Heplisav is currently in Phase III trials.

Dynavax Technologies and Merck agreed to jointly develop Heplisav™, a hepatitis B vaccine currently being in a Phase III  trial.

Dynavax will initially receive $31.5 million and will be eligible to $105 million in development and sales milestone fees as well as double-digit tiered royalties on global sales.

Under the terms of the global license and development agreement, Merck obtains worldwide, exclusive rights to Heplisav, will fund future vaccine development, and be responsible for commercialization.

With 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 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.

Heplisav is based on Dynavax’ immunostimulatory sequence (ISS) that targets toll-like receptor 9 to stimulate an innate immune response. Heplisav combines ISS with HBV surface antigen (HBsAg) and is designed to enhance the speed of protection.

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