Dynavax Receives European Approval For Manufacturing Heplisav Hepatitis B Surface Antigen

Dynavax’s GMP manufacturing facility in Dusseldorf, Germany has been approved for the commercial production of hepatitis B surface antigen, a key component of Heplisav, an investigational adult hepatitis B vaccine. The approval comes as a result of an upgrade expanding production capacity.

With an updated EU GMP manufacturing license in place, Dynavax can meet the initial commercial production demands for the anticipated launch of Heplisav.

Dynavax’s German subsidiary, Rhein Biotech has manufactured the hepatitis B surface antigen for Heplisav clinical trials in this facility since 2006. The facility upgrade also enhances integrated product development and manufacturing services Rhein Biotech provides to third party partners.

Heplisav is an investigational adult hepatitis B vaccine. In a completed pivotal Phase 3 trial, Heplisav demonstrated increased, rapid protection with fewer doses than current licensed vaccines.

Dynavax has worldwide commercial rights to Heplisav and is developing the vaccine for large, high-value populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease. Heplisav combines hepatitis B surface antigen with a proprietary toll-like receptor 9 agonist known as ISS to enhance the immune response.