Novavax isn’t letting a bruising phase 3 failure for its RSV vaccine kill its enthusiasm around the program. In fact, management still figures the biotech leads its much larger competitors in a lucrative field.
Despite a phase 3 failure for the RSV F vaccine in older adults last September, Novavax CEO Stanley Erck said on Monday that his company still expects “to enjoy the advantage of being the first RSV vaccine in the market.” Speaking on a fourth-quarter conference call, Erck added that Novavax continues “to believe that there is a multibillion-dollar opportunity” for the vaccine.
That’s even after the shot missed its primary and secondary objectives in a phase 3 trial and failed to demonstrate efficacy last fall. Shortly after releasing those results, which sent shares steeply downward, the company chopped 30% of its workforce in a move to trim $100 million in expenses for this year.
After that trial failure, analysts at EvaluatePharma dropped their 2022 sales projection for the shot to $549 million, down from $845 million.
Analysts have been mixed on the importance of the failed trial. Speaking about the results last fall, analyst Heather Behanna at Wedbush Securities told Benzinga she didn’t think the vaccine was “the culprit” in the failed trial. That’s because “the booster study demonstrated immunogenicity that suggests the vaccine is working in a manner consistent with what we have seen in phase 2 and in other populations,” she said, according to the publication.
Nonetheless, Gaithersburg, Maryland-based Novavax isn’t giving up. Last month, it announced a phase 2 study that’ll enroll up to 300 adults aged 60 or older, testing the shot in one or two doses with or without a proprietary Matrix-M adjuvant, and with or without an aluminum adjuvant.
It’s also testing the shot’s ability to protect infants through maternal immunization with help from an $89 million grant from the Bill & Melinda Gates Foundation.
Some competitors in the field include Sanofi, AstraZeneca’s MedImmune, Johnson & Johnson’s Janssen, GlaxoSmithKline and Bavarian Nordic, according to the global healthcare organization PATH.
Last month, BN CEO Paul Chaplin told FiercePharma his company has moved into a desirable position in RSV after it posted positive early data and after Novavax’s late-stage failure. Bavarian Nordic has a “differentiated approach and one that I think will be successful in the long run,” Chaplin said.
Also on Monday’s call, Novavax’s Erck told analysts and investors the company is pressing ahead with Zika and seasonal flu candidates based on its recombinant nanoparticle vaccine tech.