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):  12/18/2008
 
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 1.02.    Termination of a Material Definitive Agreement
 
On December 19, 2008, Dynavax Technologies Corporation (the "Company") announced the termination of an exclusive license and development collaboration agreement and a related manufacturing agreement (the "Collaboration Arrangement") with Merck & Co., Inc. ("Merck") for HEPLISAV(TM), a Phase 3 hepatitis B virus vaccine. On December 18, 2008, Merck provided notice of its termination of the Collaboration Arrangement between the Company and Merck previously entered into on October 31, 2007. As a result of the termination, all development, manufacturing and commercialization rights to HEPLISAV revert to Dynavax. Merck is obligated to make certain mutually agreed upon payments to Dynavax for the winding down or continuation of the program by Dynavax in the period following Merck's written notice of termination.

As a result of the termination of the Collaboration Arrangement, Dynavax anticipates that it will accelerate the recognition of approximately $31 million of non-cash revenue previously reported as deferre d revenue.

The Company disclosed the material terms of the Collaboration Arrangement and filed copies of the agreements in its Annual Report on Form 10-K for the year ended December 31, 2007 filed with the Securities and Exchange Commission on March 17, 2008.

The foregoing description is qualified in its entirety by reference to the Company's press release dated December 19, 2008, a copy of which is attached hereto as Exhibit 99.1 and incorporated herein by reference.

This current report contains "forward-looking statements," regarding management's expectations, beliefs, goals, plans or the Company's prospects, future financial position, future revenues and projected costs, including the amount of payments that the Company may receive in connection with the termination of the Collaboration Arrangement, timing of recognition of approximately $31 million in revenue and the Company's ability to continue with the program are based upon a number of assumptions, and actual results may materially differ. The Company may also incur material charges not currently contemplated due to events that may occur as a result of, or associated with, the termination. These and other risks are described in greater detail in the "Risk Factors" section of our Quarterly Report on Form 10-Q. The Company undertakes no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

 
 
Item 8.01.    Other Events
 
See Item 1.02

On December 19, 2008, Dynavax issued a press release entitled "Dynavax Announces Termination of Partnership with Merck for HEPLISAV(TM) Hepatitis B Vaccine." 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) Exhibit
Exhibit No.        Description
99.1               Press Release, dated December 19, 2008, Dynavax issued a press release entitled "Dynavax Announces Termination of Partnership with Merck for HEPLISAV(TM) Hepatitis B Vaccine."
 

 

Signature(s)
 
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: December 19, 2008
     
By:
 
/s/    Michael S. Ostrach

               
Michael S. Ostrach
               
Vice President, Chief Business Officer and General Counsel
 
 


 

Exhibit Index
 
Exhibit No.

  
Description

EX-99.1
  
Press Release, dated December 19, 2008, Dynavax issued a press release entitled "Dynavax Announces Termination of Partnership with Merck for HEPLISAV(TM) Hepatitis B Vaccine."
Dynavax Announces Termination of Partnership with Merck

Exhibit 99.1

2929 Seventh Street, Suite 100 Berkeley, CA 94710

Contacts:

   

Dino Dina, M.D.

 

Amy Figueroa

President &

Chief Executive Officer

Investor Relations & Corporate Communications

510-665-4601

510-665-7211

ddina@dynavax.com

afigueroa@dynavax.com

Dynavax Announces Termination of Partnership with Merck for

HEPLISAV™ Hepatitis B Vaccine

- All Rights Revert to Dynavax -

BERKELEY, CA - December 19, 2008 - Dynavax Technologies Corporation (Nasdaq: DVAX) today announced the termination of a global license and development collaboration agreement with Merck & Co., Inc. for HEPLISAV(TM), a Phase 3 hepatitis B virus (HBV) vaccine. All rights to develop and commercialize HEPLISAV revert to Dynavax.

