HepB vax Heplisav posts positive Ph3 data

Dynavax ($DVAX), which is based in Berkeley, CA, released a new round of Phase III data on its hepatitis B vaccine, Heplisav. The data focused on specific hypo-responsive groups--males, smokers and obese patients--using two doses of Heplisav compared to three doses of GlaxoSmithKline's ($GSK) Engerix-B. In all test groups, Heplisav was superior or non-inferior to the competing vaccine.

"It has long been known that males, the obese, and smokers have an impaired response to current licensed HBV vaccines," said Dr. Tyler Martin, president and chief medical officer for Dynavax. "Not only was Hepsilav superior to Engerix-B in each of these subpopulations, the seroprotection rates in the Hepsilav group did not decline for any hypo-responsive subset, in comparison to the responsive subset. These results substantially strengthen the observation that Hepsilav is superior to Engerix-B."

Back in July, study results showed product inconsistencies that worried investors.

- see the Dynavax release
- here's the AP report
- and the article from San Francisco Business Times
- read more from Pharmaceutical Business Review

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