The FDA is giving Dynavax Technologies a green light to resume testing of a late-stage hepatitis B vaccine that had been derailed 18 months ago after a patient in one study developed a rare inflammatory autoimmune disease. The regulatory approval will pave the way to a new Phase III trial that compares the effects of a commercially manufactured version of Heplisav with the vaccine used in clinical trials to ensure uniformity. And the CEO of the company says that if everything now stays on track, a new hep B vaccine could be on the market in 2012.
The FDA's move to halt the study of Heplisav dealt a severe wound to the developer. Last fall its stock had fallen to a meager 15 cents a share, a steep plunge from the year before, when it was worth $10 a share. Soon after the news hit the wires that the FDA was lifting its clinical hold, Dynavax's shares surged 36 percent--to $2.39--as investors got a chance to consider the new potential of Heplisav.
The vaccine combines an antigen and an adjuvant designed to target toll-like receptor 9, which spurs the human immune system into action. New late-stage trials will include a Phase III for adults over the age of 40. The market for hep B vaccines is around $500 million worldwide.