<SEC-DOCUMENT>0001181431-12-019767.txt : 20120328
<SEC-HEADER>0001181431-12-019767.hdr.sgml : 20120328
<ACCEPTANCE-DATETIME>20120327181309
ACCESSION NUMBER:		0001181431-12-019767
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20120327
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20120328
DATE AS OF CHANGE:		20120327

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:		12718188

	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
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>rrd340037.htm
<DESCRIPTION>8-K
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			Prepared By R.R. Donnelley Financial -- Form 8-K
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				<b>UNITED STATES </b>
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				<b>SECURITIES AND EXCHANGE COMMISSION</b>
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				<b>Washington, D.C. 20549</b>
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				<b>Form 8-K </b>
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				<b>CURRENT REPORT</b>
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				<b>Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934</b>
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				<b>Date of Report (Date of earliest event reported):&nbsp;&nbsp;03/27/2012 </b>
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				<b>Dynavax Technologies Corporation</b>
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				<b>(Exact name of registrant as specified in its charter)</b>
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				<b>Commission File Number:&nbsp;&nbsp;001-34207</b>
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								<b>Delaware</b>
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							&nbsp;&nbsp;
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								<b>33-0728374</b>
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								<b>(State or other jurisdiction of</b>
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								<b>(IRS Employer</b>
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								<b>incorporation)</b>
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								<b>Identification No.)</b>
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				<b>2929 Seventh Street, Suite 100</div><div Align="center">Berkeley, CA 94710-2753</b>
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				<b>(Address of principal executive offices, including zip code)</b>
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				<b>(510) 848-5100</b>
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				<b>(Registrant&#146;s telephone number, including area code)</b>
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				<b> </b>
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				<b>(Former name or former address, if changed since last report)</b>
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			<b>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:<BR><BR></b>
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			<b>[&nbsp;&nbsp;]&nbsp;&nbsp;
			Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)<BR><BR>
			[&nbsp;&nbsp;]&nbsp;&nbsp;
			Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)<BR><BR>
			[&nbsp;&nbsp;]&nbsp;&nbsp;
			Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))<BR><BR>
			[&nbsp;&nbsp;]&nbsp;&nbsp;
			Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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				<b>Item 8.01.&nbsp;&nbsp;&nbsp;&nbsp;Other Events</b>
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				On March 27, 2012, we issued a press release titled "Dynavax Reports Final Phase 3 Data for HEPLISAV in CKD Patients and New Data from Booster Trial in Hemodialysis Patients." A copy of the press release is attached as Exhibit 99.1 to this current report and is incorporated herein by reference.
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				<b>Item 9.01.&nbsp;&nbsp;&nbsp;&nbsp;Financial Statements and Exhibits</b>
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				(d) Exhibits</div><div align="left" style="text-indent:4%">Exhibit No.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Description</div><div align="left" style="text-indent:4%">99.1&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Press Release, dated March 27, 2012, titled "Dynavax Reports Final Phase 3 Data for HEPLISAV in CKD Patients and New Data from Booster Trial in Hemodialysis Patients."
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			<b>SIGNATURES</b>
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			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.
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							Dynavax Technologies Corporation
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					&nbsp;
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							Date: March 28, 2012
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							By:
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					&nbsp;
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						/s/&nbsp;&nbsp;&nbsp;&nbsp;Michael S. Ostrach </font>
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						Michael S. Ostrach </font>
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						Vice President
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			<b>EXHIBIT INDEX</b>
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								<b>Exhibit&nbsp;No.</b>
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								<b>Description</b></font>
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								EX-99.1
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								Dynavax Reports Final Phase 3 Data for HEPLISAV in CKD Patients and New Data from Booster Trial in Hemodialysis Patients.</font>
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</DOCUMENT>
<DOCUMENT>
<TYPE>EX-99
<SEQUENCE>2
<FILENAME>rrd340037_37435.htm
<DESCRIPTION>DYNAVAX REPORTS FINAL PHASE 3 DATA FOR HEPLISAV IN CKD PATIENTS AND NEW DATA FROM BOOSTER TRIAL IN HEMODIALYSIS PATIENTS.
