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FDA clears Dynavax’s HBV vaccine Heplisav-B, launch slated for first quarter of next year

By Randy Osborne, Staff Writer

Dynavax Technologies Corp. said it will launch Heplisav-B hepatitis B virus (HBV) vaccine in the first quarter of next year, the FDA having approved the compound late yesterday for preventing infection caused by all known subtypes of HBV in patients ages 18 and older.

Shares of the Berkeley, Calif.-based firm (NASDAQ:DVAX) were trading at $22.70, up $2.65, or 13 percent, in pre-market trading.

The approval was based on data from three phase III noninferiority trials in almost 10,000 adult participants who received the vaccine. Studies compared Heplisav-B administered in two doses over one month to HBV vaccine Engerix-B from Glaxosmithkline plc (GSK), of London, administered in three doses over a six-month schedule. In results from the largest experiment, which included 6,665 participants, Heplisav-B turned up a statistically significantly higher rate of protection of 95 percent compared with 81 percent for Engerix-B.

Clinical news was good, too, in a Heplisav-B subgroup analysis of 961 participants with type 2 diabetes, where the vaccine showed a statistically significantly higher rate of protection of 90 percent compared to 65 percent for the GSK product. Across the three trials, the most common local reaction was injection-site pain (ranging from 23 percent to 39 percent). The most common systemic reactions were fatigue (11 percent to 17 percent) and headache (8 percent to 17 percent).

In July, members of the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) debated an apparent cardiovascular (CV) signal that had garnered Dynavax its second complete response letter for Heplisav-B. VRBPAC panelists ultimately voted 12-1 with three abstentions that the available data prove the vaccine safe enough for approval, although they said the CV factor should be explored more fully in a postmarketing study. (See BioWorld, July 31, 2017.)

Cowen and Co. analyst Phil Nadeau said the Heplisav-B label “appears favorable, as it includes results from secondary efficacy endpoints vs. Engerix-B, data on patients with diabetes, and a relatively benign treatment of the adverse-event data. We continue to think that Dynavax is undervalued for Heplisav,” he added in a research report.

Dynavax has not disclosed pricing for Heplisav-B, of which, Nadeau noted, the firm “has a stock of 250,000 vaccines ready for packaging and distribution, and enough raw material to manufacture an additional 750,000 doses.” The company will make more Heplisav-B starting in the second half of next year, and at launch will “disperse its sales force to cover more than 75 percent of targeted institutions,” he wrote.