After 20 years in the lab and $1.4 billion in R&D costs, Sanofi's ($SNY) in-development dengue fever vaccine is on the verge of regulatory applications, and, despite a few clinical hiccups, the drugmaker told Reuters it believes it has a blockbuster on its hands.
If approved, Sanofi's treatment would be the only vaccine on the market for an often deadly tropical disease that infects up to 100 million people a year, according to the World Health Organization. Sanofi is working through a Phase III trial around the globe, expecting to rack up final data in the third quarter and, if they're positive, start selling the vaccine in late 2015, the company told Reuters.
If all goes according to plan, analysts expect the shot to bring in about $1.4 billion a year at its peak, and Sanofi's so confident in its dengue candidate that it already shelled out nearly $1 billion to set up a plant dedicated to producing the vaccine, Reuters notes.
But not everyone is so bullish. Dengue developers have long struggled to account for the virus' many serotypes, and, in results from a Thai trial released in 2012, Sanofi's candidate failed to protect against that country's most common strain. Proving efficacy across a wide range of dengue subtypes will be difficult, but, considering the unmet need and Sanofi's first-mover status, many analysts figure the vaccine is likely to make its way to market eventually.
However, its impact on the company's revenue will largely be tied to its pricing, which Citi's Peter Verdult told Reuters will likely end up somewhere between $10 and $50 per shot for the three-dose regimen. Sanofi has funded studies finding that its vaccine is cost effective at up to $100 a pop, but Verdult doubts the drugmaker can get away with that price unless the treatment aces its Phase III efficacy endpoints in all four of dengue's strains.
Meanwhile, competitors including GlaxoSmithKline ($GSK), Merck ($MRK) and Novartis ($NVS) are hammering away at dengue vaccines of their own, but none has made its way into Phase III, Reuters notes.
Sanofi is looking to its growing vaccines unit to help reverse a recent slump in product launches, and, in tandem with its vaunted dengue program, the company is in the midst of late-stage studies for a first-of-its-kind Clostridium difficile shot with data expected in 2017. Separately, Sanofi has set its sites on Pfizer ($PFE) and the multibillion-selling Prevnar 13, last week signing a deal with South Korea's SK Chemicals to team up on a competing pneumococcal conjugate vaccine.
- read the Reuters story