- Novavax Inc. plans on beginning approval applications for its lead candidate after positive late-stage data reinforced both the biotech's and investors' confidence.
- A primary completion date for the Phase 3 study of Novavax's vaccine for respiratory syncytial virus (RSV) is still years away, but an informational analysis found that, after 90 days, the vaccine met an efficacy threshold of greater than 40% against the study's primary endpoint. A data safety monitoring board statistician conducted the unblinded analysis.
- Novavax's vaccine has failed in the clinic before, and the latest findings don't guarantee that it will succeed this time around. But the pipeline update did appear to renew shareholder's optimism in the Maryland-based biotech, which saw its shares spike 57% on Wednesday but then open 8% down Thursday.
The Centers for Disease Control and Prevention estimates that more than 230,000 people in the U.S. are hospitalized each year due to RSV, most of which are elderly adults and children under five years of age.
There aren't any approved vaccines for RSV. A handful of drugmakers have made efforts, but not without setbacks. Regeneron Pharmaceuticals Inc. dumped its drug suptavumab in August after it failed to significantly prevent medically-attended RSV infections in infants.
Novavax too saw its RSV candidate miss the mark in a Phase 3 trial that tested the drug in older adults. The biotech's stock subsequently lost 80% of its value.
In spite of the failure, Novavax said it would continue with another late-stage study to determine benefit in giving pregnant women the vaccine to prevent newborns from developing symptomatic RSV lower respiratory tract infections (LRTI) with hypoxemia.
While the informational analysis of that trial presents a rosier outlook for Novavax's vaccine, it's important to note the results mainly show the drug isn't failing so far. A more comprehensive interim analysis is expected in mid-2018. If everything goes without a hitch, the biotech anticipates filing its vaccine with the FDA in late 2019.
"Novavax wanted to ensure that the ongoing investment in the program was justified based on a high probability of a commercially-viable determination of efficacy," the company wrote in a presentation at the J.P. Morgan Healthcare Conference earlier this week.
Novavax is funding the RSV program with the help of $89 million from the Bill and Melinda Gates Foundation. As of Sept. 30, the company had spent $119 million on R&D, most of which stemmed from activities related to its RSV vaccine.
Should the program gain approval, Novavax expects it would offer a "multi-billion dollar revenue opportunity," according to an August filing with the Securities and Exchange Commission.