BERKELEY, Calif. (
) -- The U.S. Food and Drug Administration rejected
(DVAX - Get Report)
hepatitis B vaccine Heplisav, citing the need for additional safety data in healthy adults.
Dynavax shares fell 37% to $1.88 in Monday's pre-market session because that's what happens to companies who fail to get their first product to market on time. The stock closed Friday at $2.97
How long Dynavax will need to wait before re-filing Heplisav isn't clear but the company may not be delayed too long if it decides to seek approval first in a sicker patient population. "The Agency indicated its willingness to continue discussions regarding a more restricted use of Heplisav," Dynavax said in its Monday statement.
That restricted patient population could be people with chronic kidney disease. Dynavax was already planning to submit additional Heplisav data on this patient population as a post-approval supplement.
Dynavax might be able to re-file Heplisav in chronic kidney disease patients by the middle of this year, with approval and commercial launch in the middle of 2014, said Jefferies analyst Thomas Wei in a research note issued last Thursday. A broader label for Heplisav could be approved in 2015, he added.
Dynavax plans to meet with FDA within six weeks to discuss options.
In rejected Heplisav, FDA concurred with the recommendation of an advisory panel, which voted against the vaccine because of concerns about the lack of safety data in a broad population of healthy adults aged 18-70.
The FDA's rejection letter also asked Dynavax to provide additional information related to Heplisav's manufacturing.
"We had the chance to speak with the company, and it noted that there are essentially two options at the moment 1) run an additional safety study in patients aged 18-70 years, or 2) move forward with a more restrictive label (CKD or >40 years of age)," writes J.P. Morgan analyst Geoff Meacham in a research note issued Monday morning. "Of note, the request for manufacturing data comes as somewhat of a surprise, but the company is confident it can provide the requested information."
-- Reported by Adam Feuerstein in Boston.