Setback in a late-stage trial of hepatitis B vaccine Heplisav

[Guest guest]

http://www.businessweek.com/ap/financialnews/D9OJITHO1.htm

Dynavax shares skid on Heplisav study results

Dynavax reported a setback in a late-stage trial of its hepatitis B vaccine

Heplisav.

Dynavax said Heplisav worked better than an older vaccine, GlaxoKline's

Engerix-B. However the vaccine did not meet one of its " consistency " goals,

which measures the stability of the vaccine over time. The company said one

production lot of Heplisav had a higher concentration of antibodies than the

other two lots after eight weeks. Later in the study, all three lots had similar

consistency.

<edited>

Wedbush analyst Duane Nash said the consistency problem should be solvable, but

he said investors may be unsettled until the Food and Drug Administration offers

its response to Dynavax's study data.

In the trial, 2,449 health adults were given either Heplisav or Engerix-B. The

patients who received Heplisav received one dose at the start of the trial and

another one month later, while the Engerix-B patients received a third dose six

months after the start of the trial. Dynavax said the Heplisav patients had a 90

percent seroprotection rate eight weeks after their last dose. That was better

than the 70 percent protection rate for the Engerix-B patients

<cut>

[Guest guest]

http://www.businessweek.com/ap/financialnews/D9OJITHO1.htm

Dynavax shares skid on Heplisav study results

Dynavax reported a setback in a late-stage trial of its hepatitis B vaccine

Heplisav.

Dynavax said Heplisav worked better than an older vaccine, GlaxoKline's

Engerix-B. However the vaccine did not meet one of its " consistency " goals,

which measures the stability of the vaccine over time. The company said one

production lot of Heplisav had a higher concentration of antibodies than the

other two lots after eight weeks. Later in the study, all three lots had similar

consistency.

<edited>

Wedbush analyst Duane Nash said the consistency problem should be solvable, but

he said investors may be unsettled until the Food and Drug Administration offers

its response to Dynavax's study data.

In the trial, 2,449 health adults were given either Heplisav or Engerix-B. The

patients who received Heplisav received one dose at the start of the trial and

another one month later, while the Engerix-B patients received a third dose six

months after the start of the trial. Dynavax said the Heplisav patients had a 90

percent seroprotection rate eight weeks after their last dose. That was better

than the 70 percent protection rate for the Engerix-B patients

<cut>