0001181431-12-037989.txt : 20120626 0001181431-12-037989.hdr.sgml : 20120626 20120626162100 ACCESSION NUMBER: 0001181431-12-037989 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20120626 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20120626 DATE AS OF CHANGE: 20120626 FILER: COMPANY DATA: COMPANY CONFORMED NAME: DYNAVAX TECHNOLOGIES CORP CENTRAL INDEX KEY: 0001029142 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 330728374 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-34207 FILM NUMBER: 12927439 BUSINESS ADDRESS: STREET 1: 2929 SEVENTH STREET STREET 2: SUITE 100 CITY: BERKELEY STATE: CA ZIP: 94710 BUSINESS PHONE: 5108485100 MAIL ADDRESS: STREET 1: 2929 SEVENTH STREET STREET 2: SUITE 100 CITY: BERKELEY STATE: CA ZIP: 94710 8-K 1 rrd349639.htm 8-K Prepared By R.R. Donnelley Financial -- Form 8-K
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
Form 8-K
 
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported):  06/26/2012
 
Dynavax Technologies Corporation
(Exact name of registrant as specified in its charter)
 
Commission File Number:  001-34207
 
Delaware
  
33-0728374
(State or other jurisdiction of
  
(IRS Employer
incorporation)
  
Identification No.)
 
2929 Seventh Street, Suite 100
Berkeley, CA 94710-2753
(Address of principal executive offices, including zip code)
 
(510) 848-5100
(Registrant’s telephone number, including area code)
 
(Former name or former address, if changed since last report)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

[  ]   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

[  ]   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

[  ]   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

[  ]   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 

 
Item 8.01.    Other Events
 
On June 26, 2012, we issued a press release titled "Dynavax Announces FDA Acceptance of HELISAV(TM) BLA." A copy of the press release is attached as Exhibit 99.1 to this current report and is incorporated herein by reference.
 
 
Item 9.01.    Financial Statements and Exhibits
 
(d) Exhibits
Exhibit No.        Description
99.1        Press Release, dated June 26, 2012, titled "Dynavax Announces FDA Acceptance of HELISAV(TM) BLA."
 

 

SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
           
Dynavax Technologies Corporation
 
 
Date: June 26, 2012
     
By:
 
/s/    Michael S. Ostrach

               
Michael S. Ostrach
               
Vice President
 
 


 

EXHIBIT INDEX
 
Exhibit No.

  
Description

EX-99.1
  
Dynavax Announces FDA Acceptance of HEPLISAV(TM) BLA
EX-99 2 rrd349639_37993.htm DYNAVAX ANNOUNCES FDA ACCEPTANCE OF HEPLISAV(TM) BLA 2929 Seventh Street, Suite 100

2929 Seventh Street, Suite 100

Berkeley, CA 94710

Contact:

   

Michael Ostrach

   

Vice President and Chief Business Officer

510-665-7257

mostrach@dynavax.com

 

DYNAVAX ANNOUNCES FDA ACCEPTANCE OF HEPLISAVTM BLA

BERKELEY, CA - June 26, 2012 - Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the Food and Drug Administration (FDA) has accepted for review the U.S. Biologics License Application (BLA) for HEPLISAV, pursuing an indication for immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 through 70 years of age.

Dynavax President and Chief Medical Officer, Tyler Martin, M.D., said, "The FDA has established February 24, 2013, as the PDUFA action date. We look forward to working with the FDA in moving HEPLISAV through the regulatory review process over the next few months."

The Company anticipates submitting a European Marketing Authorization Application (MAA) for HEPLISAV in the third quarter of 2012. Upon approval of the HEPLISAV BLA, Dynavax plans to submit a supplemental BLA for an indication in patients with chronic kidney disease.

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. For more information visit www.dynavax.com.

Forward-Looking Statements

This press release contains "forward-looking statements," including those relating to the HEPLISAV MAA submission and supplemental BLA filing, 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 review 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 timely filing of the MAA; 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.

# # #