Biota Receives FDA Fast Track Designation for Its Antiviral BTA585 for the Treatment of Respiratory Syncytial Virus Infection...
February 16 2016 - 9:00AM
Biota Pharmaceuticals, Inc. (NASDAQ:BOTA), a biopharmaceutical
company focused on the discovery and development of direct-acting
antivirals that address infections that have limited therapeutic
options, announced today that the U.S. Food and Drug Administration
(FDA) granted Fast Track designation to its antiviral compound,
BTA585, for the treatment of respiratory syncytial virus (RSV)
infections in infants, young children and adults. The FDA Fast
Track process is designed to expedite the development and review of
drugs used in the treatment of serious or life-threatening
conditions and which demonstrate potential to address unmet medical
needs.
“There are no direct antiviral products approved to treat the
millions of RSV infections that occur each year in the U.S. and we
are pleased that the FDA has recognized BTA585 and its potential to
address this significant unmet medical need,” remarked Joseph
Patti, PhD, president and chief executive officer at Biota. “Fast
Track designation is another positive step for BTA585 and its
development for the treatment of respiratory infections in children
and adults.”
BTA585 is an oral RSV fusion inhibitor in development for the
treatment and prevention of RSV infections. BTA585 has successfully
completed a Phase 1 single ascending dose trial and has recently
completed dosing in a multiple ascending dose trial with results
expected to be reported this quarter. A Phase 2 RSV challenge trial
is expected to begin in the second quarter of 2016.
About Respiratory Syncytial Virus (RSV)
RSV is a major cause of acute upper (colds) and lower (pneumonia
and bronchiolitis) respiratory tract infections in infants, young
children, and adults. Each year in the United States, RSV accounts
for an estimated 2.1 million medical visits in children under the
age of five, with many of the children afflicted requiring
hospitalization.
About Biota Pharmaceuticals, Inc.
Biota Pharmaceuticals is focused on the
discovery and development of direct-acting antivirals to treat
infections that have limited therapeutic options and affect a
significant number of patients globally. The Company has three
product candidates in active clinical development. These include:
vapendavir, an oral treatment for human rhinovirus infections in
moderate-to-severe asthmatics, currently being evaluated in the
Company’s ongoing Phase 2b SPIRITUS trial; BTA585, an oral fusion
protein inhibitor in Phase 1 development for the treatment and
prevention of respiratory syncytial virus infections; and BTA074, a
topical antiviral treatment in Phase 2 development for condyloma
caused by human papillomavirus types 6 & 11. For additional
information about the Company, please visit
www.biotapharma.com.
Forward-Looking Statements
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
Biota’s business, operations and financial performance. Any
statements that are not of historical facts may be deemed to be
forward-looking statements, including the potential efficacy of the
Company’s three programs in the clinic. 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, the U.S. Food
and Drug Administration (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 any of the Company's
product candidates at any time for a lack of safety, tolerability,
regulatory or manufacturing issues, or any other reason whatsoever;
the Company's ability to secure, manage and retain qualified
third-party clinical research data management and contract
manufacturing organizations upon which it relies to assist in the
design, development, implementation and execution of the clinical
development of all its product candidates and those organizations
ability to successfully execute their contracted responsibilities;
the Company’s ability to comply with applicable government
regulations in various countries and regions in which we are
conducting, or expect to conduct, clinical trials; and other
cautionary statements contained elsewhere in this press release and
in our Annual Report on Form 10-K, Quarterly Report on Form 10-Q
and our other reports filed with the Securities and Exchange
Commission. 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.
Contacts:
Mark Colonnese
Executive Vice President and Chief Financial Officer
Biota Pharmaceuticals, Inc.
(678) 221-3352
m.colonnese@biotapharma.com
Beth DelGiacco
Stern Investor Relations, Inc.
(212) 362-1200
beth@sternir.com
Vaxart (NASDAQ:VXRT)
Historical Stock Chart
From Mar 2024 to Apr 2024
Vaxart (NASDAQ:VXRT)
Historical Stock Chart
From Apr 2023 to Apr 2024