Dynavax Technologies Corporation
DYNAVAX TECHNOLOGIES CORP (Form: 8-K, Received: 10/05/2011 16:34:38)
 
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):  10/03/2011
 
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 1.01.    Entry into a Material Definitive Agreement
 
On October 4, 2011, Dynavax Technologies Corporation ("Dynavax") entered into a Fourth Amendment to the Agreement dated September 1, 2006 by and between the Company and AstraZeneca AB ("AZ") (the "Agreement") dated as of September 23, 2011 (the "Amendment") pursuant to which Dynavax will manage the early clinical development on behalf of the collaboration, of AZD 1419, a proprietary second-generation TLR-9 agonist for asthma. Development expenses will be funded by AstraZeneca and Dynavax will receive an initial payment of $3 million to begin the clinical program.

Under the terms of the 2006 research collaboration and license agreement and as now amended, AstraZeneca will provide to Dynavax a total of approximately $20 million in payments to cover the cost of clinical development activities through Phase 2a. If AstraZeneca chooses to advance the program following completion of Phase 2a, Dynavax will receive a $20 million milestone payment, and AstraZeneca will retain its rights to develop the candidate therapy and to commercialize the resulting asthma product. Additional remaining milestone payments to Dynavax amount to nearly $100 million. Dynavax will receive royalties on worldwide sales of approved products and will have the opportunity to co-promote the product in the United States.

The foregoing summary of this transaction is not complete and is qualified in its entirety by reference to the Amendment which will be filed with the Dynavax Annual Report on Form 10-K for the year ended December 31, 2011.

On October 5, 2011, the Company issued a press release announcing the Amendment described above. The press release is attached hereto as Exhibit 99.2 and incorporated herein by reference.

 
 
Item 8.01.    Other Events
 
On October 3, 2011, Dynavax issued a press release titled "Dynavax Reports Modified Intent to Treat Analysis From the HEPLISAV(TM) Phase 3 Trial in Healthy Adults Over Age 40". 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 October 3, 2011, titled "Dynavax Reports Modified Intent to Treat Analysis From the HEPLISAV(TM) Phase 3 Trial in Healthy Adults Over Age 40."

99.2        Press Release, dated October 5, 2011, titled "Dynavax and AstraZeneca to AdvanceTLR-9 Agonist into Clinic for Asthma."

 

 

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: October 05, 2011
     
By:
 
/s/    Michael S. Ostrach

               
Michael S. Ostrach
               
Vice President
 
 


 

EXHIBIT INDEX
 
Exhibit No.

  
Description

EX-99.1
  
Press Release, dated October 3, 2011, titled "Dynavax Reports Modified Intent to Treat Analysis From the HEPLISAV(TM) Phase 3 Trial in Healthy Adults Over Age 40."
EX-99.2
  
Press Release, dated October 5, 2011, titled "Dynavax and AstraZeneca to Advance TLR-9 Agonist into Clinic for Asthma."

Exhibit 99.1

DYNAVAX

DYNAVAX TECHNOLOGIES
2929 Seventh Street, Suite 100
Berkeley, CA 94710

  Contact:
Shari Annes
Investor Relations
650-888-0902
sannes@dynavax.com

DYNAVAX REPORTS MODIFIED INTENT TO TREAT ANALYSIS FROM THE HEPLISAV™ PHASE 3 TRIAL IN HEALTHY ADULTS OVER AGE 40

BERKELEY, CA – October 3, 2011 – Dynavax Technologies Corporation (NASDAQ: DVAX) presented yesterday at the 5th Global Vaccine Congress in Seattle, WA an analysis of the modified intent to treat population from its Phase 3 trial (HBV-16), showing the superiority of HEPLISAV vs. Engerix-B®. The previously reported per protocol analysis compared the three consistency lots of HEPLISAV to Engerix-B and included 1123 HEPLISAV and 359 Engerix-B subjects who completed the vaccination regimens according to the protocol. The modified intent to treat (MITT) populations of 1947 HEPLISAV subjects and 476 Engerix-B subjects included all subjects that had received at least one dose of any of the four HEPLISAV lots or Engerix-B and had at least one post vaccination immunogenicity result. The Phase 3 study, HBV-16, was a multi-center, observer-blinded study to determine if the immunogenicity of two doses of HEPLISAV was non-inferior/superior to three doses of Engerix-B by comparing seroprotection rates (SPRs) at eight weeks post last dose.

The data demonstrate HEPLISAV's ability to generate a faster, higher, and longer-lasting response as compared to Engerix-B in both the per protocol and the modified intent to treat populations, as follows:

·       For the MITT population, HEPLISAV provided earlier seroprotection than Engerix-B. At the primary endpoint visit, Week 12 for HEPLISAV and Week 32 for Engerix-B, the SPR in the HEPLISAV group was 89% compared to 69 % in the Engerix-B group.
 
  o       In the previously reported per protocol analysis, at the primary endpoint visit, Week 12 for HEPLISAV and Week 32 for Engerix-B, the SPR in the HEPLISAV group was 90% compared to 71% in the Engerix-B group.
 

