VBI Vaccines execs tout approval of new triple-antigen hepatitis B shot. Can they sell it?
VBI Vaccines celebrated a new approval Wednesday morning, announcing the FDA has greenlighted its hepatitis B vaccine for adults. But questions remain on how well the new shot will sell.
The biotech intends to hit the market in the first quarter of next year, joining three other adult hepatitis B vaccines from Merck, Dynavax and GlaxoSmithKline. CEO Jeff Baxter said in an analyst call Wednesday the price of VBI’s shot, branded as PreHevbrio, won’t be revealed until commercialization, but claimed it would be “highly competitive.”
In response to the news, VBI shares $VBIV traded about 15% higher in Wednesday’s pre-market session. The price remains well within penny stock territory, hitting about $3.45 per share.
Merck and Dynavax are the big names in this market, and Baxter faced questions from investors on Wednesday’s call about how VBI intends to differentiate itself from those two shots. Baxter touted VBI’s vaccine as the first to contain three different antigens against the hepatitis B virus and said that the “90 percent-plus” protection after two doses gives VBI a potential advantage.
One key remaining piece is a full sign-off from the CDC’s ACIP, which voted last month to broadly recommend universal hepatitis B vaccines to all adults aged 19-59. Baxter noted the endorsement for VBI’s shot would need to happen before launch, but demurred when asked if he wanted to see additional updates to the vaccine recommendations.
“At this stage I don’t think it goes beyond that but just given that recommendation obviously … it is a very important first step, and creates a level playing field for PreHevbrio,” Baxter said on the call.
He added that the full go-ahead will help VBI get its shot covered by both public and private and insurers, giving it another avenue to cut into the Merck and Dynavax pie. But the biotech will also need to engage in awareness campaigns with physicians as well, for which Baxter said VBI is prepared.
Approval of the new vaccine came due to two Phase III studies, published in scientific journals in May and October of this year. VBI compared its vaccine to GSK’s shot, which only includes one of the hepatitis B antigens. The first study showed higher seroprotection in all adults, at 91.4% to 76.5%, as well as adults over 45 — 89.4% to 73.1%.
The second study, meanwhile, aimed to show that VBI’s seroprotection remained consistent across three different vaccine lots. After two doses, PreHevbrio managed a 90.4% seroprotection rate compared to 51.6% for the control. The rates increased for both vaccines after third doses, hitting 99.3% and 94.8%, respectively.
Outside the US, the EMA is continuing its review of the shot, while VBI is planning to file regulatory submissions to the UK and Canada early next year.