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 indication.
About YUTREPIA™(treprostinil) inhalation
powder
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 naïve 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
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. 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
Corporation.
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 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 of the outcome of the appeal
of the decision. 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 Information
Media & Investors:Jason AdairChief Business
Officer919.328.4400jason.adair@liquidia.com
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