Full Press Release Details
Liquidia and GSK Restructure License to
PRINT Technology for Inhaled Applications
N.C., April 3, 2023 - Liquidia Corporation (NASDAQ: LQDA) (Liquidia or the Company) announced today that
it has entered a new, non-exclusive license agreement with GSK to enable pre-clinical research of inhaled formulations of GSK's
molecules based upon Liquidia's proprietary PRINT technology. This agreement supersedes the collaboration agreement between
the parties from 2012. Liquidia now will have the right to apply PRINT to all inhaled formulations other than certain identified GSK proprietary
molecules. GSK will retain a non-exclusive, non-sublicensable, royalty-free license for the sole purpose of conducting pre-clinical research
and pre-clinical development.
Roger Jeffs, Chief Executive Officer of Liquidia, stated: "We
are very happy to have re-structured our relationship with GSK to enable both parties to maximize the proven benefits of PRINT technology
for inhaled delivery. As demonstrated by YUTREPIA , the ability to precisely engineer uniform particles for inhalation can enhance
patient benefits. This agreement will enable Liquidia to develop more products and collaborations that leverage the proprietary benefits
of PRINT to deliver high-value, inhaled medicines. At the same time, GSK will be able to explore the use of PRINT for potential new therapies."
As background, Liquidia and GSK entered a collaboration in June 2012
to research applications of PRINT technology to inhaled therapies. After the exercise of GSK's option under the collaboration agreement
in September 2015, it had a worldwide license to certain intellectual property related to PRINT that was exclusive in the field of
inhaled therapeutics other than inhaled treprostinil. Under the terms of the new agreement, GSK will be required to seek an expanded license
before it may use PRINT for clinical or commercial purposes.
About YUTREPIA (treprostinil) inhalation
YUTREPIA is an investigational, inhaled dry
powder formulation of treprostinil delivered through a proven, convenient, palm-sized device. On November 5, 2021, the U.S. Food
and Drug Administration (FDA) issued a tentative approval for YUTREPIA, which is indicated 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. The
FDA has confirmed that YUTREPIA may add the indication to treat pulmonary hypertension with interstitial lung disease (PH-ILD) 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.
Tyvaso is a registered trademarks of
United Therapeutics 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). 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.
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 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 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.
Senior Vice President, Corporate Development and Strategy