BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

Dynavax Technologies Corporation (DVAX) Reports New CPT Code for Adult Two Dose Hepatitis B Vaccination Schedule


7/2/2012 8:59:10 AM

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.

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 www.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 www.dynavax.com is not incorporated by reference in our current periodic reports with the SEC.




Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES