The road to approval has been a long and costly one for Sanofi's ($SNY) dengue fever candidate, which is on the verge of regulatory applications after 20 years in the lab and more than $1.4 billion spent on R&D. Now, with over $1 billion in yearly sales potentially on the line, the pharma giant has forged a new collaboration to help assess the jab's postintroduction effectiveness.
The University of Pittsburgh's Center for Vaccine Research (CVR) will develop a test to determine whether a person's immunity following vaccination stems from a previous natural infection--such as an asymptomatic, "silent" case of dengue--or from Sanofi's shot itself. For every case of the virus, three of these silent cases can go unnoticed, Nicholas Jackson, Sanofi's head of dengue R&D, said in a statement.
"Distinguishing whether a person's immune response is from the vaccine or from infection by a mosquito can play an important role in the assessment of a candidate vaccine," Dr. Ernesto Marques, an associate professor of infectious diseases and microbiology at CVR, said in a statement.
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| Associate Professor Ernesto Marques, CVR |
Sanofi's vax is currently moving through a global Phase III trial, and the company told Reuters last month that it expects to round up final data in the third quarter. Assuming those data are positive, the vaccine could hit the market in late 2015, the drugmaker said.
That market is a lot bigger today than it was when Sanofi began work on the vaccine. Back in the 1990s, the World Health Organization (WHO) reported an average of 295,000 dengue fever cases per year. Today, the often deadly tropical virus--which currently lacks a vaccine to ward it off--threatens more people than ever before, affecting up to 100 million people a year.
Sanofi has done its best to get there first, racing past competition from GlaxoSmithKline ($GSK), Merck ($MRK), Novartis ($NVS) and Takeda. And while the wannabe blockbuster's record isn't perfect in clinical trials--a September 2012 study showed just 30% overall efficacy against dengue fever type 2, one of four virus types the vaccine is meant to protect against--many analysts believe it will see its way to market, generating $1.4 billion a year at its peak.
- read the release