Sanofi said it expects to take a fourth-quarter charge “in the range of €100 million” ($118.5 million) to reflect lowered projected sales for its pioneering dengue vaccine Dengvaxia® after long-term clinical trial data showed the vaccine could increase the severity of the disease in people who were not previously infected.

Sanofi cited an analysis of six years of clinical data for its revised finding that Dengvaxia—the world’s first approved vaccine for dengue—performed differently in patients based on whether they had been previously infected with dengue.

Dengvaxia provides “persistent” protective benefit against dengue in patients who were previously infected with the disease, Sanofi said. But longer-term, in previously uninfected patients, the analysis found that more cases of severe disease could occur following vaccination.

“These findings highlight the complex nature of dengue infection,” Su-Peing Ng, M.D., global medical head, Sanofi Pasteur, said yesterday in a statement. “We are working with health authorities to ensure that prescribers, vaccinators, and patients are fully informed of the new findings, with the goal of enhancing the impact of Dengvaxia in dengue-endemic countries.”

To that end, Sanofi said, it will ask regulatory agencies to update the prescribing information for Dengvaxia by adding a request that healthcare professionals evaluate the likelihood of prior dengue infection in patients before vaccination. Sanofi’s revised label will no longer recommend vaccination in patients who were previously uninfected by dengue virus—but will instead limit its recommendation of the vaccine to patients in countries with high burden of dengue disease where potential benefits outweigh the potential risks.

The World Health Organization has cited a 2013 study that estimated 390 million dengue infections annually, with data from some countries where the disease is endemic showing that by adolescence, between 70% and 90% of people will have been exposed to dengue at least once.  

According to Sanofi, Dengvaxia has been shown to prevent 93% of severe disease and 80% of hospitalizations due to dengue over the 25-month phase of the large-scale clinical studies conducted in 10 countries in Latin America and Asia where dengue is widespread.

Lower Sales Likely

The more restrictive label will likely lower sales of Dengvaxia, which were just €22 million ($26 million) during the first nine months of 2017, down 56% from January–September 2016. For all of 2016, Sanofi racked up €55 million ($65 million) in net sales of Dengvaxia.

Those numbers are a far cry from the €200 million ($237 million) in 2016 sales Sanofi once estimated for Dengvaxia, which took two decades and some $1.5 billion in development costs before gaining approval after positive Phase III results. The pharma giant retreated from that forecast halfway into last year, blaming political changes and economic volatility in Latin America.

Consensus analyst forecasts reported by Thomson Reuters call for about €360 million ($428 million) in annual sales by 2022—still well short of the blockbuster sales forecasts once predicted for the dengue vaccine before its commercial launch more than a year ago.

Sanofi said it would take its charge against “business net income,” a non–generally accepted accounting principles (non-GAAP) measure that consists of net income excluding amortization and impairment of intangible assets, restructuring costs, impacts of acquisitions, taxes on dividends, and other factors.

Despite the planned charge, Sanofi affirmed its November 2 guidance to investors of a “broadly stable” 1.1% increase in business earnings per share at constant exchange rates in 2017 versus 2016, barring unforeseen major adverse events.

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