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UPDATE 1-Dynavax hepatitis B vaccine as safe as Glaxo's vaccine
March 23, 2010 / 10:40 AM / 7 years ago

UPDATE 1-Dynavax hepatitis B vaccine as safe as Glaxo's vaccine

* No difference in autoimmune adverse events of two vaccines

* Shares up 21 pct in premarket trade

March 23 (Reuters) - Dynavax Technologies Corp (DVAX.O) said the safety profile of its experimental hepatitis B vaccine Heplisav was comparable with GlaxoSmithKline Plc’s (GSK.L) hepatitis B vaccine Engerix-B, which recently got a regulatory approval.

The company said there was no difference in autoimmune adverse events between subjects vaccinated with Heplisav and Glaxo’s vaccine.

Hepatitis B is a chronic disease, which can lead to cirrhosis of the liver. There is no cure for the condition.

Dynavax is developing Heplisav for populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease.

In March 2008, U.S. Food and Drug Administration had put a clinical hold on the vaccine. It is currently in late-stage trials, after the FDA removed the hold last September.

Dynavax said the safety data was originally prepared for regulatory submission as part of a documentation that formed the basis upon which Heplisav’s clinical development was allowed to resume in late 2009.

Shares of the company were up 21 percent to $1.54 in premarket trade. They closed at $1.27 Monday on Nasdaq. (Reporting by Esha Dey in Bangalore; Editing by Anil D‘Silva)

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