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<B><P ALIGN="RIGHT">Exhibit 99.1</P>
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</FONT><P ALIGN="RIGHT">    <B><FONT SIZE=2 COLOR="#008080"><FONT SIZE=2 COLOR="#008080">    2929 Seventh Street, Suite 100   </P>
<P ALIGN="RIGHT">             Berkeley, CA 94710</P>
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<B><FONT FACE="Arial" SIZE=3><FONT FACE="Arial" SIZE=3><P>Contact:</B></FONT></FONT></TD>
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<FONT FACE="Arial" SIZE=3><FONT FACE="Arial" SIZE=3><P>Michael Ostrach</FONT></FONT></TD>
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<FONT FACE="Arial" SIZE=3><FONT FACE="Arial" SIZE=3><P>Vice President and Chief Business Officer </FONT></FONT></TD>
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<FONT FACE="Arial" SIZE=3><FONT FACE="Arial" SIZE=3><P>510-665-7257</FONT></FONT></TD>
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<FONT FACE="Arial" SIZE=3><FONT FACE="Arial" SIZE=3><P>mostrach@dynavax.com</FONT></FONT></TD>
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<P ALIGN="CENTER">&nbsp;</P>
<P ALIGN="CENTER"><A NAME="OLE_LINK9">DYNAVAX REPORTS FINAL PHASE 3 DATA FOR HEPLISAV<SUP>TM</SUP> IN CKD PATIENTS AND NEW DATA FROM BOOSTER TRIAL IN HEMODIALYSIS PATIENTS</P>
</B><P>BERKELEY, CA - March 27, 2012 - Dynavax Technologies Corporation (NASDAQ: DVAX) today announced final data from a pivotal Phase 3 trial in patients with chronic kidney disease (CKD) demonstrating early seroprotection and the durability of the immune response to HEPLISAV compared to Engerix-B&reg;. In October 2011, Dynavax reported that the superiority endpoint had been met in this trial. The trial included 516 patients 18-75 years of age with CKD (stage 3b or higher) in the U.S., Canada and Germany who received 3 doses of HEPLISAV at 0, 1 and 6 months or 4 double doses of Engerix-B at 0, 1, 2 and 6 months (8 doses total). </P>
<P>Analysis of the final data demonstrated that:  </P>
<UL>
<LI>HEPLISAV provided seroprotection to 90% of patients compared to 82% for Engerix-B (P=0.01) at the primary endpoint (7 months), 1 month after the 3rd dose of HEPLISAV and the 8th dose of Engerix-B. This result demonstrated the previously reported superiority of HEPLISAV seroprotection over Engerix-B.</LI>
<LI>HEPLISAV provided seroprotection to more than twice as many patients (HEPLISAV: 48%; Engerix-B: 20%) at 2 months, 1 month after the 2nd dose of HEPLISAV and the 4th dose of Engerix-B. This result confirmed the earlier seroprotection of HEPLISAV in this population.</LI>
<LI>The geometric mean concentration (GMC) of antibody, which is commonly used to predict the duration of protection in patients with CKD, was approximately four-fold higher in the HEPLISAV group compared to the Engerix-B group. At Week 28, the GMC for HEPLISAV was 448 mIU/mL compared to the Engerix-B GMC of 109 mIU/mL. At one year, six months after completing the 3-dose regimen of HEPLISAV, the GMC was 121 mIU/mL compared to a GMC of 38 mIU/mL six months after completing the 8-dose regimen of Engerix-B.</LI></UL>
<P>In a separate trial, in CKD non-responder patients on hemodialysis who had failed to develop seroprotection after two or more previous vaccination series with the licensed vaccines, new data showed a higher seroprotection rate for HEPLISAV compared to each of Fendrix&reg; and Engerix-B. </P>
</FONT></FONT><FONT FACE="Arial" SIZE=1><FONT FACE="Arial" SIZE=1><P>HEPLISAV is a trademark of Dynavax, and Fendrix&reg; and Engerix-B&reg; are registered trademarks of GlaxoSmithKline.</P>
</FONT></FONT><FONT FACE="Arial" SIZE=3><FONT FACE="Arial" SIZE=3><P>&nbsp;</P>
<P>In this study of 119 patients in Germany, the immune responses were compared 4 weeks after a single booster dose of HEPLISAV or Fendrix or two booster doses of Engerix-B. Data from this booster study showed that HEPLISAV provided seroprotection to 44% of patients (17/39) compared to 31% (13/42) for Fendrix and 21% (8/38) for Engerix-B. </P>
<P>Dynavax President and Chief Medical Officer, Tyler Martin, M.D., said, "These results add to the growing body of evidence of HEPLISAV's advantages. Patients with CKD are difficult to protect with current HBV vaccines, requiring 8 doses of Engerix rather than 3 doses for healthy adults. The pivotal CKD trial demonstrated the same profile as our healthy adult trials: earlier onset of seroprotection, higher peak seroprotection and improved duration. In addition, the results from the booster trial suggest HEPLISAV should be the preferred vaccine in this very difficult to protect population, which represents a substantial proportion of patients on hemodialysis." </P>
<P>Dynavax plans to submit a U.S. Biologics License Application (BLA) for HEPLISAV by the middle of May for an indication in healthy adults 18-70 years of age for a 2-dose vaccination regimen at 0 and 1 month. A supplemental BLA with an indication and 3-dose primary vaccination regimen for patients with CKD will be filed when the initial BLA is approved. </P>
<P>The Advisory Committee on Immunization Practices (ACIP) and other public health authorities recommend vaccination for all persons with end-stage renal disease, including predialysis, hemodialysis, peritoneal dialysis and home dialysis patients. Specific regimens or formulations are recommended for both of the currently available hepatitis B vaccines due to the hypo-responsiveness of CKD patients. For immunocompromised persons, including dialysis patients, it is also recommended that additional vaccine be administered as needed to retain seroprotective levels of antibody against hepatitis B. </P>
<P>There are an estimated 750,000 persons with end-stage kidney disease in the United States and the five major European markets and an annual incidence of 150,000 new diagnoses and entry into dialysis. Dialysis patients typically receive dialysis treatments, vaccination and monitoring of antibody levels through a network of dialysis centers that include approximately 5,000 sites in the United States. </P>
<B><P>About HEPLISAV </P>
</B><P>HEPLISAV is an investigational adult hepatitis B vaccine. 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. </P>
<B><P>About Dynavax </P>
</B><P>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. </P>
<B><P></A>Forward-Looking Statements </P>
</B><P>This press release contains "forward-looking statements," including those relating to the potential benefits and use of HEPLISAV, planned indications and regimens, and timing of BLA submissions, 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 in development or clinical trial enrollment, 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 accepted for filing; the Company's ability to obtain additional financing to support the development and commercialization of HEPLISAV and its other operations, possible claims against the Company 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 the Company's current periodic reports with the SEC. </P>
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