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Dynavax and Merck & Co., Inc. Announce Partnership to Develop HEPLISAV(TM), an Investigational Hepatitis B Vaccine Currently in Phase 3
Date:11/1/2007

inue to manage the ongoing Phase 3 studies in Canada and Europe as well as other licensure-required studies. The United States Food and Drug Administration Biologics Licensing Application (BLA) and other marketing applications will be the joint responsibility of Merck and Dynavax, and will be filed by Merck. Dynavax will be responsible for manufacture of the hepatitis B surface antigen component of the vaccine for Merck, which will be produced at Dynavax Europe's Dusseldorf, Germany facility using Dynavax's proprietary technology developed there and later, at a new facility to support expected market needs.

"Merck has been a leader in the field of hepatitis B prevention since we introduced the first recombinant vaccine, Recombivax HB(R), in 1986," said Margaret G. McGlynn, president, Merck vaccines and infectious disease. "Through this collaboration with Dynavax, we have now gained rights to HEPLISAV, and as a result, have the potential to add another important advance to Merck's broad portfolio of vaccines."

Dynavax Conference Call

Dynavax will webcast its conference call today at 9:00 a.m. ET (6:00 a.m. PT) to discuss the agreement with Merck. The live webcast can be accessed by visiting the investor relations section of the Company's Web site at http://investors.dynavax.com/events.cfm. A replay of the webcast will be available on the Dynavax web site approximately two hours after completion of the call and will be archived for two weeks on the Investor page of the Dynavax website.

About HEPLISAV

HEPLISAV is based on Dynavax's proprietary immunostimulatory sequence (ISS) that specifically targets Toll-Like Receptor 9 (TLR9) to stimulate an innate immune response. HEPLISAV combines ISS with HBV surface antigen (HBsAg) and is designed to enhance the speed of protection. HEPLISAV is currently being studied in a Phase 3 trial in Canada and in Europe. Dynavax reported in m
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SOURCE Dynavax Technologies Corporation
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