Dynavax Announces European Medicines Agency Accepts Marketing Authorization Application for HEPLISAV-B® for Prevention of He...
March 28 2019 - 4:05PM
Dynavax Technologies Corporation (NASDAQ:DVAX), a fully-integrated
biopharmaceutical company focused on discovering and developing
novel vaccines and immuno-oncology therapeutics, today announced
that the European Medicines Agency (EMA) has accepted the Company's
Marketing Authorization Application (MAA) for review of HEPLISAV-B
[Hepatitis B Vaccine, Recombinant (Adjuvanted)] for prevention of
infection caused by all known subtypes of hepatitis B virus in
adults age 18 years and older.
This acceptance follows Dynavax's submission of the
MAA on March 11 and marks the beginning of the regulatory review
process for HEPLISAV-B in the European Union (EU). The outcome of
the MAA review by the EMA is expected next year.
"The acceptance of the HEPLISAV-B application for
review by the EMA signifies an important milestone in our journey
to help prevent hepatitis B in adults through vaccination," said
Robert Janssen, M.D., chief medical officer of Dynavax. "Many
at-risk adults remain unprotected against this highly infectious
virus. HEPLISAV-B has been shown to provide higher rates of
protection with fewer doses than currently available vaccines. We
hope to make HEPLISAV-B available beyond the U.S. to help address
the global hepatitis B public health problem."
In 2017, the U.S. Food and Drug Administration
(FDA) approved HEPLISAV-B for prevention of infection caused by all
known subtypes of hepatitis B virus in adults age 18 years and
older. HEPLISAV-B was the first new hepatitis B vaccine in the U.S.
in more than 25 years and the only two-dose hepatitis B vaccine for
adults.
The MAA for HEPLISAV-B is based upon the successful
outcomes from three Phase 3 non-inferiority trials of nearly 10,000
adult participants who received HEPLISAV-B. The pivotal studies
compared HEPLISAV-B administered in two doses over one month to
Engerix-B administered in three doses over a six-month schedule.
Results from the largest Phase 3 trial, which included 6,665
participants, showed that HEPLISAV-B demonstrated a statistically
significantly higher rate of protection of 95% compared with 81%
for Engerix-B. Across the three clinical trials, the most common
local reaction was injection site pain (23% to 39%). The most
common systemic reactions were fatigue (11% to 17%) and headache
(8% to 17%).
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,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
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
fully-integrated biopharmaceutical company focused on leveraging
the power of the body's innate and adaptive immune responses
through toll-like receptor (TLR)
stimulation. Dynavax discovers and develops novel
vaccines and immuno-oncology therapeutics. The Company’s first
commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant),
Adjuvanted], is approved in the U.S. for prevention of infection
caused by all known subtypes of hepatitis B virus in adults age 18
years and older. Dynavax's lead immunotherapy product,
SD-101, is an investigational cancer immunotherapeutic currently
being evaluated in Phase 1/2 studies and its second cancer
immunotherapeutic, DV281, is in Phase 1 development. For more
information, visit www.dynavax.com.
Forward-Looking Statements This
press release contains "forward-looking" statements, including
statements regarding HEPLISAV-B and the potential timing of an EMA
review decision. These statements are subject to a number of risks,
including whether the EMA will find the submission to be complete
or whether it will seek further information, including the conduct
of additional clinical trials; whether it will complete its review
of the MAA within the anticipated timeframe; and whether the
outcome of its review will be an approval, as well as other risks
detailed in the "Risk Factors" section of our Annual Report on Form
10-K for the fiscal year ended December 31, 2018, 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. Information on
Dynavax's website at www.dynavax.com is not incorporated by
reference in our current periodic reports with the SEC.
Contact: Heather Rowe Vice
President, Investor Relations & Corporate Communications
hrowe@dynavax.com 510-665-7269
___________________________________________________i CDC.
https://www.cdc.gov/hepatitis/hbv/bfaq.htm.ii CDC.
https://www.cdc.gov/hepatitis/hbv/hbvfaq.htm.
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