Dynavax, Merck say hepatitis B virus vaccine meets primary targets in late stage study - Quick Facts

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Dynavax, Merck say hepatitis B virus vaccine meets primary targets in late stage

study - Quick Facts

8/5/2008 4:34 PM ET

(RTTNews) - Tuesday, Dynavax Technologies Corp.(DVAX: News, Chart, Quote ) said

the experimental hepatitis B virus vaccine -- HEPLISAV, which it is

co-developing with Merck, achieved its primary goals in a late stage clinical

trial. The study compared HEPLISAV with Engerix-B -- a currently marketed

hepatitis B virus vaccine.

HEPLISAV is being jointly developed by Dynavax and Merck for use in adults and

in patients with end stage renal disease.

The multi-center study, which evaluated 2,427 subjects from 11 to 55 years of

age in Canada and Germany, aimed to determine the proportion of subjects who

developed protective antibodies to hepatitis B after administration.

In the study, a two-dose regimen of HEPLISAV was administered to patients at 0

and 1 month and a three-dose regimen of Engerix-B was administered at 0, 1 and 6

months.

About 95.1% of subjects who received two doses of HEPLISAV developed protective

antibodies to hepatitis B when measured at 12 weeks compared to just 81.1% of

subjects who received three doses of Engerix-B, when measured at 28 weeks, the

company noted.

The company plans to present results of additional analyses from this trial in

the future.

As previously disclosed, the FDA has placed a clinical hold on the two

Investigational New Drug Applications for HEPLISAV that is still in effect.

by RTT Staff Writer

For comments and feedback: contact editorial@...

[Guest guest]

http://www.rttnews.com/ArticleView.aspx?Id=675294 & SMap=1

Dynavax, Merck say hepatitis B virus vaccine meets primary targets in late stage

study - Quick Facts

8/5/2008 4:34 PM ET

(RTTNews) - Tuesday, Dynavax Technologies Corp.(DVAX: News, Chart, Quote ) said

the experimental hepatitis B virus vaccine -- HEPLISAV, which it is

co-developing with Merck, achieved its primary goals in a late stage clinical

trial. The study compared HEPLISAV with Engerix-B -- a currently marketed

hepatitis B virus vaccine.

HEPLISAV is being jointly developed by Dynavax and Merck for use in adults and

in patients with end stage renal disease.

The multi-center study, which evaluated 2,427 subjects from 11 to 55 years of

age in Canada and Germany, aimed to determine the proportion of subjects who

developed protective antibodies to hepatitis B after administration.

In the study, a two-dose regimen of HEPLISAV was administered to patients at 0

and 1 month and a three-dose regimen of Engerix-B was administered at 0, 1 and 6

months.

About 95.1% of subjects who received two doses of HEPLISAV developed protective

antibodies to hepatitis B when measured at 12 weeks compared to just 81.1% of

subjects who received three doses of Engerix-B, when measured at 28 weeks, the

company noted.

The company plans to present results of additional analyses from this trial in

the future.

As previously disclosed, the FDA has placed a clinical hold on the two

Investigational New Drug Applications for HEPLISAV that is still in effect.

by RTT Staff Writer

For comments and feedback: contact editorial@...