Dynavax Technologies Corporation (NASDAQ:DVAX), a leader in
developing immunotherapies based on toll-like receptor (TLR)
biology, and Sam’s Club, a leading membership warehouse club
offering superior products, savings and services to millions of
members in nearly 600 clubs, have teamed up to introduce HEPLISAV-B
into Sam’s Club retail pharmacies nation-wide where pharmacists can
immunize patients. HEPLISAV-B is indicated for prevention of
infection caused by all known subtypes of hepatitis B virus in
adults age 18 years and older. This is the first new hepatitis B
vaccine in the United States in more than 25 years, and
the only two-dose, one-month hepatitis B vaccine for adults.
“Giving our patients access to superior care and value is our
priority,” said David Badeen, Vice President of Healthcare for
Sam’s Club. “Having HEPLISAV-B available at Sam’s Club pharmacies
gives our patients access to an option for vaccination against
hepatitis B that is convenient with just two doses in one month,
while also providing a high level of protection.”
"We recognize community pharmacists, and the retail pharmacy
setting of care, as instrumental to our goal of making HEPLISAV-B
available to adult patients seeking vaccination against hepatitis
B,” said Ryan Spencer, Vice President of Commercial Operations
for Dynavax. “We are excited that Sam’s Club recognizes the
benefits of HEPLISAV-B and that HEPLISAV-B will be available at all
Sam’s Club pharmacy locations. In addition, we are hoping to
collaborate with Sam’s Club to address the important unmet need for
higher levels of protection against hepatitis B in diabetic
patients.”
Please see Important Safety Information below. For more
information about HEPLISAV-B, visit http://heplisavb.com/.
About Sam’s Club
Sam’s Club®, a division of Walmart, Inc. (NYSE: WMT), is a
leading membership warehouse club offering superior products,
savings and services to millions of members in nearly 600 clubs in
the U.S. and Puerto Rico. Now in its 35th year, Sam’s Club
continues to redefine warehouse shopping with its highly curated
assortment of high quality fresh food and Member’s Mark items, in
addition to market leading technologies and services like Scan
& Go, Club Pickup and home delivery service in select markets.
To learn more about Sam’s Club, visit the Sam’s Club Newsroom,
shop at SamsClub.com, and interact with Sam’s Club
on Twitter, Instagram and Facebook.
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.
Hepatitis B is a major public health issue in the United
States, where an estimated 20,000 new infections occur each year,
and approximately 850,000 people are currently living with this
chronic disease.i In 2015, new cases of acute hepatitis B
increased by more than 20 percent nationally.ii 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 that individuals at high risk for
hepatitis B infection due to their jobs, lifestyle, living
situations and travel to certain areas be
immunized.iii 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.iv Approximately 20
million U.S. adults have diabetes, and 1.5 million new
cases of diabetes are diagnosed each year.v
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 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, a hepatitis B vaccine for adults,
is approved in the United States. 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 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.
iCDC. https://www.cdc.gov/hepatitis/hbv/bfaq.htm.
iiCDC. https://www.cdc.gov/hepatitis/statistics/2015surveillance/index.htm#tabs-5-8. Fig
3.2 iiiCDC. https://www.cdc.gov/hepatitis/hbv/hbvfaq.htm.
ivCDC. https://www.cdc.gov/diabetes/pubs/pdf/hepb_vaccination.pdf.
vCDC. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf.
ContactHeather Rowe Vice President, Investor
Relations & Corporate Communications 510-665-7269
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