NEUVILLE-SUR-SAONE, France - Sanofi expects final clinical results for its vaccine against dengue by late September, the French drugmaker's project leader has told Reuters, and has already gambled on starting production despite some disappointing early trials data.
Sanofi has invested more than one billion euros in the project and is hoping to become the first drugmaker to sell such a shot next year after two decades of research on the world's fastest-growing tropical disease, for which there is no preventative treatment.
Sanofi Pasteur, the French drugmaker's vaccine unit, has made a big industrial bet: it started producing the vaccine last July to keep a lead over competitors and ensure it is ready to ship doses, assuming it finally gets approved by regulators.
The investment highlights the time-consuming and capital-intensive nature of the vaccines business.
Sanofi is upbeat - but based on clinical trial results so far, many analysts believe approval is far from assured. All are waiting for the upcoming data to determine whether the vaccine will be a blockbuster.
"Today we are confident our vaccine can have an impact on public health and we are gearing up for its success," Guillaume Leroy, who heads the dengue vaccine project at Sanofi Pasteur, said in an interview.
Leroy said the results of a final clinical trial on 30,000 children in Latin America and southeast Asia would start trickling in from mid-year. He said as soon as his team could draw reliable preliminary findings it would unveil these.
By the end of the third quarter, Sanofi will have full consolidated clinical results that it hopes to present at a conference on tropical diseases in November.
If the data is positive, Sanofi hopes to sell the vaccine around late 2015 in at least one country affected by the disease, most likely one of the 10 that took part in the trials.
"It's hard to predict which one could be first, but one can easily imagine it'll be one of the bigger countries, such as Brazil, Mexico, Malaysia, maybe the Philippines," Leroy said.
Dengue fever - also known as "breakbone fever" because of the severe pain it can cause - is an infectious mosquito-borne disease that thrives in tropical regions. It infects 50 to 100 million people each year, according to the World Health Organisation - and some experts put the number at triple that level.
Most patients survive dengue but it kills an estimated 20,000 people each year, many of them children.