Biota Provides an Update on the Development of Laninamivir Octanoate
April 30 2014 - 10:00PM
Biota Pharmaceuticals, Inc. (Nasdaq:BOTA) (the "Company") today
announced that an interim update has been provided from the U.S.
Department of Health and Human Services (HHS) and the Biomedical
Advanced Research and Development Authority (BARDA) with respect to
the Stop-Work Order the Company recently received from BARDA and
its pending decision regarding a recent In Process Review (IPR) of
its contract to support the development of laninamivir octanoate.
BARDA Director Robin Robinson, Ph.D., provided the following
update: "It is important to keep in mind that a Stop-Work Order is
not a contract termination. We have some concerns about the project
with regard to the product manufacturing, clinical study enrollment
pace, costs, and contractor performance. Since the project is at a
natural pause following the end of the flu season for the Northern
Hemisphere, we are considering what is the best next step for the
Biota project and the overall influenza antiviral drug development
program before going forward with clinical studies in the Southern
Hemisphere and manufacturing optimization and validation."
The Company has been advised by BARDA that the final decision
regarding the outcome of the IPR should be forthcoming within the
next week.
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 to complete its development
and file 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 a decision from the IPR should be
forthcoming. 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 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.
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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