Industry Watch [to 8 November 2014]
Selected media releases and other selected content from industry.
:: The New England Journal of Medicine Publishes Results of Final Landmark Phase III Efficacy Clinical Study of Sanofi Pasteur’s Dengue Vaccine Candidate
– Study successfully met primary objective and confirms high efficacy against severe dengue and hospitalization
– Sanofi Pasteur intends to file for registration in several endemic countries in 2015 –
– Dengue vaccine candidate would address an urgent unmet medical need in tropical and sub-tropical regions of the world
3 November 2014
[Excerpt]
…Sanofi Pasteur’s phase III efficacy clinical study program for its dengue vaccine candidate was conducted in over 31,000 participants across 10 endemic countries in Asia2 and Latin America. Sanofi Pasteur will file for registration of its vaccine candidate and, subject to regulatory approval, the world’s first dengue vaccine could be available in the second half of 2015.
“We plan to submit the vaccine for licensure in 2015 in endemic countries where dengue is a public health priority,” said Olivier Charmeil, President and CEO of Sanofi Pasteur. “We are committed to supporting countries’ ambitions to significantly impact the human and economic
burden of dengue through comprehensive vaccination programs. Our goal is to help meet the WHO’s objectives to reduce dengue mortality by 50% and morbidity by 25% by 2020.”…
… Sanofi Pasteur is already producing the vaccine in a newly dedicated production facility in Neuville-sur-Saône, France, which will be capable of providing timely supply of large quantities of vaccines to meet the global public health demand…

:: Sanofi Pasteur Announces FDA Approval of Updated Prescribing Information for Fluzone High-Dose Vaccine for Adults 65 and Older
Includes New Data Showing Fluzone High-Dose Vaccine More Efficacious Than Standard-Dose Fluzone Vaccine –
SWIFTWATER, Pa., Nov. 3, 2014 /PRNewswire/ — Sanofi Pasteur, the vaccines division of Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental biologics license application (sBLA) for Fluzone® High-Dose (Influenza Vaccine) to include efficacy data in the Prescribing Information. These data demonstrate that Fluzone High-Dose vaccine provided improved protection against influenza (“the flu”) compared to standard-dose Fluzone vaccine (trivalent intramuscular formulation) in adults 65 years of age and older.
The Prescribing Information for Fluzone High-Dose vaccine now includes data from a large-scale, multi-center efficacy and safety trial published in the August 14, 2014, issue of The New England Journal of Medicine (DOI: 10.1056/NEJMoa1315727).[i]…