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Engerix-B® is a registered trademark of GlaxoSmithKline


·       For the MITT population, HEPLISAV also provided higher rates of seroprotection than Engerix-B. The peak SPR for the HEPLISAV group was 95% at Week 24. The peak SPR for the Engerix-B group was 71% at Week 28.
 
  o       As previously reported for the per protocol analysis, the peak SPR for the HEPLISAV group was 95% at Week 24. The peak SPR for the Engerix-B group was 73% at Week 28.
 
·       For the MITT population, HEPLISAV provided longer-lasting antibody than Engerix-B, and the immune response to HEPLISAV was longer-lasting than the immune response to Engerix-B. The SPR in the HEPLISAV group was 92% at Week 52 while the SPR in the Engerix-B group was 59% at Week 52.
 
  o       As previously reported for the per protocol analysis, the SPR in the HEPLISAV group was 92% at Week 52 while the SPR in the Engerix-B group was 59% at Week 52.
 
·       The safety of HEPLISAV was similar to Engerix-B. The rates of local and systemic post- immunization reactions, adverse events, serious adverse events, and autoimmune adverse events were similar in both groups.
 

According to Tyler Martin, M.D., President and Chief Medical Officer, "The results of the modified intent to treat analysis corroborate the previously reported per protocol analysis and support the robustness of our conclusion that HEPLISAV is superior to Engerix-B in this hyporesponsive population.”

Dynavax will present subgroup analyses of the study's findings at upcoming annual medical meetings, including diabetics at the Infectious Diseases Society of America (IDSA), and other hyporesponsive groups at the American Association for the Study of Liver Diseases (AASLD) later this year.

About HEPLISAV

HEPLISAV is an investigational adult hepatitis B vaccine. In an earlier completed pivotal Phase 3 trial, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV and is developing the vaccine for large, high-value populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as ISS 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 rapid and superior protection with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.

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Forward Looking Statements

This press release contains "forward-looking statements," 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 the outcome of pre-filing discussions with regulatory authorities; 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.

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Exhibit 99.2

DYNAVAX

DYNAVAX TECHNOLOGIES

2929 Seventh Street, Suite 100
Berkeley, CA 94710

  Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
mostrach@dynavax.com

DYNAVAX AND ASTRAZENECA TO ADVANCE TLR-9 AGONIST INTO CLINIC FOR ASTHMA

Berkeley, CA — October 5, 2011 — Dynavax Technologies Corporation (NASDAQ: DVAX) and AstraZeneca have amended their existing Collaboration Agreement to accelerate the initiation of clinical development of AZD 1419, a proprietary second-generation TLR-9 agonist for asthma. Dynavax will manage the early clinical development on behalf of the collaboration, and development expenses will be fully funded by AstraZeneca. Dynavax will receive an initial payment of $3 million to begin the clinical program.

Under the terms of the 2006 research collaboration and license agreement and as now amended, AstraZeneca will provide to Dynavax approximately $20 million in payments to cover the cost of clinical development activities through Phase 2a. If AstraZeneca chooses to advance the program following completion of Phase 2a, Dynavax will receive a $20 million milestone payment, and AstraZeneca will retain its rights to develop the candidate therapy and to commercialize the resulting asthma product. Additional remaining milestone payments to Dynavax amount to nearly $100 million. Dynavax will receive royalties on worldwide sales of approved products and will have the opportunity to co-promote the product in the United States.

AZD 1419 has been selected as the lead clinical candidate to enter formal clinical development based on extensive preclinical studies conducted by Dynavax and AstraZeneca. These include demonstration that AZD 1419 is capable of producing long lasting disease-modifying effects in a mouse model of atopic asthma. Initiation of a Phase 1 study is planned after regulatory requirements are met and clinical materials are released.

According to Maarten Kraan, Vice President, Head of Respiratory & Inflammation, AstraZeneca Research and Development, "New approaches to asthma that have the potential to modify the course of severe respiratory disease represent a significant clinical need. We believe that Dynavax's TLR-9 agonist has potential as an innovative, next-generation therapy that could expand and strengthen our respiratory franchise."

Dino Dina, M.D., Dynavax’s Chief Executive Officer, commented,”The success of this collaborative effort confirms once more the potential of our TLR-9 based therapies. The candidate molecule represents a therapy that has been shown preclinically to modify the course of asthmatic disease and produce long term remissions. With AstraZeneca’s financial support and commitments to success milestones, we can now extend our clinical portfolio with a highly innovative and differentiated drug.”

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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 rapid and superior protection with fewer doses than current licensed vaccines. For more information visit www.dynavax.com .

Forward Looking Statements

This press release contains "forward-looking statements," including statements related to the anticipated timing for the first clinical study in our asthma program, expected payments under our AstraZeneca agreement and the potential features of the Company's TLR-9 agonists. 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 results of completed studies can be replicated in human studies, difficulties or delays in discovery or development, initiation and completion of preclinical or clinical studies, the results of those studies and the impact of those results on the initiation and completion of subsequent studies and issues arising in the regulatory process; achieving our AstraZeneca agreement objectives; our ability to obtain additional financing to support our operations; and other risks detailed in the "Risk Factors" section of our current periodic reports filed 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.

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