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Sanofi : may seek U.S. approval for Dengvaxia despite Philippines outrage

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03/08/2018 | 05:58pm CEST
FILE PHOTO:French multinational pharmaceutical company SANOFI logo is seen at the headquarters in Paris

(This version of Mar.7's story corrects timeframe of filing decision in the United States in bullet point and paragraphs 10-11.)

PARIS (Reuters) - French pharmaceuticals group Sanofi says it will decide shortly whether to seek regulatory approval for dengue vaccine Dengvaxia in the United States, saying it was committed to the medicine despite a health scare in the Philippines.

David Loew, the head of Sanofi Pasteur, the group's vaccines division, said the company had complied with all regulations and had no regrets about the vaccine, Dengvaxia, was developed despite the Philippines suspending a vast government immunisation programme because of safety concerns.

"On the whole path of development, we always worked with the WHO and experts in the dengue community. We were always transparent," Loew told Reuters in an interview, referring to the World Health Organization and other regulators.

"You need to ask yourself: what was done with the information that was available at the time? Looking back, I would say no, we would not have done anything differently."

Loew said the company was contemplating the possibility of filing an application for the use of Dengvaxia in the United States and that a meeting with the Food and Drug Administration would take place within two months.

Any decision would be taken after the meeting, he said.

Some experts have argued Sanofi and regulators may have ignored warnings about how the vaccine was developed, but executives at Sanofi denied any errors.

Dengvaxia has been approved and registered in 19 countries, mostly in the developing world. It is currently under review by the European Medicines Agency.

(Reporting by Matthias Blamont; editing by Luke Baker)

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Financials (€)
Sales 2018 35 273 M
EBIT 2018 8 334 M
Net income 2018 5 099 M
Debt 2018 15 707 M
Yield 2018 4,46%
P/E ratio 2018 16,28
P/E ratio 2019 15,21
EV / Sales 2018 2,86x
EV / Sales 2019 2,71x
Capitalization 85 245 M
Duration : Period :
Sanofi Technical Analysis Chart | SAN | FR0000120578 | 4-Traders
Technical analysis trends SANOFI
Short TermMid-TermLong Term
Income Statement Evolution
Mean consensus OUTPERFORM
Number of Analysts 27
Average target price 77,0 €
Spread / Average Target 14%
EPS Revisions
Olivier Brandicourt Chief Executive Officer & Director
Serge Weinberg Chairman
Jérôme Contamine Chief Financial Officer & Executive VP-Finance
Elias A. Zerhouni President-Global Research & Development
Ameet Nathwani Executive Vice President-Medical Affairs
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