Dynavax will continue to evaluate regulatory options for the development of HEPLISAV indicated for adults outside of the United States and for the global end-stage renal disease markets, which the Company estimates represent approximately 70% of the total market opportunity for this vaccine. If the regulatory feedback is favorable, Dynavax plans to pursue a new partner or financing arrangement to support the completion of HEPLISAV's development for these markets.

"We believe the economics for HEPLISAV, which has been shown to be clinically superior in our trials, favor identifying an appropriate regulatory path in the U.S. and Europe," commented Dino Dina, M.D., President and Chief Executive Officer of Dynavax. "In the first quarter of 2009, we expect to gain additional insight into the regulatory path for HEPLISAV that will enable us to evaluate further development and pursue partnering agreements with potential collaborators or investors. Independently of HEPLISAV, with our current cash position and strong pharmaceutical partnerships, we have the ability to continue to advance our diversified, well-funded pipeline of products to position Dynavax for future success."

Update to 2008 Cash Outlook

Dynavax's consolidated cash, cash equivalents, marketable securities and investments held by Symphony Dynamo, Inc., or total cash, is projected to be over $65 million at December 31, 2008, an increase from the previous guidance of over $50 million. This increase is due to the $10 million initial payment under Dynavax's worldwide strategic alliance with GlaxoSmithKline as well as the Company's conservatively managed cash burn rate. Due to the termination of the Merck partnership, Dynavax anticipates that it will accelerate the recognition of approximately $31 million of non-cash revenue previously reported as deferred revenue.

 

- more -

 

 

About HEPLISAV

HEPLISAV is a Phase 3 hepatitis B vaccine that combines HBV surface antigen (HBsAg) with Dynavax's proprietary immunostimulatory sequences (ISS), which specifically target Toll-Like

Receptor 9 (TLR9) to stimulate an innate immune response. Clinical data demonstrate HEPLISAV's highly effective protection against HBV with a more rapid onset of protection, superior 2-dose regimen, and longer lasting seroprotection compared to current vaccines. In a recent Phase 3 trial, 95% of subjects receiving 2 doses of HEPLISAV were seroprotected compared to 81% of subjects receiving 3 doses of Engerix-B. In 9 clinical trials conducted over a period of nearly 10 years, a total of approximately 2,500 individuals have been vaccinated with more than 5,000 doses of HEPLISAV.

In October 2008, the U.S. Food and Drug Administration (FDA) requested additional information prior to considering further development of HEPLISAV in end-stage renal disease patients but advised that the balance of risk versus potential benefit no longer favors continued clinical evaluation of HEPLISAV in healthy adults and children. The clinical hold on the two U.S. IND Applications for HEPLISAV has been in effect since March 2008 following the FDA's request for a complete review of safety data, including all available information about a single case of Wegener's granulomatosis reported in a Phase 3 clinical trial.

HEPLISAV is not on clinical hold in any market outside of the U.S.

About Dynavax

Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops a diversified, well-funded pipeline of novel Toll-like Receptor (TLR) product candidates. Based on Dynavax's proprietary technology platform, these products specifically modify the innate immune response to infectious, respiratory, autoimmune, and inflammatory diseases. Dynavax's product programs are supported by global partnerships with leading pharmaceutical companies such as GlaxoSmithKline, AstraZeneca AB, and Novartis as well as funding from Symphony Dynamo, Inc. and the National Institutes of Health. For more information visit www.dynavax.com.

Dynavax Forward-Looking Statement

This press release contains "forward-looking statements," including statements related to our plans to evaluate regulatory options for HEPLISAV and the timing of that evaluation, the prospects for HEPLISAV and the determination of whether further clinical development of HEPLISAV will be undertaken, and if undertaken, whether further development can be partnered or financed; and our projected year end cash position. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including difficulties or delays in development, initiation and completion of clinical trials, 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; the scope and validity of patent protection and the possibility of claims against us based on the patent rights of others; our ability to obtain additional financing to support our opera tions; and other risks detailed in the "Risk Factors" section of our Quarterly Report on Form 10-Q. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

 

# # #