Maria Rosario Capeding, Research Institute for Tropical Medicine

Maria Rosario Capeding
Persevering to prevent a deadly virus

Affiliation: Research Institute for Tropical Medicine
Title: Leader, dengue research program; principal investigator, Sanofi dengue vaccine program

Maria Rosario Capeding isn't actually employed by Sanofi ($SNY), but her importance to the company's vaccines division--and to conquering one of the world's deadliest diseases--cannot be overstated. Capeding, who heads up the department of microbiology and the dengue study group at the Research Institute for Tropical Medicine in the Philippines, led the clinical trials for Sanofi's dengue vaccine. Analysts expect the product will eventually be hauling in sales of $1.4 billion a year from countries where the virus is endemic, including Mexico, Brazil and Colombia.

Capeding, a practicing pediatrician, began working on dengue when she was completing a fellowship in infectious diseases in the 1980s. The disease, transmitted by mosquitoes, fascinated her, Capeding told FierceBiotech. "It was an emerging disease then, and it was of interest to me because it's associated with unpredictability," she said, largely because the disease has four serotypes. "These may all be circulating in a particular region, or they can vary from country to country."

Dengue went on to become one of the world's most vexing epidemics, strengthening Capeding's resolve to join the fight to stop it. According to the World Health Organization, between 50 million and 100 million new cases of dengue strike every year in 100 countries, with the disease causing 20,000 deaths. "It's a major public health problem," Capeding says.

Sanofi spent more than 20 years and $1.5 billion developing its dengue vaccine candidate, recruiting Capeding early on to lead clinical trials involving tens of thousands of children around the world. Most recently, Sanofi completed a study of 10,275 children between the ages of 2 and 14 in Asia, proving that the vaccine reduced the incidence of dengue by 56.6%. Results from a second Phase III study are expected soon, and Sanofi plans to begin filing for regulatory approvals in the first quarter of 2015.

Developing the dengue vaccine has presented a host of challenges, not the least of which is the existence of its four serotypes. Sanofi's vaccine has proven effective against all but one of those--serotype 2, one of Asia's most commonly occurring forms of the disease. In the most recent trial, it fell short of statistical significance, posting just 34.7% efficacy in that serotype. But Capeding isn't concerned. "We always emphasize that all four serotypes are present, they're all circulating. The vaccine has a good [overall] efficacy rate--it reduces the severity of the disease and the risk of hospitalization."

Capeding's passion for the dengue vaccine program is largely personal. Her eldest son, now a medical intern, is a dengue survivor. Experiencing the disease up close only drove home the importance of distributing the vaccine in countries that need it. "Even though I'm a doctor and an infectious disease specialist, I was still anxious," she says. "I worried he would go into shock from his fever. As a mother, I share that anxiety among all parents. As a clinician, as a mother, I can say this vaccine is very important."

For more:
Sanofi dengue vaccine filings could come as soon as next year's Q1, CEO says
Solid PhIII brings Sanofi closer to blockbuster dengue sales
Sanofi's $1.5B dengue vaccine shows Phase III promise, but questions linger

-- Arlene Weintraub (email | Twitter)

Maria Rosario Capeding, Research Institute for Tropical Medicine
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