French pharma hit by Philippine scandal
French pharmaceutical manufacturer Sanofi is relying on new products to stimulate growth as it battles falling sales of its major insulin drug and controversy in the Philippines over its dengue vaccine which was given to more than 830,000 children.
The firm said it had nine regulatory submissions planned for the next year and a half, including two cancer drugs, one for type 1 diabetes and a drug for uncontrolled, persistent asthma.
Sanofi is under pressure to make breakthroughs in research and development after its highly profitable diabetes drug, Lantus, lost its US patent protection and now faces cheaper rivals. Its new cholesterol drug, Praluentas, has also seen lacklustre sales.
Olivier Brandicourt, Sanofi’s CEO, said he was “confident” its new products would be “the foundation for Sanofi’s future long-term growth”.
Pressure is also growing on Sanofi in the Philippines over safety concerns over its Dengvaxia dengue vaccine.
Sanofi had recommended that the vaccine only be given to children older than eight in areas where dengue was widespread.
Last week Manila’s health regulators suspended sales of Dengvaxia, which has been used in children in the world’s first mass immunisation programme against dengue fever.
In November Sanofi confirmed the vaccine could increase the risk of severe dengue in some cases where a patient had not been previously exposed to the disease.
The Philippines’ health ministry said the government planned to sue the pharmaceutical company.
But Brandicourt said the firm had no litigation budget for Dengvaxia. “We are not into any litigation yet and there is no indication that there will be,” he added.
The decision follows Sanofi’s warning that the vaccine could lead to severe infections in some cases, which sparked alarm in the archipelago, where dengue is common.
In Sanofi’s trials, blood samples were not collected from all the children before they were vaccinated, which would have identified prior exposure to dengue by showing the presence of antibodies.
It has also been reported that before Sanofi’s vaccines division, Sanofi Pasteur, won the Philippine contract to supply Dengvaxia, it had already imported stocks of its vaccine.
Sanofi Pasteur’s Asia-Pacific boss Thomas Triomphe told French MPs that 200,000 vials, around 1 million doses, were exported to the Philippines by January 2016. Sanofi won the contract six weeks later.
Sanofi said it anticipated its net income for the fourth quarter to fall by €100 million after the Dengvaxia debacle but expected 2017 earnings per share to be stable.
Sanofi’s Frankfurt depot. Picture credit: Wikimedia