Dynavax (NASDAQ:DVAX) Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing innovative vaccines, today announced that the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) has granted Marketing Authorization in Great Britain 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 approval was based on the positive benefit-risk for HEPLISAV B as demonstrated by the safety and immunogenicity results of three Phase 3 clinical trials. The approval was issued to Dynavax's affiliate Dynavax GmbH via the European Commission Decision Reliance Procedure (ECDRP).
"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. "We are very pleased that HEPLISAV B has received this latest approval and look forward to continuing on-going discussions with potential commercial partners for Great Britain. This approval highlights the capabilities and continued successful execution of the organization."
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