Dynavax Announces FDA Advisory Committee Meeting to Review HEPLISAV-B

BERKELEY, CA--(Marketwired - April 03, 2017) - Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that the U.S. Food and Drug Administration (FDA) has informed the company that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will review HEPLISAV-B™ [Hepatitis B Vaccine, Recombinant (Adjuvanted)] at its meeting scheduled for July 28, 2017. The scheduled VRBPAC meeting is close to the HEPLISAV-B Prescription Drug User Fee Act (PDUFA) date of August 10, 2017 solely as a function of meeting logistics. The PDUFA date remains unchanged. The FDA will communicate specific questions for the VRBPAC to address closer to the meeting date, and will post a draft agenda and draft questions on its website 48 hours prior to the meeting. HEPLISAV-B is the company's vaccine candidate for immunization against hepatitis B infection in adults ages 18 years of age and older.

"The notification of a VRBPAC meeting comes as no surprise and thus we are prepared for it," said Eddie Gray, chief executive officer of Dynavax. "The company looks forward to continuing to work with the FDA through the review process and discussing HEPLISAV-B with the advisory committee."

The VRBPAC reviews and evaluates data regarding the safety and efficacy of vaccines and related biological products that are intended for use in the prevention, treatment, or diagnosis of human diseases.

About Hepatitis B
Hepatitis B is a viral disease of the liver that can become chronic and can lead to cirrhosis of the liver, hepatocellular carcinoma and death. In the United States, the Centers for Disease Control and Prevention estimates that 19,000 hepatitis B infections continue to occur annually, with the vast majority occurring in adults. There is no cure for hepatitis B, and disease prevention through more effective vaccines is critical to reducing the spread of the disease.

About HEPLISAV-B
HEPLISAV-B is an investigational adult hepatitis B vaccine that combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response. In Phase 3 trials, HEPLISAV-B showed higher and earlier protection with fewer doses than a currently licensed hepatitis B vaccine. The most frequently reported local reaction was injection site pain. The most common systemic reactions were fatigue, headache and malaise, all of which were similar to an existing vaccine.