Dynavax Announces HEPLISAV-B Post-Marketing Requirement Interim Report Completed
December 03 2019 - 7:00AM
Dynavax Technologies Corporation (NASDAQ: DVAX), a
biopharmaceutical company focused on developing and commercializing
novel vaccines, today announced that it has filed a report on a
cumulative analysis (comprising both required interim analyses)
of its post-marketing study of HEPLISAV-B® [Hepatitis B
Vaccine (Recombinant), Adjuvanted] for review by the U.S. Food and
Drug Administration (FDA). The study is assessing the rates of
occurrence of acute myocardial infarction (AMI) in persons
receiving HEPLISAV-B compared with Engerix-B. The interim
report assesses unadjudicated events of AMI. The event rates in
this interim analysis were similar between the two treatment arms.
The independent data monitoring committee (DMC) concurred this
analysis showed no evidence of an increase in AMI events in the
HEPLISAV-B arm. The study was initiated in August 2018 and
will continue through November 2020. Final study results will
be reported upon study completion.
“These results reinforce our previous clinical
data regarding the safety of HEPLISAV-B and support our confidence
that HEPLISAV-B can be the emerging standard of care for preventing
hepatitis B infection in adults,” commented Robert Janssen, MD,
Chief Medical Officer. “We are pleased to collaborate with
Kaiser Permanente Southern California for their rigorous
conduct of this study, and look forward to a scientific
presentation of the final data at an appropriate forum in the
future.”
The study, “Post-Marketing Observational Study
to Evaluate the Occurrence of Acute Myocardial Infarction in Adults
18 Years of Age and Older Who Receive HEPLISAV-B Compared with
Another Hepatitis B Vaccine,” is a post-marketing requirement
related to FDA approval of HEPLISAV-B on November 9, 2017.
Dynavax previously announced the complete accrual of more than
30,000 patients who received HEPLISAV-B and more than 30,000
patients who received Engerix-B in the ongoing post-marketing
study.
About Hepatitis BHepatitis 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,i 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.ii Because people with diabetes are
particularly vulnerable to infection, the CDC recommends
vaccination for adults age 19 to 59 years with diabetes as soon as
possible after their diagnosis, and for people age 60 years 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
About HEPLISAV-BHEPLISAV-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.
For more information about HEPLISAV-B, visit
http://heplisavb.com/.
About DynavaxDynavax 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.
Forward-Looking Statements Statements contained
in this press release regarding matters that are not historical
facts are "forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995, including
statements regarding the ongoing observational comparative study,
the expected completion of the study, and the potential for
HEPLISAV-B to be the leading hepatitis B vaccine or become the
emerging standard of care in preventing hepatitis B infection in
adults. These forward-looking statements are based upon
management’s current expectations, are subject to known and unknown
risks, and involve assumptions that may never materialize or may
prove to be incorrect. Actual results and the timing of
events may differ materially from those anticipated in such
forward-looking statements due to various risks and uncertainties
inherent in our business, including, without limitation, the risk
that the study may not be completed when expected, or at all; the
risk that final study results may not be consistent with the
interim analyses or may differ from them in a material way; the
risk that prescribers and other key decision-makers at potential
purchasing entities may not make the decision to switch to
HEPLISAV-B; and the timing and quantity of actual purchases; risks
related to market adoption and competing therapies; and risks
related to whether payors will cover and provide timely and
adequate reimbursement for HEPLISAV-B. These and other risks
are described in the "Risk Factors" section of our Quarterly Report
on Form 10-Q for the quarter ended September 30, 2019, as well as
discussions of potential risks, uncertainties and other important
factors in our other filings with the U.S. Securities and Exchange
Commission. We undertake no obligation to revise or update
information herein to reflect events or circumstances in the
future, even if new information becomes available.
Contacts:Nicole Arndt, Senior Manager, Investor
Relationsnarndt@dynavax.com510-665-7264
Derek Cole, President Investor Relations Advisory Solutions
derek.cole@IRadvisory.com
i CDC. https://www.cdc.gov/hepatitis/hbv/bfaq.htm.ii CDC.
https://www.cdc.gov/hepatitis/hbv/hbvfaq.htm.iii CDC.
https://www.cdc.gov/diabetes/pubs/pdf/hepb_vaccination.pdf.iv CDC.
https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf.
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