wednesday that it expects a negative impact of 100 million euros ($118.8 million) on its fourth-quarter after-tax profit after updating information on its dengue vaccine Dengvaxia.
The company will ask regulators to update the product label on Dengvaxia after long-term trial data found differences in vaccine performance based on prior dengue infection.
The trial results found that for people who hadn't previously been infected by dengue, vaccination would make the disease worse should they subsequently become infected. For those who had previously contracted dengue, data showed that Dengvaxia provided persistent protection.
Sanofi will propose that health authorities update the prescribing information to request that health-care professionals assess the likelihood of prior infection in an individual before vaccinating. For those who have not been previously infected by dengue virus, vaccination should not be recommended, it added.
The company will record a charge in its fourth-quarter results reflecting depreciation of inventories, as well as accelerated depreciation of some assets, it said. Sanofi said it nevertheless confirms its guidance for "broadly stable" after-tax earnings per share in 2017.
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(END) Dow Jones Newswires
November 29, 2017 12:46 ET (17:46 GMT)