- Novavax shares surged Tuesday morning after the Maryland-based vaccine maker reported positive results from a late-stage study of its experimental influenza vaccine.
- The study, which enrolled patients 65 years and older, found Novavax's NanoFlu drove an immune response that was non-inferior to an already approved flu vaccine marketed by Sanofi. In fact, researchers found that significantly more patients developed flu-fighting antibodies — and did so at higher levels — when given NanoFlu as opposed to Sanofi's Fluzone, according to Novavax.
- Almost half of patients injected with NanoFlu had some kind of treatment emergent adverse event, versus 42% of Fluzone-treated patients. Less than 1% of patients in each arm experienced a serious adverse event. "This looks like a vaccine that has a good safety profile to us," Novavax CEO Stanley Erck said on a Tuesday morning call with investors.
The vaccine market is almost entirely controlled by four pharmaceutical giants: Sanofi, Pfizer, GlaxoSmithKline and Merck & Co. Smaller companies like Novavax have tried breaking in, but vaccine development is a tricky business, hallmarked by expensive research programs and large-scale manufacturing requirements.
Novavax knows the challenges well. Founded in 1987, the company has yet to bring a vaccine to market. It came close with a potential vaccine for respiratory syncytial virus, but a roughly 4,600-patient, late-stage study failed last year, and shares plummeted nearly 70%. Though the company decided to forge ahead with another large study of the vaccine, that trial will take years to complete.
Positive late-stage data for NanoFlu, though, may put Novavax in striking distance of getting its first marketed product. The company intends to ask the Food and Drug Administration for a speedy approval of the vaccine.
If Nanoflu comes to market, it would face direct competition from other so-called quadrivalent flu vaccines sold by Sanofi, GSK and North Carolina-based Sequiris.
Last year, Sanofi's flu vaccine business had net sales of 1.9 billion euros while U.K.-based GSK's rival division reported 541 million pounds worth of sales. The figures reflect a 7% and 1% growth from 2018, respectively, under constant exchange rates.
Novavax shares were up 20% late Tuesday morning, to trade at $12.94 apiece. The company's share price has more than doubled since the start of the year, in part because of the Nanoflu data but also because of a recently forged vaccine program aimed at the novel coronavirus. On Mar. 10, Novavax announced it had received $4 million in initial funding from the Coalition for Epidemic Preparedness Innovations to support the program.
Erck noted on the investor call that the NanoFlu data could be helpful as his company works to develop this vaccine for the new coronavirus, which causes the disease COVID-19, since both would be made with the company's nanoparticle technology platform and used in similar populations.
"Here we have the same platform technology ... and we've got very good safety data compared to another vaccine," Erck said. "I think the key thing is the very, very low rate of what we call severe events. That will be part of the safety database to call upon to move forward with the COVID vaccine, so I think we can make a claim that in a Phase 3 setting, of course along with our Phase 2 data elsewhere, that our vaccine is well tolerated."