Eyeing vaccines giant GlaxoSmithKline and its standard-of-care hepatitis B shot, Dynavax is gearing up to launch a competitor early next year. As things stand, it’ll be assuming the daunting task of having its small internal team challenge a Big Pharma.
To get there, the biotech will count on “premium pricing, increased compliance, and penetration into adult diabetic patients,” the analysts wrote after the discussion.
Following an FDA panel’s recommendation this summer, RBC Capital Markets figures it’s a “matter of when, not if” that the company’s hep B vaccine candidate wins U.S. approval. The candidate has a Nov. 9 action date at the FDA.
Back in July, RBC projected that Dynavax could reach peak U.S. sales of $290 million in 2026. They wrote that the company is “open to monetizing/partnering deals but is also prepared to launch Heplisav on its own.”
First approved in 1989, GSK’s Engerix-B was among a group of hepatitis shots that generated £602 million ($810 million) last year for the pharma company. Aside from Dynavax, VBI Vaccines is also working on a potential challenger.