Delaware | 33-0728374 | |
(State or other jurisdiction of | (IRS Employer | |
incorporation) | Identification No.) |
[ ] 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))
The information with respect to item 2.02 in this current report and its accompanying exhibit shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this current report and in the accompanying exhibit shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by Dynavax Technologies Corporation, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Corporate Update
Phase 3 HEPLISAVTM hepatitis B vaccine - Dynavax is seeking clarification of the remaining regulatory requirements for development and licensure of HEPLISAV in the United States and Europe and expects to have sufficient information in the first half of 2009 to determine a path forward, if any. Concurrently, Dynavax is pursing potential pharmaceutical partnerships and financing arrangements to complete clinical development if the regulatory feedback is positive. Dynavax also expects to report complete Phase 3 PHAST clinical study data from healthy adults in the second quarter of 2009.
Phase 1b SD-101 hepatitis C therapy - In mid-year 2009, Dynavax expects to report top-line data from an ongoing Phase 1b trial for SD-101 therapy for hepatitis C virus (HCV). This trial is being funded entirely under the Symphony Dynamo Inc. (SDI) arrangement.
Phase 1b DV-601 hepatitis B therapy - In mid-year 2009, Dynavax expects to begin enrolling patients in a Phase 1b trial for DV-601 therapy for hepatitis B virus (HBV).
Phase 1a studies - In the second half of 2009, Dynavax expects phase 1a studies will be initiated for AZD1419 for asthma, under a partnership with AstraZeneca, and DV1079 for autoimmune and inflammatory diseases, under a partnership with GlaxoSmithKline. In the first half of 2010, the Company plans to initiate a Phase 1a study for its Universal Flu vaccine, which is under a supply and option agreement with Novartis.
Dynavax Technologies Corporation | ||||||||
Date: March 02, 2009 | By: | /s/ Deborah A. Smeltzer | ||||||
Deborah A. Smeltzer | ||||||||
Vice President, Operations and Chief Financial Officer | ||||||||
Exhibit No. | Description | |
EX-99.1 | Press Release, dated March 2, 2009 titled "Dynavax Announces Fourth Quarter and Year-End 2008 Financial Results." |