Benzinga | May 27, 2021 07:05AM EDT

Dynavax Announces Agreement With Bavarian Nordic For Commercialization Of HEPLISAV B; Financial Terms Not Disclosed

Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced it has entered into a commercialization agreement with Bavarian Nordic for the marketing and distribution of HEPLISAV B [Hepatitis B Vaccine (Recombinant), Adjuvanted] in Germany with an expected launch in the fourth quarter of 2021.

In February 2021, the European Commission (EC) granted marketing authorization for HEPLISAV B 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. HEPLISAV B is the only U.S. Food and Drug Administration (FDA) and EC approved hepatitis B vaccine for adults with a two-dose regimen that is completed in one month.

Hepatitis B is a highly infectious and potentially deadly virus with increasing infection rates, and over 250 million people infected worldwide. Hepatitis B can be prevented with effective vaccination. HEPLISAV B, with a two-dose regimen that takes only one month to complete and a statistically significantly higher seroprotection rate in head-to-head clinical trials, provides a unique opportunity to address known challenges with compliance, while delivering higher levels of protection compared to the three-dose regimen of the comparator vaccine.

Ryan Spencer, Chief Executive Officer of Dynavax, commented: "We are excited to work with Bavarian Nordic on the commercialization of HEPLISAV B in Germany. Their existing marketing and distribution network in Germany provides an excellent platform to make HEPLISAV B available to patients. The strong overlap with the existing target audience within general practitioners, occupational health groups and travel medicine specialists provides a good strategic fit and clear commercial synergies for the dedicated sales force Bavarian Nordic has established in Germany."

Paul Chaplin, President and CEO of Bavarian Nordic, commented: "We are pleased to expand our commercial footprint in the largest EU market by adding a complementary product to our marketing and distribution and we look forward to assisting Dynavax in a successful market entry in Europe later this year."