Full Press Release Details
U.S. Federal Circuit Affirms Earlier PTAB
Decision to Invalidate All Claims of United Therapeutics Patent No. 10,716,793 ( 793 Patent)
N.C., December 20, 2023 - Liquidia Corporation (NASDAQ: LQDA) (Liquidia or the Company) announced that
the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) today affirmed the earlier decision by the Patent Trial and Appeal
Board (PTAB) which found all claims of U.S. Patent No. 10,716,793 ( 793 Patent) to be unpatentable due to the existence of
prior art cited by Liquidia in inter partes review (IPR) proceedings. As a result of today's decision, Liquidia will immediately
seek to set aside the injunction issued by the U.S. District Court for the District of Delaware (District Court) in the lawsuit filed
by United Therapeutics (UTHR) under the Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) and pursue final regulatory
approval of YUTREPIA by the U.S. Food and Drug Administration (FDA).
Roger Jeffs, Chief Executive Officer of Liquidia, stated: "We
are thrilled with the court's swift decision. We now have rulings from the Federal Circuit confirming that YUTREPIA does not infringe
any valid claim in any of the three patents that were initially asserted by United Therapeutics. We will now direct our attention towards
the more important goal of improving patients' lives and addressing unmet needs by seeking final FDA approval of YUTREPIA to treat
PAH and, subsequently, PH-ILD."
As a result of today's decision, Liquidia will also seek to dismiss
all claims related to the 793 patent in the second Hatch-Waxman lawsuit filed by UTHR in association with Liquidia's amended
New Drug Application (NDA) to add the indication to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD) to
the YUTREPIA label. On November 30, 2023, UTHR filed an amended complaint in Hatch-Waxman litigation adding allegations that the
Company infringes a newly issued patent, U.S. Patent No. 11,826,327 ('327 Patent). Because neither the '793 Patent nor
the '327 Patent was issued prior to the filing of the original NDA for YUTREPIA, the Company believes UTHR is not entitled to a
statutory 30-month stay with respect to either of these patents. The Company intends to vigorously defend itself against these allegations,
so that patients suffering from PAH and PH-ILD can have the potential to access the Company's products.
The FDA tentatively approved YUTREPIA to treat pulmonary arterial hypertension
(PAH) in November 2021. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of January 24, 2024, for the PH-ILD
About YUTREPIA (treprostinil) inhalation
YUTREPIA is an investigational, inhaled dry
powder formulation of treprostinil delivered through a convenient, low-resistance, palm-sized device. On November 5, 2021, the FDA
issued a tentative approval for YUTREPIA 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. In July 2023, Liquidia filed an amendment
to its NDA for YUTREPIA, seeking to add pulmonary hypertension with interstitial lung disease (PH-ILD) to the label. The FDA has set a
Prescription Drug User Fee Act (PDUFA) goal date of January 24, 2024 for the amendment. Previously, the FDA has confirmed that YUTREPIA
may add the treatment of PH-ILD to the label for YUTREPIA without additional clinical studies. 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 was previously referred to as LIQ861 in investigational studies.
About pulmonary arterial hypertension (PAH)
Pulmonary arterial hypertension (PAH) is a
rare, chronic, progressive disease caused by hardening and narrowing of the pulmonary arteries that can lead to right heart failure and
eventually death. Currently, an estimated 45,000 patients are diagnosed and treated in the United States. There is currently no cure for
PAH, so the goals of existing treatments are to alleviate symptoms, maintain or improve functional class, delay disease progression, and
improve quality of life.
About pulmonary hypertension associated
with interstitial lung disease (PH-ILD)
Pulmonary hypertension (PH) associated with
interstitial lung disease (ILD) includes a diverse collection of up to 150 different pulmonary diseases, including interstitial pulmonary
fibrosis, chronic hypersensitivity pneumonitis, connective tissue disease related ILD, and chronic pulmonary fibrosis with emphysema (CPFE)
among others. Any level of PH in ILD patients is associated with poor 3-year survival. A current estimate of PH-ILD prevalence in the
United States is greater than 60,000 patients, though population growth in many of these underlying ILD diseases is not yet known due
to factors including underdiagnosis and lack of approved treatments until March 2021, when inhaled treprostinil was first approved
for this indication.
About Liquidia Corporation
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) and pulmonary hypertension associated with interstitial lung disease (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 the commercialization for 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 or inter partes review proceedings
conducted at the PTAB, including 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 the PTAB with respect to the '793 patent is not determinative
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Chief Business Officer