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Under the terms of the agreement, Merck receives worldwide exclusiverights to HEPLISAV, will fund future vaccine development, and be responsiblefor commercialization. Dynavax will receive an initial payment of $31.5million, and will be eligible to receive up to $105 million in development andsales milestone payments, and double-digit tiered royalties on global sales ofHEPLISAV.
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"Based on the clinical profile demonstrated by HEPLISAV, we believe thatthis vaccine could represent an important advancement in the field," said DinoDina, chief executive officer and president of Dynavax. "In clinical trialsto date, it has conferred immunogenicity after only two doses while retainingtolerability comparable to a currently marketed hepatitis B vaccine. Wewanted to partner with Merck given Merck's commitment to public health andleadership in bringing innovative vaccines to the market. Importantly, weexpect it to be the first marketed product containing a novel Toll-LikeReceptor 9 agonist."
Under Merck's oversight, Dynavax will continue to manage the ongoingPhase 3 studies in Canada and Europe as well as other licensure-requiredstudies. The United States Food and Drug Administration Biologics LicensingApplication (BLA) and other marketing applications will be the jointresponsibility of Merck and Dynavax, and will be filed by Merck. Dynavax willbe responsible for manufacture of the hepatitis B surface antigen component ofthe vaccine for Merck, which will be produced at Dynavax Europe's Dusseldorf,Germany facility using Dynavax's proprietary technology developed there andlater, at a new facility to support expected market needs.
"Merck has been a leader in the field of hepatitis B prevention since weintroduced the first recombinant vaccine, Recombivax HB(R), in 1986," saidMargaret G. McGlynn, president, Merck vaccines and infectious disease."Through this collaboration with Dynavax, we have now gained rights toHEPLISAV, and as a result, have the potential to add another important advanceto 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 byvisiting the investor relations section of the Company's Web site athttp://investors.dynavax.com/events.cfm. A replay of the webcast will beavailable on the Dynavax web site approximately two hours after completion ofthe call and will be archived for two weeks on the Investor page of theDynavax website.
About HEPLISAV
HEPLISAV is based on Dynavax's proprietary immunostimulatory sequence(ISS) that specifically targets Toll-Like Receptor 9 (TLR9) to stimulate aninnate immune response. HEPLISAV combines ISS with HBV surface antigen (HBsAg)and is designed to enhance the speed of protection. HEPLISAV is currentlybeing studied in a Phase 3 trial in Canada and in Europe. Dynavax reported inmid-July 2007 that this international Phase 3 trial in Europe and Canada hadcompleted enrollment.
About Hepatitis B
Hepatitis B is a serious disease that affects the liver. It is caused bythe hepatitis B virus. Hepatitis B virus is spread through contact with theblood or other body fluids of an infected person. A person can becomeinfected by: contact with a mother's blood and body fluids at the time ofbirth; contact with blood and body fluids through breaks in the skin such asbites, cuts, or sores; contact with objects
