Liquidia Corporation (NASDAQ: LQDA) announced today that the U.S.
Food and Drug Administration (FDA) granted tentative approval for
YUTREPIA™ (treprostinil) inhalation powder, previously referred to
as LIQ861. YUTREPIA is indicated for the treatment of pulmonary
arterial hypertension (PAH) to improve exercise ability in adult
patients with New York Heart Association (NYHA) Functional Class
II-III symptoms. Tentative approval indicates that YUTREPIA has met
all regulatory standards for quality, safety and efficacy required
for approval in the United States.
Dr. Tushar Shah, Chief Medical Officer of Liquidia, said: “We
would like to take the opportunity to thank the patients and
investigators who participated in the clinical development of
YUTREPIA. The tentative approval for YUTREPIA is another step
toward providing an important option for patients with PAH in the
U.S. We believe YUTREPIA can improve the limitations of current
nebulized therapies by allowing the administration of an expanded
dose range of inhaled treprostinil using a proven, convenient,
palm-sized device.”
The addressable market for inhaled treprostinil is significant
and expected to grow. In 2020, United Therapeutics reported that
its nebulized formulation of treprostinil indicated for PAH
achieved sales of more than $480 million. The attributes of
YUTREPIA including ease-of-use, convenience, direct lung delivery,
and higher dosage range may not only make YUTREPIA a preference to
nebulized therapy, but also an alternative to oral treatments, and
possibly a treatment option to delay the use of parenteral
therapies in PAH. There may also be future expansion opportunities
for inhaled treprostinil into additional indications.
Damian deGoa, Chief Executive Officer of Liquidia added: “This
is a significant milestone for Liquidia. We are really proud of our
team. Not only does the tentative approval establish the safety and
efficacy of YUTREPIA for PAH patients but, in the process, we have
validated our proprietary PRINT® technology to engineer discrete
drug particles with uniform composition, size, and shape. There is
more work to be done. We will now focus our efforts on
pre-commercial launch activities and the growing market opportunity
for YUTREPIA in PAH and potential new indications.”
Due to a regulatory stay pursuant to the Drug Price Competition
and Patent Term Restoration Act (Hatch-Waxman Act), YUTREPIA cannot
yet be marketed in the United States. In June 2020, United
Therapeutics filed a lawsuit against Liquidia for alleged
infringement of three patents related to Tyvaso®. As a result, the
FDA cannot give final approval of YUTREPIA until the expiration of
the regulatory stay on October 27, 2022, or earlier resolution or
settlement of the ongoing litigation.
Webcast and Conference CallLiquidia will host a
webcast and conference call Monday, November 8, 2021, at 9:00 a.m.
EST to discuss this regulatory update for YUTREPIA™ (treprostinil)
inhalation powder. The live call may be accessed by dialing
1-877-707-8711 (domestic) or 1-857-270-6219 (international) and
entering the conference code: 8254404. A live and archived webcast
of the webcast will also be available on the Events &
Presentations page of the Liquidia website at
https://liquidia.com/index.php/investors/events-and-presentations.
Tyvaso® is a registered trademark of United Therapeutics.
About YUTREPIA™(treprostinil) inhalation
powderYUTREPIA is an investigational, inhaled dry powder
formulation of treprostinil delivered through a proven, convenient,
palm-sized device. On November 5, 2021, the FDA issued a tentative
approval for YUTREPIA, which is indicated for the treatment of
pulmonary arterial hypertension (PAH) to improve exercise ability
in adult patients with New York Heart Association (NYHA) Functional
Class II-III symptoms. YUTREPIA was designed using Liquidia’s
PRINT® technology, which enables the development of drug particles
that are precise and uniform in size, shape, and composition, and
that are engineered for optimal deposition in the lung following
oral inhalation. Liquidia has completed INSPIRE, or Investigation
of the Safety and Pharmacology of Dry Powder Inhalation of
Treprostinil, an open-label, multi-center phase 3 clinical study of
YUTREPIA in patients diagnosed with PAH who are naïve to inhaled
treprostinil or who are transitioning from Tyvaso (nebulized
treprostinil). YUTREPIA was previously referred to as LIQ861 in
investigational studies.
About Liquidia CorporationLiquidia
Corporation is a biopharmaceutical company focused on the
development and commercialization of products in pulmonary
hypertension and other applications of its PRINT® Technology. The
company operates through its two wholly owned subsidiaries,
Liquidia Technologies, Inc. and Liquidia PAH, LLC. Liquidia
Technologies has developed YUTREPIA™ (treprostinil) inhalation
powder for the treatment of pulmonary arterial hypertension (PAH).
Liquidia PAH provides the commercialization for rare disease
pharmaceutical products, such as generic Treprostinil Injection.
For more information, please visit www.liquidia.com.
Cautionary Statements Regarding Forward-Looking
StatementsThis press release may include forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. All statements contained in this press release
other than statements of historical facts, including statements
regarding future results of operations and financial position,
strategic and financial initiatives, business strategy and plans
and objectives for future operations, are forward-looking
statements. Such forward-looking statements, including statements
regarding clinical trials, clinical studies and other clinical work
(including the funding therefor, anticipated patient enrollment,
safety data, study data, trial outcomes, timing or associated
costs), regulatory applications and related submission contents and
timelines, including the potential for final FDA approval of the
NDA for YUTREPIA, the timeline or outcome related to Liquidia’s
patent litigation pending in the U.S. District Court for the
District of Delaware or its inter partes review with the PTAB or
any related appeals, the issuance of patents by the USPTO and
Liquidia’s ability to execute on its strategic or financial
initiatives, involve significant risks and uncertainties and actual
results could differ materially from those expressed or implied
herein. The words “anticipate,” “believe,” “continue,” “could,”
“estimate,” “expect,” “intend,” “may,” “plan,” “potential,”
“predict,” “project,” “should,” “target,” “would,” and similar
expressions are intended to identify forward-looking statements.
Liquidia has based these forward-looking statements largely on its
current expectations and projections about future events and
financial trends that it believes may affect its financial
condition, results of operations, business strategy, short-term and
long-term business operations and objectives and financial needs.
These forward-looking statements are subject to a number of risks
discussed in Liquidia’s filings with the SEC, including the impact
of the coronavirus (COVID-19) outbreak on the company and its
financial condition and results of operations, as well as a number
of uncertainties and assumptions. Moreover, Liquidia operates in a
very competitive and rapidly changing environment and its industry
has inherent risks. New risks emerge from time to time. It is not
possible for Liquidia’s management to predict all risks, nor can
Liquidia assess the impact of all factors on its business or the
extent to which any factor, or combination of factors, may cause
actual results to differ materially from those contained in any
forward-looking statements Liquidia may make. In light of these
risks, uncertainties and assumptions, the future events discussed
in this press release may not occur and actual results could differ
materially and adversely from those anticipated or implied in the
forward-looking statements. Nothing in this press release should be
regarded as a representation by any person that these goals will be
achieved, and Liquidia undertakes no duty to update its goals or to
update or alter any forward-looking statements, whether as a result
of new information, future events or otherwise.
Contact InformationMedia &
Investors:Jason AdairVice President, Corporate Development
and Strategy919.328.4400jason.adair@liquidia.com
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