FDA Completes On-site Pre-Approval Inspection of Liquidia’s Morrisville, North Carolina Facility
August 18 2021 - 4:15PM
Liquidia Corporation (NASDAQ: LQDA) announced today that the U.S.
Food and Drug Administration (FDA) has completed an on-site
Pre-Approval Inspection (PAI) of its Morrisville, North Carolina
facility in connection with the on-going review of the New Drug
Application (NDA) for LIQ861 (treprostinil) inhalation powder. The
5-day PAI concluded on August 13 and no Form 483 Inspectional
Observations were issued. This was Liquidia’s first inspection of
the Morrisville site by the FDA.
Robert Lippe, Chief Operations Officer at Liquidia, stated:
“This is a very important element in our advancement of LIQ861
through the NDA process. In addition, we believe this favorable
outcome from the first FDA inspection of our proprietary PRINT®
technology helps demonstrate the potential for future applications
of our precise, uniform drug particles across different types of
molecules, therapeutic areas and routes of administration.”
Damian deGoa, Chief Executive Officer at Liquidia, added: “We
are pleased that it was possible to complete this inspection
despite the challenges presented by the on-going COVID-19 pandemic.
As a company, we will continue to build on the momentum of the
completion of the PAI, alongside our successes in on-going
litigation against United Therapeutics and the strong launch of our
subcutaneous administration of Treprostinil Injection.”
On June 2, 2021, the FDA accepted for review the NDA
resubmission for LIQ861 (treprostinil) inhalation powder and under
the Prescription Drug User Fee Act (PDUFA) set a goal date of
November 7, 2021. The resubmitted NDA included additional
information and clarification on chemistry, manufacturing, and
controls (CMC) pertaining to the drug product as well as data on
device biocompatibility. No additional data from clinical trials or
studies related to toxicology or clinical pharmacology were
required. The NDA has been submitted under the 505(b)(2) regulatory
pathway and Tyvaso®, a nebulized treprostinil solution, is the
Reference Listed Drug for the LIQ861 NDA.
In July 2021, the Company received a notice from the FDA that,
due to restrictions on travel related to COVID-19, the FDA may be
unable to conduct pre-approval inspections prior to the PDUFA goal
date. On August 6, 2021, the FDA notified Liquidia of the planned
PAI of the Morrisville site beginning on August 9, 2021, which was
concluded on August 13, 2021. In addition to the completed
inspection of Liquidia’s Morrisville site, the FDA has notified
Liquidia that a PAI will also be required for the third-party
provider of encapsulation and packaging services for LIQ861. At
this time, the Company has not been notified of when this
additional PAI may be completed.
About LIQ861LIQ861 is an investigational
inhaled dry powder formulation of treprostinil designed using
Liquidia’s PRINT® technology with the goal of enhancing deep-lung
delivery using a convenient, palm-sized dry powder inhaler for the
treatment of pulmonary arterial hypertension (PAH). PRINT®
technology 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 believes LIQ861 can overcome the limitations
of current inhaled therapies and has the potential to maximize the
therapeutic benefits of treprostinil in treating PAH by safely
delivering higher doses into the lungs. Liquidia has completed an
open-label, multi-center phase 3 clinical study of LIQ861 in
patients diagnosed with PAH known as INSPIRE, or Investigation of
the Safety and Pharmacology of Dry Powder Inhalation of
Treprostinil.
About Treprostinil InjectionTreprostinil
Injection is the first-to-file, fully substitutable generic
treprostinil for parenteral administration. Treprostinil Injection
contains the same active ingredient, same strengths, same dosage
form and same inactive ingredients as Remodulin® (treprostinil),
and is offered to patients and physicians with the same level of
service and support, but at a lower price than the branded drug.
Liquidia PAH promotes the appropriate use of Treprostinil Injection
for the treatment of PAH in the United States in partnership with
its commercial partner, who holds the Abbreviated New Drug
Application (ANDA) with the FDA.
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 is developing LIQ861, an inhaled dry powder
formulation of treprostinil 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 our future results of operations and financial position,
our strategic and financial initiatives, our business strategy and
plans and our 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 our response to the Complete Response Letter
received in November 2020, the potential for
eventual FDA approval of the NDA for LIQ861, the timeline
or outcome related to our patent litigation pending in
the U.S. District Court for the District of Delaware or
our inter partes review with the PTAB, the issuance of
patents by the USPTO and our ability to execute on our strategic or
financial initiatives, involve significant risks and uncertainties
and actual results could differ materially from those expressed or
implied herein. The completion and outcome of the PAI are not
determinative of the ultimate decision by the FDA whether to
approve or not approve the NDA for LIQ861. 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. We have based these forward-looking
statements largely on our current expectations and projections
about future events and financial trends that we believe may affect
our 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 our filings with the SEC,
including the impact of the coronavirus (COVID-19) outbreak on our
Company and our financial condition and results of operations, as
well as a number of uncertainties and assumptions. Moreover, we
operate in a very competitive and rapidly changing environment and
our industry has inherent risks. New risks emerge from time to
time. It is not possible for our management to predict all risks,
nor can we assess the impact of all factors on our 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 we 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 we undertake no duty to update our 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
Liquidia (NASDAQ:LQDA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Liquidia (NASDAQ:LQDA)
Historical Stock Chart
From Apr 2023 to Apr 2024