Dynavax Technologies Corporation (NASDAQ:DVAX) today announced that
HEPLISAV-B™ [Hepatitis B Vaccine (Recombinant), Adjuvanted] is now
available in the United States for the prevention of infection
caused by all known subtypes of hepatitis B virus in adults age 18
years and older. HEPLISAV-B was approved by the U.S. Food and Drug
Administration (FDA) on November 9, 2017. It is the first new
hepatitis B vaccine in the United States in more than 25 years and
the only two-dose hepatitis B vaccine for adults.
“Dynavax is prepared and proud to launch our first product,
HEPLISAV-B, in the United States,” said Eddie Gray, chief executive
officer of Dynavax. “We believe the increase in the rate of
infections and poor compliance with current three-shot regimens has
the medical community eager for access to HEPLISAV-B for adults.
Given its two-dose schedule and delivery of high rates of
protection, HEPLISAV-B is an important tool for preventing
hepatitis B in the United States.”
HEPLISAV-B can now be ordered through a network of distributors,
which will broaden over the next few weeks. The Wholesale
Acquisition Cost (WAC) for HEPLISAV-B of $115 per dose, or $230 per
regimen, reflects the value HEPLISAV-B brings to the healthcare
system. Dynavax is currently working with an extensive network of
group purchasing organizations and government entities to ensure
all patients have access to HEPLISAV-B. A list of the current
distributors in the Dynavax network can be accessed by calling
1-84-HEPLISAV (1-844-375-4728).
Dynavax has begun activities to support broad reimbursement of
HEPLISAV-B by insurance plans. Importantly, the American Medical
Association has published a new and active Current Procedural
Terminology (CPT) code for a two-dose adult hepatitis B vaccine,
which was created to accommodate HEPLISAV-B’s two-dose, one-month
schedule. A majority of plans currently have this unique code
loaded into their claims processing systems. Some plans will
require recommendation from the CDC’s Advisory Committee on
Immunization Practices (ACIP) prior to covering HEPLISAV-B. The
next ACIP meeting is scheduled for February 21-22, 2018. Proactive
payer outreach is currently ongoing, and will include updated ACIP
information specific to HEPLISAV-B as it becomes available. Dynavax
has staged the deployment of its field sales team to coincide with
the upcoming ACIP meeting.
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. 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 vaccination for those at high risk for infection due to
their jobs, lifestyle, living situations and travel to certain
areas.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-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.
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 DynavaxDynavax 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 commercial launch 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
launch HEPLISAV-B; whether payers will provide timely reimbursement
for HEPLISAV-B; whether the CDC’s Advisory Committee on
Immunization Practices (ACIP) will add HEPLISAV-B to its adult
vaccination schedule during its February 2018 meeting, or at all;
and whether potential claims against us, including those based on
patent rights of others, will result in an injunction against sales
or otherwise impact commercialization and sales. 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.
Contact: Ryan SpencerVP, Corporate Strategy
& Communications510.665.4618rspencer@dynavax.com
Media Contact:Rachel St. MartinW2O wcg
646.894.5757 rstmartin@w2ogroup.com
i CDC. https://www.cdc.gov/hepatitis/hbv/bfaq.htm.
ii CDC.
https://www.cdc.gov/hepatitis/statistics/2015surveillance/index.htm#tabs-5-8.
Fig 3.2
iii CDC. https://www.cdc.gov/hepatitis/hbv/hbvfaq.htm.
iv CDC.
https://www.cdc.gov/diabetes/pubs/pdf/hepb_vaccination.pdf.
v CDC.
https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf.
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