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 Sanofi has invested more than 1.3 billion euros ($1.7 billion) in
the project, undertaking two decades of research on the world's
fastest-growing tropical disease.
The final study - conducted on 20,875 children aged 9-16 across five
countries in Latin America - confirmed that the vaccine was safe,
provided high protection against dengue hemorrhagic fever and cut by
80 percent the risk of hospitalization, the Paris-based company said
on Wednesday.
It was 42.3 percent efficient in tackling serotype 2, one of the
viral disease's four strains, compared to 35 percent in a previous
Asian trial on some 10,000 children, a relatively weak rate that has
puzzled scientists. [ID:nL6N0PM1OV]
Overall, the findings were consistent and more reliable in the Latin
American trial as it had twice as many patients as the Asian trial,
said Nicholas Jackson, head of dengue research and development at
Sanofi's vaccines unit Sanofi Pasteur.
"We're talking about different regions, different seasons, different
demographics, and it's very important for a vaccine to perform
consistently, so these results are extremely pleasing," he told
Reuters in an interview.
The study was conducted in Brazil, Colombia, Mexico, Honduras and
Puerto Rico. Sanofi will unveil its detailed findings at the
American Society of Tropical Medicine and Hygiene's annual meeting
at the beginning of November.
As in Asia, the results suggested the new vaccine acts best as an
immune booster for patients with some previous exposure, and
therefore may be most useful in tropical regions where dengue is
common, rather than as a vaccination for tourists.
However, given how the vaccine drastically reduces the most severe
cases of dengue - by close to 90 percent - many countries and
patients including tourists could see the point in using it, said
Guillaume Leroy, head of Sanofi's dengue vaccine project.
He said Sanofi aimed to start filing regulatory applications for the
vaccine early next year and ultimately reach out to 100 countries,
but that it would target as a priority the countries where it led
the trials.
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Chief Executive Chris Viehbacher said in July that Mexico, Brazil
and Colombia could be the first to market the vaccine.
The first batches - produced at a dedicated plant outside Lyon in
southeastern France - will be ready next year and Sanofi aims to
sell the first doses in the second half of 2015.
Some analysts believe the three-dose vaccine could bring in 1
billion euros ($1.31 billion) a year, significantly boosting
Sanofi's vaccines business, which generated sales of 3.7 billion
euros in 2013.
Leroy said Sanofi would apply for regulatory approval on a
three-dose regimen to maximize the body's immune response to the
jab, but declined to comment on pricing and sales estimates.
Nearly half the world's population is at risk of contracting dengue
fever - also known as "breakbone fever" because of the severe pain
it can cause. The disease infects some 100 million people each year,
according to the World Health Organization, and some experts put the
number at three times that level.
Most patients survive dengue but it kills an estimated 20,000 people
each year, many of them children, and causes one hospitalization
every minute around the globe.
(1$= 0.7618 euro)
(1 US dollar = 0.7616 euro)
(Editing by Keiron Henderson)
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