Press Release

Dynavax Announces Partnership with Albertsons Companies’ Pharmacies to Offer HEPLISAV-B® Hepatitis B Vaccine to Patients Nationwide

Dec 5, 2019 at 8:00 AM EST

- Partnership at 1,700 pharmacies nationwide with special focus on people living with diabetes
- People living with diabetes are two times more likely to become infected with hepatitis B virus and up to four times as likely to get HBV-related liver cancer

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EMERYVILLE, Calif., Dec. 05, 2019 (GLOBE NEWSWIRE) -- Dynavax Technologies Corporation (NASDAQ: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, and Albertsons Companies, one of the largest food and drug retailers in the United States, have partnered to provide HEPLISAV-B at Albertsons Companies’ more than 1,700 pharmacies nationwide, with a special focus on people living with diabetes. Through this partnership, patients will have access to HEPLISAV-B, the only FDA-approved two-dose hepatitis B vaccine for adults that is completed in one month. HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

“Immunizations are an important part of preventative care and are crucial to preventing the spread of serious illness, like hepatitis B,” said Brian Hille, Vice President, Patient, Specialty and Wellness Services, Albertsons Companies. “Because diabetic patients are two times more likely to become infected with the hepatitis B virus and up to four times as likely to get HBV-related liver cancer, it makes sense to increase access to the HEPLISAV-B vaccine for these patients at our pharmacies, which are low barrier, easy access health and wellness centers in our communities.”

Hepatitis B is a liver infection caused by the hepatitis B virus (HBV). It is estimated that 15 to 25 percent of patients with chronic hepatitis B develop chronic liver disease, including cirrhosis, liver failure, or liver cancer.i People living with diabetes are at increased risk for hepatitis B since the hepatitis B virus can be spread through everyday disease management activities such as sharing blood glucose meters, fingerstick devices or other diabetes-care equipment including syringes or insulin pens.ii The CDC recommends HBV vaccination for all adults with diabetes who are younger than 60 years old.iii

“We are committed to the prevention of hepatitis B by ensuring access to vaccines in all sites of care,” said Ryan Spencer, Co-President for Dynavax. "Community pharmacists play a major role in immunizing patients in their neighborhoods, and we are pleased that Albertsons Companies’ pharmacists will be able to help educate patients at risk for hepatitis B and conveniently provide vaccination with HEPLISAV-B.”

No appointment is necessary to receive the HEPLISAV-B vaccination at Albertsons Companies’ pharmacies during normal business hours. Hepatitis B vaccine and other vaccines, as permitted per state law, can be administered on a “walk-in” basis and are offered at more than 1,700 Albertsons Companies’ pharmacy locations, including those in Albertsons, Safeway, Vons, Jewel-Osco, Shaw's, Acme, Tom Thumb, Randalls, Pavilions, Star Market, Haggen, and Carrs stores. Private insurers, Medicare and Medicaid are required to cover preventative HBV testing and vaccines usually without a deductible or co-pay. Payer coverage for HEPLISAV-B has been established for 100% of Medicare lives, more than 95% of Commercial lives, and 90% of Medicaid fee-for-service lives.

Please see Important Safety Information below. 

For more information about HEPLISAV-B, visit http://heplisavb.com/.

About Hepatitis B
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,iv 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. The CDC recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.v 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.vi Approximately 20 million U.S. adults have diabetes, and 1.5 million new cases of diabetes are diagnosed each year.vii

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

Indication and Use 
HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

Important Safety Information (ISI)
Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast.

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B.

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B.

Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.
The most common patient reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%) and headache (8% to 17%).

For full Prescribing Information for HEPLISAV-B, click here.

About Dynavax
Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines. The Company launched its first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], in February 2018, following U.S. FDA approval for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.  For more information, visit www.dynavax.com and follow the company on LinkedIn.

About Albertsons Companies
Locally great and nationally strong, Albertsons Companies is one of the largest food and drug retailers in the United States. We operate stores across 34 states and the District of Columbia under 20 well-known banners including Albertsons, Safeway, Vons, Jewel-Osco, Shaw’s, Acme, Tom Thumb, Randalls, United Supermarkets, Pavilions, Star Market, Haggen and Carrs, as well as meal kit company Plated based in New York City. Albertsons Companies is committed to helping people across the country live better lives by making a meaningful difference, neighborhood by neighborhood. In 2018 alone, along with the Albertsons Companies Foundation, the company gave $262 million in food and financial support. These efforts helped millions of people in the areas of hunger relief, education, cancer research and treatment, programs for people with disabilities and veterans’ outreach.

Forward-Looking Statements 
This press release contains forward-looking statements, including statements regarding the commercialization of HEPLISAV-B. These statements are subject to a number of risks and uncertainties that could cause actual results to differ materially, including whether the company will be able to continue building the commercial infrastructure required to successfully launch HEPLISAV-B; and whether payers will provide timely reimbursement for HEPLISAV-B.  For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Dynavax in general, see risks detailed in the "Risk Factors" section of our most recent current periodic report filed with the SEC. These statements represent our estimates and assumptions only as of the date of this press release. We do not undertake any obligation to update publicly any such forward-looking statements, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in our current periodic reports with the SEC.

Media Contact
Elizabeth Fatone
Ph. (310) 963-5221
ElizabethFatone@SamBrown.com

Investor Contact
Nicole Arndt
Ph. (510) 665-7264
narndt@dynavax.com

US-19-02-0035

i CDC. https://www.cdc.gov/hepatitis/abc/index.htm

ii CDC. https://www.cdc.gov/diabetes/pubs/pdf/hepb_vaccination.pdf

iii CDC. https://www.cdc.gov/hepatitis/populations/diabetes.htm

iv CDC. https://www.cdc.gov/hepatitis/hbv/bfaq.htm

v CDC. https://www.cdc.gov/hepatitis/hbv/hbvfaq.htm

vi CDC. https://www.cdc.gov/diabetes/pubs/pdf/hepb_vaccination.pdf

vii CDC. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf

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Source: Dynavax Technologies Corporation