Sanofi-Aventis starts work on dengue fever plant
pharmafile | May 15, 2009 | News story | Manufacturing and Production |Â Â Sanofi-AventisÂ
Sanofi-Aventis' vaccine subsidiary Sanofi Pasteur has broken ground on a 350 million euro facility devoted to the producing a vaccine for dengue fever, the mosquito-transmitted viral infection endemic in more than 100 countries around the world.
The plant is being constructed in Neuville-sur-Saone, a town near the French city of Lyon, and is due to start production in 2013, turning out 100 million vaccine doses a year when fully operational.
It is "the largest investment ever made by Sanofi-Aventis," said chief executive Chris Viehbacher, and brings the company's total investment in vaccines production to 1 billion euros since 2005.
The scale of the investment reflects the seriousness of dengue fever as a global health concern.
The World Health Organisation currently estimates there are around 50 million dengue infections worldwide every year, with the incidence growing dramatically in recent decades.
In a proportion of cases those infected develop a serious complication – dengue haemorrhagic fever (DHF) – a major cause of illness among children in affected countries and has a death rate of around 2.5%, rising to 20% if no proper treatment is available.
There is currently neither a vaccine or a specific treatment for the virus. Healthcare workers tend to manage the illness with supportive care, such as making sure patients' fluid levels are kept up.
One of the challenges in developing a dengue fever vaccine is that it is caused by four closely-related but antigenically-distinct viruses in the Flavivirus genus. Immunity to one type does not protect against subsequent infection against another, so vaccines have to tackle all four to be effective.
Sanofi-Aventis is at the forefront of efforts to develop a vaccine, and has a live, attenuated candidate in the US, in phase II trials. Studies to date have shown that a three-dose immunisation regimen stimulates a neutralising antibody response against all four virus types in 100% of patients. The company is hoping to launch its vaccine in 2015/16.
GlaxoSmithKline is also developing a live attenuated candidate with a two-dose regimen in phase II trials, with the help of the Walter Reed Army Institute of Research (WRAIR).
Meanwhile, the US National Institutes of Health are developing both live vaccines and a chimeric vaccine – in which elements from the dengue virus are joined to elements from yellow fever virus – in early-stage clinical trials, and WRAIR has ongoing early-stage trials of a DNA-based dengue vaccine.
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