0001181431-12-047129.txt : 20120823 0001181431-12-047129.hdr.sgml : 20120823 20120823115234 ACCESSION NUMBER: 0001181431-12-047129 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20120822 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20120823 DATE AS OF CHANGE: 20120823 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: 121051449 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 rrd354160.htm MAA ACCEPTANCE 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):  08/22/2012
 
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 August 22, 2012, we issued a press release titled "Dynavax Marketing Authorization for HEPLISAV(TM) Accepted for Review by European Medicines Agency." 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. The following exhibit is furnished herewith:

99.1    Press Release, dated August 22, 2012, titled "Dynavax Marketing Authorization for HEPLISAV(TM) Accepted for Review by European Medicines Agency."

 

 

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: August 23, 2012
     
By:
 
/s/    Michael Ostrach
               
Michael Ostrach
               
Vice President and Chief Business Officer
 
 

 

EXHIBIT INDEX
 
Exhibit No.
  
Description
EX-99.1
  
Press release dated August 22, 2012, titled "Dynavax Marketing Authorization Application for HEPLISAV(TM) Accepted for Review by European Medicines Agency."
EX-99 2 rrd354160_38374.htm PRESS RELEASE DATED AUGUST 22, 2012, TITLED "DYNAVAX MARKETING AUTHORIZATION APPLICATION FOR HEPLISAV(TM) ACCEPTED FOR REVIEW BY EUROPEAN MEDICINES AGENCY." Contact:

Contact:

    

Michael Ostrach

    

Vice President and Chief Business Officer

510-665-7257

mostrach@dynavax.com

 

DYNAVAX MARKETING AUTHORIZATION APPLICATION FOR HEPLISAVTM ACCEPTED FOR REVIEW BY EUROPEAN MEDICINES AGENCY

BERKELEY, CA - August 22, 2012 - Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that the European Medicines Agency (EMA) has accepted the filing of the Marketing Authorization Application (MAA) 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 and in patients with chronic kidney disease. Acceptance of the MAA confirms that the submission is sufficiently complete to permit a substantive review by the EMA.

"This milestone marks the initiation of the regulatory review for HEPLISAV in Europe," said Dynavax President and Chief Medical Officer, Tyler Martin, M.D. "We look forward to working through the review process with our designated rapporteur from Sweden and co-rapporteur from Belgium."

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 MAA has been accepted for review by the EMA. 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 may contain "forward-looking statements". 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 and MAA will be approved; 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.

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