Triggering a huge after-hours selloff, Gaithersburg, MD-based Novavax reported Thursday that its RSV vaccine candidate flunked a big Phase III trial. The failure of the vaccine, which some analysts have pegged to reach more than $800 million by 2022 sales, wiped 85% away from the biotech’s former $2 billion-plus market cap.
In a Phase III study of 11,856 people 60 and older, Novavax’s ($NVAX) F-protein recombinant nanoparticle RSV vaccine missed its primary and secondary objectives while failing to demonstrate efficacy.
Just this week, the program was pegged as a top 5 vax R&D project worldwide by value from EvaluatePharma analysts, who predicted $846 million in 2022 sales for the vaccine. With the news, Novavax shares plummeted from $8.34 to $1.19 after hours. CEO Stanley Erck said following the data release that the company wouldn’t file a BLA in 2017. The company's shares remained off 85% in early trading today.
The data were “surprisingly flat,” Erck said during a conference call Thursday, going on draw a silver lining in new Phase II data showing that a second annual dose could be “highly effective in preventing acute respiratory disease.” Execs are analyzing ways to move forward.
After R&D chief Gregory Glenn first suggested that a weak RSV season may have impacted the trial, industry-watchers pointed out that in May he said the company wasn’t noticing any abnormalities in the season.
In people 65 and older, respiratory syncytial virus every year causes 207,000 hospitalizations and 16,000 deaths, according to Novavax estimates.
With no marketed products, Novavax is also working to advance the vaccine to protect infants through maternal vaccination, having received an $89 million Gates Foundation grant to test the approach. The biotech is developing vaccines against flu and Ebola, as well, and earlier this year said it’s examining its options in Zika.
Though it's in preclinical stages, EP’s new World Preview 2016 report pegged the biotech's influenza and RSV vaccine combo as the most valuable R&D project in the vaccine industry, projecting 2022 sales of more than $1 billion for the combo.