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Dynavax caps a long-running regulatory saga with an FDA OK for hep B vaccine Heplisav

Regulators have been fretting for the last 5 years about Dynavax’s Heplisav, a hepatitis B vaccine linked to a long-running string of unexplained safety issues, including an imbalance in the rate of cardio events that suggested an underlying issue no one could clearly define. But Thursday night came formal word that Dynavax’s long regulatory odyssey in search of an approval — after two earlier rejections — was over. The FDA sanctioned the vaccine for a commercial launch.

Eddie Gray, Dynavax CEO

The FDA never has completely let go of its safety concerns, producing a label that provides the clinical data Dynavax $DVAX had gathered along the way. But the data also includes an efficacy profile that’s clearly superior to GSK’s Engerix-B. And now the biotech — which has failed to produce a partner for this product after promising last year to give it a try — will go up against the pharma giant with a sales force of about 50 in the US.

RBC’s Matthew Eckler looked it all over and gave Dynavax a thumbs up in the David-vs-Goliath struggle to come:

Given Heplisav’s superior efficacy and convenience profile, we continue to see potential to grow the current hep B vaccine market (~$270M) through increased compliance, premium pricing, and the capture of adult diabetic population, resulting in $300M projected peak revenue.

Dynavax shares surged 15% on the news, though it wasn’t unexpected after a panel vote in its favor.

The biotech’s vaccine — a combo of a hepatitis B surface antigen and a TLR9 agonist — provided a protection rate of 95% compared with 81% for Engerix-B. In a subgroup analysis of Type 2 diabetes patients, the range was 90% to 65%.

The vaccine industry is a big field dominated by global players like Sanofi and GlaxoSmithKline. That’s one reason why the biotech has been the subject of considerable speculation that it was a potential buyout target, including a recent piece from Reuters claiming that some potential buyers had been in to kick the tires. Nothing has come of that, so far. And Dynavax CEO Eddie Gray has insisted that the plan all along has been to commercialize the vaccine, with help from a partner.


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