Biota Provides an Update on the Development of Laninamivir Octanoate
29 April 2014 - 9:00PM
- Stop-Work Order Received Pending In
Process Review Decision From BARDA -
- Phase 2 IGLOO Top-Line Data Anticipated
in Q3 2014 -
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."
About Biota
Biota Pharmaceuticals, Inc. is a biopharmaceutical company
focused on the discovery and development of products to prevent and
treat serious and potentially life-threatening infectious diseases.
The Company currently has two Phase 2 clinical-stage product
candidates: laninamivir octanoate, which the Company is developing
for the treatment of influenza A and B infections in the United
States through a contract with BARDA that is intended to provide up
to $231 million in financial support towards the filing of a New
Drug Application (NDA); and vapendavir, a potent, oral broad
spectrum capsid inhibitor of enteroviruses, including human
rhinovirus. In addition to these clinical-stage development
programs, the Company has preclinical programs focused on
developing treatments for respiratory syncytial virus. For
additional information about the Company, please visit
www.biotapharma.com.
Safe Harbor Statement
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that involve known and unknown risks and uncertainties concerning
our business, operations and financial performance. Any statements
that are not of historical facts may be deemed to be
forward-looking statements, including statements related to the
anticipated time in which the Government will render a decision
from the IPR and the time in which top-line results of the Phase 2
IGLOO trial may be available. Various important factors could cause
actual results, performance, events or achievements to materially
differ from those expressed or implied by forward-looking
statements, including the Company, BARDA, the FDA or a similar
regulatory body in another country, a data safety monitoring board,
or an institutional review board, delaying, limiting, suspending or
terminating the clinical development of laninamivir octanoate at
any time for a lack of safety, tolerability, anti-viral activity,
commercial viability, regulatory or manufacturing issues, or any
other reason whatsoever; BARDA terminating or significantly
amending the Company's existing contract to support the development
of laninamivir octanoate; the Company's ability to secure, manage
and retain qualified third-party clinical research, preclinical
research, data management and contract manufacturing organizations
which it relies on to assist in the design, development and
implementation of the clinical development of laninamivir
octanoate, and other cautionary statements contained elsewhere in
this press release and in the Company's Annual Report on Form 10-K
for the year ended June 30, 2013, as filed with the U.S. Securities
and Exchange Commission, or SEC, on September 27, 2013 and its Form
10-Q's as filed with the SEC on November 12, 2013 and February 10,
2014.
There may be events in the future that the Company is unable to
predict, or over which it has no control, and the Company's
business, financial condition, results of operations and prospects
may change in the future. The Company may not update these
forward-looking statements more frequently than quarterly unless it
has an obligation under U.S. Federal securities laws to do so.
Biota is a registered trademark of Biota Pharmaceuticals, Inc.
TwinCaps® is a registered trademark of Hovione FarmaCiencia SA.
CONTACT: Russell H. Plumb
Chief Executive Officer
(678) 221-3351
r.plumb@biotapharma.com
Lee M. Stern
The Trout Group
(646) 378-2922
lstern@troutgroup.com
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