BERKELEY, CA--(Marketwire - July 02, 2012) - Dynavax Technologies Corporation (NASDAQ: 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™ 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® is a registered trademark of the American Medical Association, which develops and maintains CPT codes.
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.
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 www.dynavax.com.
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 www.dynavax.com is not incorporated by reference in our current periodic reports with the SEC.