Dynavax is touting Phase III data announced this week showing that its hepatitis B vaccine Heplisav-B bested the standard-of-care Engerix-B, marketed by GlaxoSmithKline ($GSK) and first approved in 1989.
Berkeley, CA-based Dynavax said its candidate demonstrated statistically significant higher seroprotection rates of 95% compared to 81% for the Engerix-B group. For the trial, dubbed HBV-23, investigators divided participants into an 18-to-39 age range, finding that 99% of people in that group who received Heplisav-B were seroprotected versus 93% in the Engerix-B arm. The other group, ages 40 to 70, showed seroprotection rates of 95% for Heplisav-B compared to 79% for Engerix-B.
Dynavax’s vaccine is administered in two doses one month apart versus Engerix-B’s regimen of three doses over 6 months, a fact that RBC Capital Market’s Simos Simeonidis has previously said could help the shot get a majority of a $270 million market upon approval.
Bell’s palsy occurred in 0.09% of the Heplisav-B participants in the HBV-23 trial versus a rate of 0.04% in the Engerix-B group. Investigators noted single cases each of alopecia areata, polymyalgia rheumatic and ulcerative colitis in the Heplisav-B arms, as well. The data bring the vaccine’s safety database to 14,238 participants, more than 10,000 of whom have received Heplisav-B.
The PDUFA date for Heplisav-B is Sept. 15, 2016.
- here’s the release