MSD and Dynavax announce Heplisav development partnership

Merck, Sharp & Dohme (MSD) and Dynavax Technologies have announced a global licence and development collaboration agreement to jointly develop Heplisav.

Heplisav, an investigational hepatitis B vaccine, is currently being evaluated in a Phase III clinical trial involving adults and in patients on dialysis.

Under the agreement, Merck is to receive worldwide exclusive rights to Heplisav as well as being responsible for future vaccine development and commercialisation.

Dynavax will receive an initial payment of $31.5 million (15 million pounds) and will also be eligible for over $105 million in development and sales milestone payments.

Under Merck’s oversight, Dynavax will also continue to manage ongoing Phase III studies as well as other licensure-required studies.

However both companies will be responsible for the US Food and Drug Administration Biologics Licensing Application and other marketing applications.

Margaret G McGlynn, president of Merck vaccines and infectious disease, illustrated how Merck had led the way in hepatitis B prevention with its Recombivax HB vaccine.

“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.”

Earlier this month, Merck reported its financial results for the third quarter of the year, with the company announcing double-digit growth in revenue and earnings per share.