Dynavax Announces Agreement with Bavarian Nordic for Commercialization of HEPLISAV B®, a Two Dose Adult Hepatitis B Adjuvanted Vaccine, in Germany
EMERYVILLE, Calif., May 27, 2021 /PRNewswire/ -- Dynavax Technologies (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced it has entered into a commercialization agreement with Bavarian Nordic A/S 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."
About Hepatitis B
In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The U.S. Centers for Disease Control (CDC) recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.ii Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 with diabetes as soon as possible after their diagnosis, and for people age 60 and older with diabetes at their physician's discretion.iii Approximately 20 million U.S. adults have diabetes, and 1.5 million new cases of diabetes are diagnosed each year.iv
Important EU/EEA Product Information
The use of HEPLISAV B should be in accordance with official recommendations.
It can be expected that hepatitis D will also be prevented by immunisation with HEPLISAV B as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
For full E.U. Prescribing Information for HEPLISAV-B, click here.
Important EU/EEA Safety information
Appropriate medical treatment and supervision should be readily available in case of rare anaphylactic reactions following the administration of the vaccine.
The administration of HEPLISAV B should be postponed in subjects suffering from acute severe febrile illness.
Immunocompromised persons may have a diminished immune response to HEPLISAV B.
Because of the long incubation period of hepatitis B, it is possible for unrecognised HBV infection to be present at the time of immunisation. HEPLISAV B may not prevent HBV infection in such cases.
There are very limited data on the immune response to HEPLISAV B in individuals who did not mount a protective immune response to another hepatitis B vaccine.
As a precautionary measure, it is preferable to avoid the use of HEPLISAV B during pregnancy. Vaccination during pregnancy should only be performed if the risk-benefit ratio at the individual level outweighs possible risks for the fetus.
The most common patient-reported side effects reported within 7 days of vaccination were pain, swelling or redness at the injection site, feeling tired, headache, muscle aches, feeling unwell and fever.
Important U.S. Product Information
For full U.S. Prescribing Information for HEPLISAV-B, click here.
Important U.S. Safety Information (ISI)
About Bavarian Nordic
Derek Cole, President
i CDC. https://www.cdc.gov/hepatitis/hbv/bfaq.htm.
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SOURCE Dynavax Technologies
Company Codes: NASDAQ-SMALL:DVAX