Dynavax and Merck Announce Partnership to Develop HEPLISAV

Dynavax Technologies Corporation (Berkeley, CA) and Merck & Co., Inc. (Whitehouse Station, NJ) have announced a global license and development collaboration agreement to jointly develop HEPLISAV, an investigational hepatitis B vaccine that is currently being evaluated in a multi-center Phase 3 clinical trial involving adults and in patients on dialysis.

Under the terms of the agreement, Merck receives worldwide exclusive rights to HEPLISAV, will fund future vaccine development, and will be responsible for commercialization. Dynavax will receive an initial payment of $31.5 million, and will be eligible to receive up to $105 million in development and sales milestone payments, and double-digit tiered royalties on global sales of HEPLISAV.

Under Merck's oversight, Dynavax will continue to manage the ongoing Phase 3 studies in Canada and Europe as well as other licensure-required studies. The US Food and Drug Administration biologics licensing application 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 Düsseldorf, Germany, facility using Dynavax's proprietary technology developed there and later, at a new facility to support expected market needs.