As it works to introduce its dengue vaccine in endemic countries around the world, Sanofi Pasteur this week touted efficacy results from two Phase III studies in a move to help build the case for wide uptake.
In a New England Journal of Medicine data analysis, the candidate demonstrated protection for 66% of patients aged 9 and older against all four dengue serotypes. The shot protected 93% of patients against severe dengue, reduced hospitalizations due to dengue by 80%, protected 82% of those previously exposed to the virus and 52% of those who were naïve to dengue prior to vaccination.
Based on the data, Sanofi Pasteur has recommended the target population of those 9 years and older in endemic countries, "where the combination of disease burden and the vaccine's proven impact profile in this age group point to the greatest potential for reduction of dengue disease burden in these countries," the company's release said.
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| Sanofi's Olivier Charmeil |
The publication comes as the company works to roll out the decades-in-development vaccine, a project on which it has spent about $1.5 billion in R&D. In an interview last week, Sanofi vaccines head Olivier Charmeil said he expects the shot will be available in 20 countries by the end of the year with a total population of 1 billion. All told, Charmeil added, the market potential for the vaccine ranges from 3 to 4 billion people.
That, he said, makes the shot a shoo-in to be on the unit's "high end" of profitability.
Contrary to past vaccine launches, Sanofi Pasteur is looking to endemic countries rather than the traditional markets of U.S. and Europe to recoup its development costs; analysts have predicted the shot to bring in up to €1 billion per year in sales.
According to Sanofi's statement, dengue is endemic in more than 100 countries with nearly half of the world's population; no specific treatment or prevention measures exist currently. By 2020, the World Health Organization aims to lessen mortality due to dengue by 50% and morbidity by 25%.
Also working on a dengue vaccine is Takeda, which could be battling for market share with its DENVax by 2020, analysts have predicted. The shot could feature a more convenient dosing schedule plus competitive pricing to help it fight off Sanofi's first-to-market advantage. Merck ($MRK) and GlaxoSmithKline ($GSK) are further off with their dengue candidates.
- here's the release
- and the abstract