Dynavax Technologies has been talking with regulators in Europe about the potential for developing Heplisav, an experimental hepatitis B vaccine, for people over 40 who aren't responding to currently marketed therapies.
"As we advance our development plans for Heplisav, EMEA's scientific advice supports expansion of our targeted population in Europe to include subjects who need rapid protection against hepatitis B infection," commented Dino Dina, M.D., the CEO of Dynavax. "A vaccine that demonstrates potential to provide faster and better protection than current vaccines could transform vaccination regimens and outcomes, particularly for individuals with increased risk of infection."
Dynavax had been in a development pact with Merck, which dropped out late last year after the FDA put a clinical trial for Heplisav on hold. Dynavax is also exploring the FDA's interest in getting a study back underway for patients who aren't responding.
In the meantime, the developer has been squabbling with Merck over its decision to dump the partnership. Merck paid Dynavax $31.5 million when it signed on, and Dynavax says it's owed more, according to the San Francisco Business Times. "Merck has disagreed with the amounts for which it may be liable under the agreement and we are currently in negotiations to determine the amount of the wind down payment," said Dynavax in its last quarterly report.
- check out the Dynavax release
- read the story from the San Francisco Business Times