Full Press Release Details
District Court Issues Favorable
Ruling and Denies United Therapeutics' Request to Block YUTREPIA Launch
MORRISVILLE, N.C., June 3,
2024 - Liquidia Corporation (NASDAQ: LQDA) announced today that on May 31, Judge Andrews of the U.S. District
Court for the District of Delaware (District Court) denied the motion for preliminary injunction filed by United Therapeutics (UTHR) that
sought to block the launch of Liquidia's YUTREPIA (treprostinil) inhalation powder to treat pulmonary hypertension associated
with interstitial lung disease (PH-ILD). The ruling reinforces the clear path for the U.S. Food and Drug Administration (FDA) to issue
a final decision on the amended New Drug Application (NDA) for YUTREPIA.
Dr. Roger Jeffs, Chief Executive
Officer of Liquidia, said: "We are pleased that Judge Andrews ruled that United Therapeutics' request for an injunction
failed on critical grounds, including UTHR's failure to show our obviousness challenge lacks substantial merit and
UTHR's failure to show that the public interest weighs in favor of an injunction. While we await a final FDA action, we will
continue to intensify our commercial preparations as we work to make this important treatment option available to pulmonary arterial
hypertension (PAH) and PH-ILD patients."
The motion for preliminary injunction was filed in the lawsuit (Case
No. 23-975) filed by UTHR in September 2023 in which it has alleged YUTREPIA would infringe U.S. Patent No. 11,826,327
( 327 patent). While this ruling maintains the status quo in which there is no legal impediment to the FDA granting final approval
to YUTREPIA, this lawsuit will continue forward to trial, which is currently scheduled for June 2025.
Friday's ruling follows earlier legal rulings from multiple
bodies finding that YUTREPIA does not infringe any valid claim of the patents previously asserted by UTHR, including the decision by the
Patent Trial and Appeal Board, affirmed by the U.S. Court of Appeals for the Federal Circuit (Federal Circuit), that all claims of U.S.
Patent No. 10,716,793 ( 793 Patent) to be unpatentable. UTHR has stated that it plans to appeal the Federal Circuit's
affirmation of the invalidity of the 793 Patent to the United States Supreme Court. Separately, UTHR has also appealed Judge Andrews'
ruling to set aside an injunction that he had previously issued blocking the launch of YUTREPIA based solely on the 793 Patent.
(treprostinil) inhalation powder
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
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
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. Similarly, favorable decisions
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Chief Business Officer
Director, Corporate Communications