With ACIP recommendation, is tiny Dynavax set to win the hepatitis B sweepstakes with Heplisav-B?

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California-based Dynavax reported quarterly revenue of $108 million on Thursday, with hepatitis B vaccine Heplisav-B accounting for $22.7 million, its most in a quarter since its launch in 2017. (Fierce Pharma)

A CDC advisory committee on Wednesday strengthened its recommendations for hepatitis B vaccination, and that's likely to flood the market with people seeking shots. Among the three approved vaccines, Dynavax’s Heplisav-B is poised to take the most advantage, said analysts at Evercore ISI.

“Heplisav-B already is positioned to be the standard of care, given its greater efficacy and two-dose schedule,” Evercore wrote in a note to investors.

While Dynavax's two doses are given a month apart, the other vaccines on the market, GlaxoSmithKline’s Engerix-B and Merck’s Recombivax HB, are generally administered in three doses over a six-month span.

Evercore believes the CDC's latest recommendation will expand the hepatitis B market by 50% to $600 million, “significantly accelerating Heplisav-B sales in the coming quarters.” During Dynavax’s third-quarter earnings presentation on Thursday, the California-based company estimated the hepatitis B vaccine market at $800 million.

Sales for Heplisav-B came in at $22.7 million, the most in a quarter since its launch in 2018 and accounting for more than one-fifth of the 25-year-old company’s revenue of $108.3 million for the period.

While CDC's prior guidance noted that all adults "may" get a vaccine, its recommendation for those who "should" receive it was focused only on adults deemed at a high risk. With this week's 15-0 CDC panel vote, all those between 19 and 59 years, regardless of risk factors, are now included in the category of those who should get the vaccine. Those who are 60 years and older who are at risk should also get the vaccine, the panelists said. Other adults who want to get vaccinated remain eligible as well.  

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After failed attempts to gain approval in 2013 and 2016, Heplisav-B finally prevailed in November 2017, setting it up to take on Engerix, the dominant shot for hepatitis B since it was approved in 1989. 

“Heplisav-B provides an important foundation for our company as our lead commercial asset, generating durable, long-term revenue growth,” Dynavax CEO Ryan Spencer said in a conference call.

Most U.S. residents 30 and younger have been vaccinated for hepatitis B, as it was established in 1991 as standard practice. In 2005, it was recommended that newborns be vaccinated for hepatitis B before discharge from the hospital.

Engerix and Recombivax have adult and pediatric formulations, while Heplisav is designed solely for people 18 and older.

Wednesday’s recommendation from the Advisory Committee on Immunization Practices is subject to final approval by CDC director Rochelle Walensky.

The CDC recommendation defines those with risk factors as incarcerated people, those at high risk for infection, people who travel to places with endemic HBV, those who have chronic liver disease and people who have HIV.

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It is estimated that 2 million people living in the U.S. have chronic hepatitis B and have a 15% to 25% risk of premature death from cirrhosis or liver cancer. There are approximately 20,000 new cases every year, and the rate has stopped declining.

“The past decade has illustrated that risk-based screening among adults has got us as far as it can take us,” Mark Weng, M.D., who leads the ACIP working group, said. “We’re losing ground. We cannot eliminate hepatitis B in the U.S. without a new approach.”

The virus is spread through the exchange of bodily fluids like blood and semen. Many cases have been linked to the opioid epidemic.

The Hepatitis B Foundation applauded the ACIP's recommendation.

“It has been frustrating to watch rates of infection rise when we know that there is a safe and effective vaccine that can prevent hepatitis B and liver cancer," said the foundation's Michaela Jackson in a statement. "This recommendation will help remedy a very significant health inequity for marginalized groups and it will serve to make many adults in the U.S. safer.”