Stop-Work Order Received Pending In Process Review Decision From BARDA -
- Phase 2 IGLOO Top-Line Data Anticipated in Q3 2014 -
ATLANTA, April 29, 2014 (GLOBE NEWSWIRE) -- Biota Pharmaceuticals, Inc. (Nasdaq:BOTA)
( the "Company") today announced that it has been notified by the U.S.
Department of Health and Human Services (HHS) office of the Assistant
Secretary for Preparedness and Response (ASPR) and Biomedical Advanced
Research and Development Authority (BARDA) that pending a decision
regarding the outcome of a recently completed In Process Review (IPR) of
the Company's contract for the development of laninamivir octanoate,
ASPR/BARDA has issued a Stop-Work Order notifying the Company to
discontinue work on a number of activities under its contract.
The Company's contract provides that ASPR/BARDA will conduct IPRs in
its discretion during the performance period to discuss the progression
of milestones and deliverables under the contract. The IPR, which was
the first such review of the Company's progress since the inception of
its contract in March 2011, was conducted by a team of representatives
from the Public Health Emergency Medical Countermeasures Enterprise
(PHEMCE), which is led by ASPR, and in addition to BARDA, includes three
primary HHS internal agency partners; the Centers for Disease Control
and Prevention (CDC), the Food and Drug Administration (FDA) and the
National Institutes of Health (NIH).
As a result of the receipt of the Stop-Work Order and exceeding the
original recruitment target of 636 patients in its Phase 2 IGLOO trial,
the Company has concluded enrollment in the Northern Hemisphere and will
not enroll patients in this trial during the upcoming Southern
Hemisphere influenza season. As previously disclosed by the Company,
virology data available to-date indicate approximately 40% of the
patients enrolled in the trial had laboratory confirmed influenza A or
B. The Company anticipates that top-line results from this trial will be
available in the third quarter of 2014.
"We are surprised by this Stop-Work Order and unfortunately, do not
have any additional visibility or understanding at this time as to the
nature of ASPR/BARDA's pending decision related to the IPR," stated
Russell H. Plumb, President and CEO of Biota Pharmaceuticals, Inc. "We
anticipate that this decision will be forthcoming shortly, and we will
provide a further update at that time. In the interim, we are complying
with the order and focusing our efforts on critical path activities for
the program not covered by the order, namely completing the conduct of
and finalizing the data from our Phase 2 IGLOO trial."
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