WARRINGTON, Pa., Feb. 16, 2021 /PRNewswire/ -- Windtree
Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology and medical
device company focused on advancing multiple late-stage
interventions for acute cardiovascular and pulmonary disorders,
today announced that the United States Patent and Trademark Office
(USPTO) has issued U.S. Patent No. 10,874,818, covering features of
the aerosol delivery system (ADS) for the Company's
AEROSURF® drug delivery device. This patent
adds to the robust patent portfolio exclusively licensed to
Windtree in the field of aerosolized delivery of pulmonary
surfactants, alone or combined with other agents.
Windtree completed design verification of the newly designed ADS
platform, which utilizes the same aerosolization technology used
during the phase 2 clinical program evaluating AEROSURF in treating
preterm infants with Respiratory Distress Syndrome (RDS), but with
improved ergonomics, interface, controls, and dose monitoring in a
modular design. The new ADS also implements design changes to
potentially mitigate the risks of device-related treatment
interruptions experienced in the prototype device used in the
AEROSURF phase 2b clinical trial. The
Company believes the redesigned device may support enhanced
clinical outcomes by potentially allowing for reduced time to
initial administration of our KL4 surfactant and reduced time
intervals between doses compared to the phase 2 prototype. This
patent protection covers device elements that will facilitate
modification for use in a wider range of patients including adults
with respiratory disease or for drug delivery.
The new U.S. Patent covers the ADS, which includes an aerosol
delivery unit, the cartridge receiver, assembly, an inductor
assembly, capillary tube, and susceptor for the delivery of aerosol
from liquid formulation. Additionally, the patent allows for the
ADS to include a power control unit and operation interface. The
patent extends the Company's device protection until 2039.
"We are pleased to strengthen our intellectual property
protection with the addition of the U.S. patent covering a key
element in our AEROSURF drug delivery device," said Craig Fraser, CEO and President. "This new
in-licensed patent expands our overall IP portfolio surrounding
AEROSURF. We are active in strengthening the global patent estate
for all of our assets and technology, not just with AEROSURF but
also with our cardiovascular portfolio including our lead asset,
istaroxime, for acute heart failure."
About Windtree Therapeutics
Windtree Therapeutics,
Inc. is advancing multiple late-stage interventions for acute
cardiovascular and pulmonary disorders to treat patients in moments
of crisis. Using new clinical approaches, Windtree is developing a
multi-asset franchise anchored around compounds with an ability to
activate SERCA2a, with lead candidate istaroxime being developed as
a first-in-class treatment for acute heart failure and early
cardiogenic shock in heart failure. Windtree has also focused on
developing AEROSURF® as a non-invasive surfactant treatment for
premature infants with respiratory distress syndrome, and is
facilitating transfer of clinical development of
AEROSURF® to its licensee in Asia, Lee's HK, while Windtree evaluates
other uses for its synthetic KL4 surfactant for the treatment of
acute pulmonary conditions including lung injury due to viral,
chemical and radiation induced insults. Also in its portfolio is
rostafuroxin, a novel precision drug product targeting hypertensive
patients with certain genetic profiles.
For more information, please visit the Company's website at
www.windtreetx.com.
Forward-Looking Statements
This press release
contains forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995. The Company may,
in some cases, use terms such as "predicts," "believes,"
"potential," "proposed," "continue," "estimates," "anticipates,"
"expects," "plans," "intends," "may," "could," "might," "will,"
"should" or other words that convey uncertainty of future events or
outcomes to identify these forward-looking statements. Such
statements are based on information available to the Company as of
the date of this press release and are subject to numerous
important factors, risks and uncertainties that may cause actual
events or results to differ materially from the Company's current
expectations. Examples of such risks and uncertainties include:
risks and uncertainties associated with the ongoing economic and
social consequences of the COVID-19 pandemic, including any adverse
impact on the Company's clinical trials or disruption in supply
chain; the success and advancement of the clinical
development programs for istaroxime, AEROSURF®, KL4 surfactant and
the Company's other product candidates; the Company's ability to
secure significant additional capital as and when needed; the
Company's ability to access the debt or equity markets; the
Company's ability to manage costs and execute on its operational
and budget plans; the results, cost and timing of the Company's
clinical development programs, including any delays to such
clinical trials relating to enrollment or site initiation; risks
related to technology transfers to contract manufacturers and
manufacturing development activities; delays encountered by the
Company, contract manufacturers or suppliers in manufacturing drug
products, drug substances, aerosol delivery systems (ADS) and other
materials on a timely basis and in sufficient amounts; risks
relating to rigorous regulatory requirements, including that: (i)
the FDA or other regulatory authorities may not agree with the
Company on matters raised during regulatory reviews, may require
significant additional activities, or may not accept or may
withhold or delay consideration of applications, or may not approve
or may limit approval of the Company's product candidates,
and (ii) changes in the national or international political and
regulatory environment may make it more difficult to gain
regulatory approvals and risks related to the Company's efforts to
maintain and protect the patents and licenses related to its
product candidates; risks related to the size and growth potential
of the markets for the Company's product candidates, and the
Company's ability to service those markets; the Company's ability
to develop sales and marketing capabilities, whether alone or with
potential future collaborators; and the rate and degree of market
acceptance of the Company's product candidates, if approved.
These and other risks are described in the Company's periodic
reports, including the annual report on Form 10-K, quarterly
reports on Form 10-Q and current reports on Form 8-K, filed with or
furnished to the Securities and Exchange Commission and available
at www.sec.gov. Any forward-looking statements that the
Company makes in this press release speak only as of the date of
this press release. The Company assumes no obligation to update
forward-looking statements whether as a result of new information,
future events or otherwise, after the date of this press
release.
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SOURCE Windtree Therapeutics, Inc.