Biota Initiates Phase 2 Trial of Laninamivir Octanoate for the Treatment of Influenza in Adults

Biota Initiates Phase 2 Trial of Laninamivir Octanoate for the Treatment of
Influenza in Adults

ATLANTA, June 11, 2013 (GLOBE NEWSWIRE) -- Biota Pharmaceuticals, Inc.
(Nasdaq:BOTA) (the "Company") today announced that it has commenced dosing in
a multi-national, randomized, double blind, placebo controlled, parallel arm
Phase 2 clinical trial of laninamivir octanoate, a long-acting neuraminidase
inhibitor. The trial, referred to as "IGLOO", will compare the safety and
efficacy of 40 mg and 80 mg of laninamivir octanoate with placebo, all
delivered by a TwinCaps^® inhaler in adults with symptomatic influenza A or B
infection. The trial is designed to enroll 636 subjects, randomized equally
across the three treatment arms, with the primary end point being the time to
alleviation of influenza symptoms. Secondary end points include whether the
use of laninamivir octanoate reduces the incidence of secondary bacterial
infections compared to placebo. The Company's goal is to have top-line data
from this trial available in mid-2014.

IGLOO is being conducted under the Company's contract with the U.S. Office of
Biomedical Advanced Research and Development Authority ("BARDA").Further
details regarding the design of IGLOO are available at www.clinicaltrials.gov.

"The initiation of this robust, multi-center Phase 2 trial for the treatment
of influenza is an important milestone in the clinical development of
laninamivir octanoate," stated Dr. John Lambert, the Company's Vice President
of Product Development. "We believe that the potential for once-only inhaled
dosing of laninamivir octanoate could represent a significant advantage over
the five-day, twice-daily dosing associated with the currently marketed
neuraminidase inhibitors to treat influenza."

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 in development: laninamivir
octanoate, which it is developing under an existing contract with BARDA that
is intended to provide up to $231 million in financial support for the Company
to complete the clinical development of laninamivir octanoate for the
treatment of influenza A and B infections in the U.S.; and vapendavir, a
potent, oral broad-spectrum capsid inhibitor of human rhinovirus. In addition
to these clinical-stage programs, the Company has preclinical programs focused
on developing treatments for respiratory syncytial virus and gram-negative and
multi-drug resistant bacterial infections. The Company has a world-wide
license from Daiichi Sankyo Company, Ltd to develop and commercialize a number
of long-acting neuraminidase inhibitors, including laninamivir octanoate,
which is marketed by Daiichi Sankyo in Japan as Inavir^®.The Company receives
a royalty on net sales of Inavir^® in Japan, as well as on global net sales of
Relenza^®, a first-generation neuraminidase inhibitor marketed by
GlaxoSmithKline. 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. All statements, other than historical facts,
including statements regarding the Company's goal to have top-line data from
the IGLOO trial available in mid-2014, the potential for once-only dosing of
laninamivir octanoate and the amount of financial support the BARDA contract
may provide, are forward looking statements. Various important factors could
cause actual results, performance, events or achievements to materially differ
from those expressed or implied by the forward-looking statements, including
the Company, BARDA, the FDA, 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; the Company's ability to
comply with extensive government regulations in various countries and regions
in which it expects to conduct its clinical trials; the Company's inability 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; the Company's inability to
recruit and enroll a sufficient number of qualified influenza patients in its
IGLOO trial during the upcoming influenza seasons in the Northern and Southern
Hemispheres; BARDA not terminating or significantly amending the Company's
existing contract to develop laninamivir octanoate; and other cautionary
statements contained in the Company's Quarterly Reports on Form 10-Q for the
quarters ended December 31, 2012 and March 31, 2013, as filed with the U.S.
Securities and Exchange Commission, or SEC, on February 11, 2013 and May 10,
2013, respectively.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 Holdings Limited. Relenza^® is a
trademark of GlaxoSmithKline, Inavir^® is a registered trademark of Daiichi
Sankyo Company, Ltd and TwinCaps^® is a registered trademark of Hovione
FarmaCiencia SA.

CONTACT: Russell H. Plumb
         Chief Executive Officer
         (678) 221-3351
         r.plumb@biotapharma.com
        
         Hershel Berry
         Blueprint Life Science Group
         (415) 375-3340
         hberry@bplifescience.com

Biota Pharmaceuticals, Inc
 
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