European CHMP Adopts Positive Opinion for HEPLISAV-B

Dynavax Technologies announced the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the company's Marketing Authorization Application, recommending the granting of marketing authorization for HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted] for the active immunization against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. The CHMP recommendation was based on the assessment of HEPLISAV-B demonstrated by the safety and immunogenicity results from three Phase 3 clinical trials and post-marketing safety results.

"Hepatitis B is a highly infectious and potentially deadly virus with increasing infection rates, and over 250 million people infected worldwide. Thankfully, it can be prevented with effective vaccination," commented Ryan Spencer, Chief Executive Officer of Dynavax. "With a regimen of only two doses in just one-month, HEPLISAV-B provides a unique opportunity to address known challenges with patient compliance, while delivering faster and higher rates of seroprotection compared to the three dose regimen over 6 months for the comparator vaccine. The positive CHMP opinion is an important step to extending the benefits of HEPLISAV-B beyond the United States, where it was approved in 2017."

In the European Union (EU), HEPLISAV-B is not yet approved. Under the EU regulatory process, the European Commission will now review the CHMP recommendation and the final decision on Marketing Authorization is expected in the first quarter of 2021. If approved by the European Commission, Dynavax would receive marketing authorization for HEPLISAV-B in all EU Member States.

Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV, and transmission is on the rise. There is no cure for hepatitis B, but effective vaccination can prevent the disease. In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person.

HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax's proprietary Toll-like Receptor (TLR) 9 agonist CpG 1018 to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.