Dynavax's hepatitis B vaccine gets FDA nod on third try, shares up

(Reuters) - Dynavax Technologies Corp’s hepatitis B vaccine won the U.S. Food and Drug Administration’s approval on the third attempt and Chief Executive Eddie Gray told Reuters the company was open to, but not waiting for, a partner to market the drug.

The two-dose vaccine, Heplisav-B, will be Dynavax’s first drug to come to market and its approval comes after two FDA rejections, first in February 2013 and then in November 2016.

The company’s shares jumped 16.5 percent to $23.35 in extended trading on Thursday.

Reuters reported in September that Dynavax was exploring strategic options, including a sale or licensing deal, for Heplisav-B, which is designed to enhance the body’s immune response to the hepatitis B virus in adults.

Gray told Reuters he is willing to discuss any proposal for a potential partnership on the drug, but said Dynavax is not waiting for approaches and is moving ahead with a launch in the first quarter of 2018.

“The adult vaccine market is an ideal market opportunity for Dynavax to become a commercial entity and to be highly successful with Heplisav-B,” Gray said.

The vaccine will compete directly with GlaxoSmithKline Plc’s Engerix-B, a three-dose vaccine that currently dominates the market.

William Blair analyst Katherine Xu believes Heplisav-B has the potential to become the next standard of care and could reach peak sales of about $600 million in the United States.

“The two-dose vaccine ... is really a game changer,” Xu said, adding that Heplisav-B could capture 80 percent of the market over the next couple of years.

Hepatitis B affected about 3,370 patients in 2015, latest data from the Centers for Disease Control and Prevention showed.

The virus can lead to cirrhosis of the liver, cancer and even death. It spreads through sexual contact, sharing needles or syringes and from mother to baby during pregnancy.

A panel of independent advisers to the FDA in July had voted in favor of the safety of and recommended approving Heplisav-B.

Reporting by Divya Grover in Bengaluru; Editing by Savio D’Souza