Dynavax’s HEPLISAV-B® ACIP Recommendations Published in the CDC’s Morbidity and Mortality Weekly Report
April 23 2018 - 6:30AM
Dynavax Technologies Corporation (NASDAQ:DVAX) today announced that
the Centers for Disease Control and Prevention (CDC) published the
Advisory Committee of Immunization Practices’ (ACIP)
Recommendations for the use of HEPLISAV-B® [Hepatitis B Vaccine,
Recombinant (Adjuvanted)] for adults in the US in the Morbidity and
Mortality Weekly Report (MMWR) dated April 19. The publication can
be found on the CDC’s website here.
“Publication in the MMWR represents the final endorsement that
many policies require before they will provide reimbursement, so
institutions are now able to purchase product knowing that they
will be covered for their out of pocket expenses. The response to
HEPLISAV-B we have seen in the market has exceeded our
expectations, providing us with added confidence in our ability to
reach profitability for this product by the end of 2019,” said
Eddie Gray, Chief Executive Officer.
Dynavax commercially launched HEPLISAV-B in the United States in
January 2018 with a 60-person sales force. The vaccine can be
ordered through a broad network of authorized distributors. The
company is working with an extensive network of group purchasing
organizations and government entities to help ensure adult patients
have access to HEPLISAV-B. Dynavax is also working to support broad
reimbursement of HEPLISAV-B by insurance plans. Proactive payer
outreach is currently ongoing and will include the MMWR publication
for HEPLISAV-B now that the ACIP recommendations have been approved
by the CDC and U.S. Department of Health and Human Services (HHS).
Information on authorized distributor and payer-specific coverage
may be accessed by calling 1-84-HEPLISAV (1-844-375-4728), and
speaking to a HEPLISAV-B Access Navigator. HEPLISAV-B Access
Navigators are available Monday–Friday from 8:00am-8:00pm ET.
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 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 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 StatementThis 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; whether payers will provide timely
reimbursement for HEPLISAV-B; whether prescribers and other key
decision-makers will switch to HEPLISAV-B; 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:David BurkeDirector, IR & Corporate
Communications510-665-7269dburke@dynavax.com
US-18-01-00005
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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