Under the terms of the agreement, Merck receives worldwide exclusive rights to Heplisav, will fund future vaccine development and 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 III studies in Canada and Europe as well as other licensure-required studies. The FDA 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.
Dino Dina, CEO and president of Dynavax, said: “Based on the clinical profile demonstrated by Heplisav, we believe that this vaccine could represent an important advancement in the field. We wanted to partner with Merck given Merck’s commitment to public health and leadership in bringing innovative vaccines to the market. Importantly, we expect it to be the first marketed product containing a novel toll-like receptor 9 agonist.”