Set on challenging GlaxoSmithKline's hepatitis B shot, Dynavax gears up for Heplisav launch

Dynavax is underway with launch plans as it awaits FDA approval on Heplisav-B, according to an analyst note.

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. 

Dynavax plans to support its Heplisav-B launch with three managers, nine regional directors and 35 account managers, RBC Capital Markets analysts wrote in a note after meeting with the company's leadership last week. Fortunately for Dynavax, it'll be operating in a "highly concentrated" market that's "well suited for a small biotech," the analysts wrote. Management told the analysts they hope to grow the U.S. adult hep B market to $500 million in annual sales, from the current level of $270 million. 

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." 

FDA officials are set to act on the vaccine later this year after already turning it down on two occasions in 2013 and 2016. This time around, an FDA expert panel endorsed the vaccine back in July; the agency extended its review last month to learn more about Dynavax's postmarketing plan. Executives at the time said there wasn't a cause for alarm and are still confident they'll win approval before the FDA's action date, according to the note from RBC Capital Markets. 

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.