By Sara Gilgore – Staff Reporter, Washington Business Journal
As Novavax Inc. continues to push its flu and RSV vaccine candidates through clinical trials, the Gaithersburg biotech is inching closer to both finish lines, expecting new data within a few months.
And, as Novavax (NASDAQ: NVAX) CEO Stanley Erck said on a Wednesday earnings call, “We are preparing for success.”
The company is now three to four months away from reporting results for its two lead vaccine programs. For both — heavily watched vaccine candidate NanoFlu, completing phase 2 trials, and RSV vaccine candidate ResVax, in the homestretch of phase 3 efficacy trials — the company expects results in the first quarter of 2019.
It’s familiar territory for Novavax, though the last time it reached this stage, in September 2016, a failed phase 3 clinical trial for a previous RSV vaccine candidate for older adults proved devastating. It has since pivoted to focus more on its infant RSV and flu vaccines. NanoFlu had promising trial data earlier this year and started its phase 2 study in September, before fully enrolling the trial in October. Novavax also met with the Food and Drug Administration earlier this year, when the agency agreed an accelerated approval pathway could be applied to the flu vaccine.
Now, Erck said, the company is taking steps “to enable us to launch our products as soon as possible post licensure” in the areas of manufacturing quality, regulatory discussions, pre-commercial activities, and partner conversations “to help us leverage the infrastructure of big pharma and accelerate the process of setting up global manufacturing, distribution, sales and marketing.
Here’s what the company says it needs to do: