Biota Provides Update on BARDA Contract for Laninamivir Octanoate
May 08 2014 - 7:00AM
Biota Pharmaceuticals, Inc. (Nasdaq:BOTA) (the "Company") today
announced that last night it received notice from the Department of
Health and Human Services Office of Assistant Secretary for
Preparedness and Response (ASPR) Biomedical Advanced Research and
Development Authority (BARDA), advising the Company of its decision
to terminate its contract, which was supporting the development of
laninamivir octanoate, for the convenience of the Government. The
decision is a result of a recently concluded In-Process Review. No
reasons for the termination for convenience were provided to the
Company. The Company intends to immediately begin negotiating a
final termination settlement with ASPR/BARDA with respect to the
termination of the contract.
The Company is developing laninamivir octanoate, a long-acting
neuraminidase inhibitor, administered by inhalation via the
TwinCaps® dry powder inhaler, for the treatment of influenza A and
B under an Investigational New Drug (IND) in the United States.
Laninamivir octanoate (Inavir®) has been successfully developed in
Japan by the Company's partner, Daiichi-Sankyo, where it was
approved for the treatment and prevention of influenza A and B in
2010 and 2013, respectively. Since its launch in 2010, Inavir® has
become the leading antiviral used to treat influenza in Japan.
Since the initiation of the contract with BARDA in April 2011,
the Company has advanced the development of laninamivir octanoate
under its IND as follows:
- completed three Phase 1 clinical trials (ADME, Safety and
Pharmacokinetics in Chronic Asthma Patients, and TQT);
- completed the targeted enrollment in its Phase 2 IGLOO trial on
a timely-basis, the top-line results of which are anticipated in
the third quarter of 2014;
- initiated enrollment in a Phase 1/2 trial in pediatric
patients;
- successfully completed required improvements to the TwinCaps®
dry powder inhaler; and
- made significant advancements in the process development and
manufacturing facets of the program, such that the installation of
a commercial scale filling and finishing line for the manufacture
of TwinCaps® inhaler for laninamivir octanoate can be
initiated.
"Given the commercial success of Inavir® in Japan over the past
several years, the status of the program and with top-line data
from the Phase 2 IGLOO trial anticipated in a matter of months, we
are somewhat perplexed by this decision," stated Russell H. Plumb,
President and CEO of Biota Pharmaceuticals, Inc. "Notwithstanding
this action, we intend to complete the collection, analysis, and
reporting of the data from the IGLOO trial, as well as the recently
completed Phase 1 trials. Subject to the results of IGLOO trial,
which we expect will be available in the third quarter, we will
make a data-driven decision as to the next steps in the development
of laninamivir octanoate."
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 under an IND in
the United States; 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. Any
statements that are not historical facts may be deemed to be
forward-looking statements, including statements related to the
anticipated time in which top-line results of the Phase 2 IGLOO
trial may be available, when a data-driven decision about the
Company's next steps in the development of laninamivir octanoate
may be made, or the Company's intent to negotiate final settlement
terms with ASPR/BARDA. 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, 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; the Company's ability to maintain or
obtain the necessary financial resources to continue to develop
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.,
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
Lee M. Stern
The Trout Group
(646) 378-2922
lstern@troutgroup.com
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