Biota Reports That Laninamivir Octanoate is Approved for the Prevention of Influenza in Japan
December 20 2013 - 4:49PM
Biota Pharmaceuticals, Inc. (Nasdaq:BOTA) ("Biota" or the
"Company") today reported that Daiichi Sankyo Company, Limited
("Daiichi Sankyo") has been granted regulatory approval in Japan to
manufacture and market Inavir® Dry Powder Inhaler 20mg (generic
name laninamivir octanoate) for the prevention of influenza A and
B. Inavir® was successfully developed and launched by Daiichi
Sankyo in Japan for treatment of influenza A and B viruses in
October, 2010. Biota is developing laninamivir octanoate outside of
Japan for the treatment of influenza, and is currently conducting a
large, multi-national Phase 2 trial of laninamivir octanoate in
adults infected with influenza. In 2003, the Company and Daiichi
Sankyo entered into a collaboration and license agreement to
develop long-acting neuraminidase inhibitors, including laninamivir
octanoate, and in March 2009, the parties entered into a
commercialization agreement, pursuant to which Daiichi Sankyo
obtained exclusive marketing rights to laninamivir octanoate in
Japan.
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, (LANI), a
long-acting neuraminidase inhibitor that the Company is developing
for the treatment of influenza A and B infections under an IND in
the United States through a contract with the U.S. Office of
Biomedical Advanced Research and Development Authority (BARDA) that
is designed to provide up to $231 million in financial support to
complete its clinical development; and vapendavir, a potent, oral
broad spectrum capsid inhibitor of enteroviruses, including human
rhinovirus (HRV). In addition to these clinical-stage programs, the
Company has a preclinical program focused on developing treatments
for respiratory syncytial virus (RSV). 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 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
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 in the Company's
Quarterly Report on Form 10-Q for the quarters ended September 30,
2013, as filed with the SEC on November 12, 2013.
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 and
Inavir® is a registered trademark of Daiichi Sankyo Company,
Limited.
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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