Dynavax finally pushes hep B vaccine over the finish line
- Dynavax Technologies Corp. announced after market close on Thursday the Food and Drug Administration has approved its hepatitis B vaccine Heplisav B for the prevention of the liver disease in adults 18 years and older.
- Originally submitted for approval in April 2012, Dynavax has had a long winding road to get this vaccine on the market, overcoming two rejections, two advisory committee meetings and multiple regulatory delays from the FDA asking for more information.
- Dynavax plans to commercialize the drug with a small salesforce of 55 people. CEO Eddie Gray noted in an interview that big pharma companies typically detail a drug like this with only 50 to 70 sales reps.
Earlier this year, Dynavax announced this would be the company's last attempt to try to secure approval for the hepatitis B vaccine. Despite that, Gray's confidence in the product never wavered. The CEO told BioPharma Dive in an interview that the regulatory setbacks had "primarily been a challenge of process rather than content," pointing to two positive advisory committee meetings.
Although he admitted "the process was a lot more tortuous than it needed to be."
Heplisav B faced the FDA's panel of advisors twice — once in 2012 and again in 2017. The first affirmed the experts' confidence in the product's efficacy, voting 13 to 1 to recommend approval for the product. The second affirmed their confidence in its safety, voting 12 to 1 in favor of the drug.
Despite those reassurances, Dynavax received a Complete Response Letter in 2013 and then another in 2016. And there have been a number of other regulatory delays as well. The FDA, for example, pushed back the user fee action date by three months from August to November of this year when it needed further clarification once again.
Now that Heplisav B has finally made it to market, Gray assures it will be a "commercial success." Currently, there are two main competing vaccines on the market —GlaxoSmithKline plc's Engerix-B and Merck & Co.'s Recombivax HB. Both company's reported shortages of their respective products earlier this year and Merck has said it will not sell the vaccine in the U.S. again before the end of 2018.
Beyond that, both drugs are given in three doses over a six month period. Gray points out that many patients never come back for that third shot. But Heplisav B has an advantage here, it's given in only two doses one month apart, making compliance more likely.
Gray also said adult vaccines are typically easier to commercialize with a small sales staff — the people who are required to get the vaccine include doctors, nurses, or other healthcare professionals, as well as travelers and people who need dialysis. He called it an ideal market because of its "contained environment."
Heplisav B will launch in the first quarter of 2018. Dynavax expects a slow launch as it deals with access challenges and it "re-energizes" its manufacturing throughout the year.
The company has yet to set a price for the drug, but said in an emailed statement that its "pricing and access strategy will be aimed at ensuring that populations at risk of infection are able to access this new vaccine, while recognizing the value it brings to the healthcare system with a two dose regimen and higher rates of protection compared to Engerix-B."
- Dynavax Technologies Corp. Press release
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