Novavax details 'pre-commercialization activities,' $1.5B sales target for RSV vaccine

Novavax may be years away from a potential approval of its RSV vaccine, but on the company's recent year-end conference call, executives talked up the candidate's commercial appeal and the steps they're taking now to prepare for a possible rollout. 

Newly named chief business and financial officer John Trizzino told analysts on the company's fourth-quarter call the shot could bring in $1.5 billion at peak "before we even consider the potential in middle income markets and the benefit to low-income countries." The biotech estimates peak U.S. sales at $750 million, he said on the call. 

Novavax is testing the shot as a maternal immunization to protect infants in a phase 3 study in 11 countries around the world. It's hoping to complete an interim analysis by early next year and file for approval in late 2019 or early 2020, according to an accompanying presentation. 

But even as the study progresses, Novavax is working with policymakers and key opinion leaders to prepare for a potential launch. Trizzino said both are "foundational pieces to our pre-commercialization activities." 

"Our RSV vaccine for infants via maternal immunization will be administered to pregnant women in their third trimester, and so the OBGYN physicians must understand the benefits of these vaccines for their patients," he said on the call. "Novavax is already working with ACOG, the American College of Obstetricians and Gynecologists, to support educational programs for RSV and maternal immunization."

Further, the biotech has communicated with the CDC and its experts, plus RSV groups "in support of gathering information about epidemiology, surveillance and economic burden," Trizzino said.

Currently, there are no approved RSV vaccines and no vaccines approved to protect infants during a mother's pregnancy. The Bill & Melinda Gates Foundation is helping fund the work through an $89 million grant.  Under that grant, Novavax has agreed to supply the vaccine at "affordable pricing to people in certain low and middle income countries," according to the company's website.

In slides accompanying the conference call, the company said an informational analysis of 1,307 infants observed a vaccine efficacy between 45% and 100%. Based on that analysis, the company continued enrollment into this year, according to a December press release. 

Novavax had big hopes for the vaccine in another population, adults 60 and older, but in September 2016 reported a phase 3 trial failure that wiped more than 80% off its share prices. The stock still hasn't recovered, only climbing modestly as the company pushes ahead in RSV, Ebola, Zika and flu. 

The biotech is still testing its RSV vaccine in a phase 2 study in the 60 and older population, according to its online pipeline, as well as in children ages 6 months to 5 years in a phase 1 test.

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