Liquidia Receives Complete Response Letter from FDA for LIQ861 (treprostinil) Inhalation Powder for the Treatment of Pulmonar...
November 25 2020 - 7:00AM
Liquidia Technologies, Inc., a wholly owned subsidiary of Liquidia
Corporation (NASDAQ: LQDA), today announced that the U.S. Food and
Drug Administration (FDA) has issued a complete response letter
(CRL) for the company’s New Drug Application (NDA) for LIQ861
(treprostinil) inhalation powder for the treatment of pulmonary
arterial hypertension (PAH).
In the CRL, the FDA stated that it is unable to approve the NDA
at this time. The CRL identified the need for additional
information and clarification on chemistry, manufacturing and
controls (CMC) data pertaining to the drug product and device
biocompatibility. Liquidia does not believe that the items raised
in the CRL will be a barrier to the ultimate approval of
LIQ861.
The FDA also reconfirmed the need to conduct on-site
pre-approval inspections (PAIs) of two of Liquidia’s U.S.
manufacturing facilities before the application can be approved.
The FDA noted it had been unable to conduct these inspections
during the initial review cycle due to COVID-19 related travel
restrictions.
The CRL did not cite the need to conduct further clinical
studies, nor did the FDA require additional studies related to
toxicology or clinical pharmacology. Of note, Liquidia believes
that it can address the items raised in the CRL without delaying
the otherwise projected launch timing of LIQ861 in the second half
of 2022, subject to FDA approval.
“We remain very confident in LIQ861 and are committed to working
closely with the FDA to address these items to support its
approval,” said Neal Fowler, Chief Executive Officer at Liquidia.
“With more than 70 patients now having received LIQ861 for more
than two years in our clinical trials, Liquidia remains committed
to PAH patients who we believe are underserved with currently
available treatment options.”
Webcast and Conference CallLiquidia will host a
webcast and conference call Wednesday, November 25,
2020 at 9:00 a.m. ET to discuss this regulatory update for
LIQ861. The live call may be accessed by dialing 1-877-707-8711
(domestic) or 1-857-270-6219 (international) and entering the
conference code: 3295968. A live and archived webcast of the call
will also be available on the Events &
Presentations page of the Liquidia website.
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 (“DPI”)
for the treatment of pulmonary arterial hypertension
(PAH). PRINT® technology enables development of drug particles
that are precise and uniform in size, shape, weight and composition
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 PAHPAH is a chronic, progressive disease
caused by the hardening and narrowing of the pulmonary arteries
that can lead to right heart failure and eventually death.
Treprostinil is a synthetic analog of prostacyclin, a vasoactive
mediator essential to normal lung function that is deficient in
patients with PAH. PAH is a rare disease, with an estimated
prevalence in the United States of approximately 30,000 patients.
The exact cause of PAH is often unknown and, although the symptoms
are treatable, there is no known cure for the disease.
About LiquidiaLiquidia Technologies, Inc.,
a wholly owned subsidiary of Liquidia Corporation, is a
late-stage clinical biopharmaceutical company focused on the
development and commercialization of novel products using its
proprietary PRINT® technology to transform the lives of patients.
PRINT is a particle engineering platform that enables precise
production of uniform drug particles designed to improve the
safety, efficacy and performance of a wide range of therapies.
Currently, Liquidia is focused on the development of two
product candidates for which it holds worldwide commercial rights:
LIQ861 for the treatment of pulmonary arterial hypertension (PAH)
and LIQ865 for the treatment of local post-operative
pain. Liquidia is headquartered in Research Triangle
Park, NC. 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 anticipated submission
contents and timelines, including potential resubmission of
the NDA following our receipt of a CRL 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
its inter partes review with the Patent Trial and Appeal
Board (PTAB), the issuance of patents by the U.S. Patent and
Trademark Office (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 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 Liquidia’s 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:Michael ParksCorporate
Communications484.356.7105michael.parks@liquidia.com
Investors:Jason AdairVice President, Corporate
Development and Strategy919.328.4400jason.adair@liquidia.com
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