Dynavax building out infrastructure for a Heplisav-B launch, CEO says

SAN FRANCISCO—Dynavax fought hard to win FDA approval for its twice-rejected hepatitis B vaccine, but now that it has a marketing license for Heplisav-B, the small biotech's work is only just starting. While the company doesn't expect an immediate deluge of sales, it's been busy staffing up and setting up its commercial infrastructure to support the rollout. 

The vaccine launched this week at the wholesale acquisition price of $115 per dose, or $230 per regimen. On the market, Dynavax will challenge vaccines giant GlaxoSmithKline and its Engerix-B, a decades-old vaccine that runs $22.40 per dose, according to the CDC. Engerix-B is a three-dose regimen that was first approved in 1989. 

Speaking with FiercePharma on the sidelines of the J.P. Morgan Healthcare Conference, Dynavax CEO Eddie Gray said there are a couple reasons the company is charging a premium. One, he said, is that payers believe his company's product profile is superior. Another is the two-dose advantage. 

"We have used standard measures of costs in the system to work back to ensuring that for every successful vaccination they get, that they are paying a similar price to what they pay now," he said. "What we offer them is that a lot more people will be successfully vaccinated." 

Dynavax is gearing up for the launch by hiring a commercial sales team of about 60 people, Gray said. The team should be in place by the middle of next month when the CDC's Advisory Committee on Immunization Practices meets and potentially recommends the vaccine. Shortly after, Gray said, Dynavax should be able to ink agreements with payers for reimbursement. 

The biotech doesn't expect an immediate wave of sales, Gray said, so the first six months of 2018 are all about getting ready. Plus, he said, customers have stocks of Engerix-B on hand that they will want to use before potentially switching.

"We'll see [the launch] start to ramp in the second half of this year with big inflections in 2019 and 2020," Gray said. Eventually, he believes Dynavax can capture a "very high" market share, but he declined to put out a concrete number. 

And while the CEO believes Dynavax can handle a U.S. marketing operation, launches around the world would be more of a challenge. He said the biotech will explore partnerships for those.  

Dynavax won Heplisav-B approval in November for prevention of infection from all known hepatitis B subtypes in people ages 18 and older. Before that, the FDA rejected the vaccine in 2013 and 2016 and requested more safety data and more details about postmarketing plans.

Also eyeing the field is VBI Vaccines, which recently started a phase 3 program comparing its candidate with GSK's shot. GSK's Engerix-B was among a group of hepatitis shots that generated £602 million ($810 million) last year.