Liquidia Technologies, Inc. (NASDAQ: LQDA), a late-stage clinical
biopharmaceutical company focused on the development and
commercialization of novel products using its proprietary
PRINT® technology, today announced that the U.S. Patent Trial
and Appeal Board (PTAB) has instituted inter partes review (IPR)
against U.S. Patent No. 9,604,901 (‘901) and concurrently denied
institution on 9,593,066 (‘066), both owned by United Therapeutics
Corporation (UTC) and listed in the Orange Book for Tyvaso®
(treprostinil).
For ‘901, the PTAB Institution Decision states that “based on
the information presented, we institute an inter partes review of
claims 1–9 of the ’901 patent.”
Conversely, for ‘066, the PTAB denied institution of IPR stating
that the petition “has not established a reasonable likelihood that
it would prevail in showing that at least one of the challenged
claims is unpatentable.”
“The PTAB’s decision to institute an IPR proceeding against the
‘901 patent for Tyvaso is another important step forward for
Liquidia’s ongoing effort to bring LIQ861, a convenient and well
tolerated treatment option, to the PAH community,” stated Neal
Fowler, Chief Executive Officer at Liquidia. “We believe PTAB’s
decision on ‘066 to be in error and while there are options for
reconsideration, we remain confident in the arguments of
non-infringement and invalidity to be made in district court.”
Mr. Fowler added, “The Liquidia management team and our board
are committed to providing PAH patients with alternative treatment
options, like LIQ861, that we believe they need and deserve. We
will not be deterred by any effort to limit our ability to deliver
on this goal for patients and are confident in our options to bring
LIQ861 to commercialization.”
Liquidia’s 505(b)(2) New Drug Application (NDA) for LIQ861, a
dry powder inhalation of treprostinil, is currently under active
review by the U.S. Food and Drug Administration (FDA) for the
treatment of pulmonary arterial hypertension (PAH). Tyvaso®, a
nebulized treprostinil solution, is the Reference Listed Drug for
the LIQ861 NDA.
On June 4th, UTC filed a lawsuit against Liquidia under the
Hatch-Waxman Act, based on the LIQ861 NDA, for infringement of
Tyvaso patents that triggered a 30-month stay on an FDA regulatory
approval. The 30-month stay expires on the earlier of October 24,
2022 or resolution of the litigation, whichever occurs first.
In July, UTC filed an amended complaint asserting infringement
of an additional recently issued U.S. Patent No. 10,716,793 (‘793).
Although UTC’s amended complaint brings the ‘793 patent into the
pending lawsuit, the statutory 30-month stay on regulatory
approval, is not associated with the allegations of infringement of
the ‘793 patent and the allegations of infringement of this patent
should have no effect on the FDA’s review of the LIQ861 NDA.
About LiquidiaLiquidia 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
Statements
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 timelines, including
potential U.S. Food and Drug Administration (FDA)
approval of the New Drug Application (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
two petitions for inter partes review with the Patent
Trial and Appeal Board, 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
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 and Liquidia Corporation’s filings with
the Securities and Exchange Commission, including the risk
that our proposed acquisition of RareGen, LLC is not
consummated or that the expected benefits and synergies from the
proposed acquisition are not realized, 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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