Full Press Release Details
Favorable Legal and Regulatory Outcomes Clearing Path for Potential FDA approval of YUTREPIA (treprostinil) inhalation powder
MORRISVILLE, N.C., April 1, 2024 - Liquidia
Corporation (NASDAQ: LQDA) (Liquidia or the Company) announced today that on March 28, Judge Andrews of the U.S. District Court for
the District of Delaware (District Court) has set aside the injunction that was issued in August 2022 in the lawsuit filed by United
Therapeutics (UTHR) in Case No. 1:20-cv-00755-RGA (the Original Hatch-Waxman Litigation). As a result, the U.S. Food and Drug Administration
(FDA) is no longer enjoined from issuing final approval of Liquidia's New Drug Application (NDA) for YUTREPIA (treprostinil)
Dr. Roger Jeffs, Chief Executive Officer
of Liquidia, said: "With the recent decision by Judge Andrews, the path is cleared for us to seek final approval for YUTREPIA. We
have submitted the judge's order to the FDA and look forward to a decision from the FDA in the near future. Our commercial team
is fully prepared to launch YUTREPIA in both PAH and PH-ILD should the FDA grant final approval. Once launched, we are confident that
YUTREPIA's convenient, low-effort delivery and wide dosing range will propel the therapy towards our goal of establishing YUTREPIA
as the prostacyclin of first choice."
The FDA tentatively approved YUTREPIA to treat pulmonary arterial hypertension
(PAH) in November 2021. In July 2023, the Company amended its NDA to add the indication to treat pulmonary hypertension associated
with interstitial lung disease (PH-ILD). On March 31, 2024, the new clinical investigation exclusivity granted to Tyvaso to
treat PH-ILD expired. The FDA is now able to take final action on YUTREPIA's amended NDA that seeks approval for both indications.
United Therapeutics has filed a notice of appeal with respect to Judge
Andrews' decision to set aside the injunction. In addition, United Therapeutics has filed two separate lawsuits in which it is seeking
to obtain new injunctions to prevent launch of YUTREPIA for the treatment of PH-ILD. For both of these actions, UTHR bears the burden
of demonstrating, among other things, that it is substantially likely to succeed on the merits and that UTHR will be irreparably harmed
if the injunctions are not granted. None of these appeals or actions will impede the Company's launch of YUTREPIA unless UTHR is
successful in obtaining the relief it is seeking.
In the first action, UTHR filed a lawsuit against FDA in the U.S. District
Court for the District of Columbia (Case No. 24-484), and a motion for a temporary restraining order and preliminary injunction,
seeking to prevent FDA from approving Liquidia's amended NDA. After a hearing on March 29, Judge Bates, who is presiding over
this lawsuit, denied UTHR's motion. Specifically, the Court held that the subject of UTHR's case, FDA's acceptance of
Liquidia's amended NDA for substantive review, is not a final agency action that UTHR can challenge in court. The Court has scheduled
a status conference for April 2 to establish a process for UTHR's claims to be reevaluated after the FDA acts on the Company's
In the second action, UTHR filed a lawsuit against the Company in Delaware
District Court (Case No. 23-975) alleging that YUTREPIA would infringe U.S. Patent No. 11,826,327 ( 327 patent), which
issued in November 2023. UTHR has filed a motion for preliminary injunction to block Liquidia from launching YUTREPIA for PH-ILD.
Briefing on UTHR's motion remains in process.
About YUTREPIA (treprostinil) inhalation
YUTREPIA is an investigational, inhaled dry
powder formulation of treprostinil delivered through a convenient, low-effort, palm-sized device. The FDA previously issued tentative
approval of YUTREPIA for the PAH indication in November 2021. 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 enhanced 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 na ve to inhaled treprostinil or who are transitioning from Tyvaso (nebulized treprostinil). YUTREPIA is currently being
studied in the ASCENT trial, an Open-Label Prospective Multicenter Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil
in Pulmonary Hypertension, with the objective of informing YUTREPIA's dosing and tolerability profile in patients with PH-ILD. YUTREPIA
was previously referred to as LIQ861 in investigational studies.
About Liquidia Corporation
Liquidia 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. (Liquidia Technologies)
and Liquidia PAH, LLC (Liquidia PAH). Liquidia Technologies has developed YUTREPIA (treprostinil) inhalation powder for the treatment
of PAH and PH-ILD. Liquidia Technologies is also developing L606, an investigational liposomal formulation of treprostinil administered
twice-daily with a short-duration next-generation nebulizer, for use in North America. Liquidia PAH provides for the commercialization
of pharmaceutical products to treat pulmonary disease, such as generic Treprostinil Injection. For more information, please visit www.liquidia.com.
Tyvaso is a registered trademark
of United Therapeutics.
Cautionary Statements Regarding Forward-Looking
This 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 the potential for final FDA approval of the NDA for YUTREPIA, the timeline or
outcome related to patent litigation in the U.S. District Court for the District of Delaware, inter partes review proceedings conducted
at the PTAB or other litigation instituted by United Therapeutics or others, including rehearings or appeals of decisions in any such
proceedings, 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 favorable decisions of
courts or other tribunals are not determinative of the outcome of the appeals or rehearings of the decisions. 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, 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.
Chief Business Officer