Dynavax Reports New CPT Code for Adult Two Dose Hepatitis B Vaccination Schedule
BERKELEY, CA, Jul 02, 2012 (MARKETWIRE via COMTEX) -- Dynavax Technologies
Corporation (DVAX) today announced that the American Medical Association (AMA)
Current Procedural Terminology (CPT) Panel has established a CPT code for an
adult 2 dose hepatitis B vaccination schedule. HEPLISAV(TM) will be reported
using the new code, differentiating it from a 3 dose hepatitis B vaccine
schedule. The revision has been posted to the AMA website.
Dynavax also reported that the proposed proprietary name, HEPLISAV, has been
tentatively accepted for use in the U.S. by the Food and Drug Administration
(FDA) and also accepted as valid in the E.U. by the Committee for Medicinal
Products for Human Use.
Tyler Martin, President and Chief Medical Officer, said: "These developments are
key steps in ensuring a smooth commercialization process for HEPLISAV. The CPT
code distinguishes our vaccine candidate from existing vaccines, which can help
streamline reimbursement and may facilitate adoption by providers. Additionally,
we believe that approval of our preferred name, HEPLISAV, in the E.U. and
preliminary acceptance in the U.S. will allow us to capitalize on our already
existing name recognition and simplify the product launch process."
CPT codes are used by medical practitioners, including physicians, hospitals, and
other health care providers, to report medical, surgical, and diagnostic services
and procedures to insurers for the purpose of reimbursement. This standardized
nationwide system of coding provides a uniform language for reporting medical
services. CPT(R) is a registered trademark of the American Medical Association,
which develops and maintains CPT codes.
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine for which a U.S. BLA has
been accepted for review by the FDA and a European Marketing Authorization
Application (MAA) is expected to be submitted in the third quarter of 2012. In
Phase 3 trials, HEPLISAV demonstrated higher and earlier protection with fewer
doses than currently licensed vaccines. Dynavax has worldwide commercial rights
to HEPLISAV. HEPLISAV combines hepatitis B surface antigen with a proprietary
Toll-like Receptor 9 agonist to enhance the immune response.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company,
discovers and develops novel products to prevent and treat infectious and
inflammatory diseases. The Company's lead product candidate is HEPLISAV, a Phase
3 investigational adult hepatitis B vaccine designed to provide higher and
earlier protection with fewer doses than currently licensed vaccines. A U.S. BLA
for HEPLISAV has been accepted for review by the FDA. For more information visit
dynavax.com.
Forward-Looking Statements
This press release contains "forward-looking statements," including those
relating to the new CPT code, the proprietary trade name, HEPLISAV, and the
commercialization process, that are subject to a number of risks and
uncertainties. Actual results may differ materially from those set forth in this
press release due to the risks and uncertainties inherent in our business,
including whether successful clinical and regulatory development and approval of
HEPLISAV and our process for its manufacture can occur in a timely manner or
without significant additional studies or difficulties or delays; whether our
studies can support registration for commercialization of HEPLISAV; the results
of clinical trials and the impact of those results on the initiation and
completion of subsequent trials and issues arising in the regulatory process,
including whether the BLA will be approved and the trade name finally accepted;
our ability to obtain additional financing to support the development and
commercialization of HEPLISAV and our other operations; our ability to
successfully transition to a commercial operation and execute on our commercial
strategy; possible claims against us, including enjoining sales of HEPLISAV,
based on the patent rights of others; and other risks detailed in the "Risk
Factors" section of our current periodic reports with the SEC. 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 dynavax.com is not incorporated by
reference in our current periodic reports with the SEC. |
