Full Press Release Details
Announces Collaboration to Develop a New Infusion Pump for Subcutaneous Delivery of Treprostinil Injection to Treat Pulmonary Arterial
MORRISVILLE, N.C., December 5,
2022 - Liquidia Corporation (NASDAQ: LQDA) (Liquidia or the Company) announced today a collaboration with Sandoz
Inc. (Sandoz) and Mainbridge Health Partners LLC (Mainbridge) to support the development of a new subcutaneous pump for infusion of Treprostinil
Injection, a generic form of Remodulin , for which Liquidia has the exclusive rights to promote and commercialize with
Scott Moomaw, Senior Vice President of Commercial at Liquidia, stated:
"Liquidia remains committed to addressing unmet needs in the administration of treprostinil, whether it be inhaled or infused. In
order to alleviate the single-source dependence on the existing CADD-MS 3 system, Sandoz and Liquidia have found a great partner in Mainbridge
with the skills and know-how to efficiently develop a new infusion pump using technology that has been previously approved by the U.S.
Food and Drug Administration (FDA) for delivery of insulin. Our goal is to ensure the widespread availability of our trusted and proven
Treprostinil Injection to the benefit of physicians, payors and patients in the PAH community."
To enable the collaboration, Sandoz and Liquidia will enter into a
joint agreement with Mainbridge (Pump Agreement). Mainbridge will perform all development, validation and testing activities required
for the pump and related consumables. The parties anticipate submitting a 510(k) in 2023 for FDA clearance. Sandoz and Liquidia will
split equally the development costs. In connection with the execution of the Pump Agreement, Liquidia and Sandoz also agreed to extend
their promotion agreement for Treprostinil Injection by another five years until December 31, 2032.
About Treprostinil Injection
Treprostinil Injection is the first-to-file,
fully substitutable generic treprostinil for parenteral administration. Treprostinil Injection contains the same active ingredient, same
strengths, same dosage form and same inactive ingredients as Remodulin (treprostinil) and is offered to patients and physicians with
the same level of service and support, but at a lower price than the branded drug. Liquidia PAH promotes the appropriate use of Treprostinil
Injection for the treatment of PAH in the United States in partnership with its commercial partner, who holds the Abbreviated New Drug
Application (ANDA) with the FDA.
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 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. 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 optimal 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.
Remodulin and Tyvaso
are registered trademarks of United Therapeutics Corporation.
CADD-MS 3 is a registered
trademark of Smiths Medical MD, Inc.
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.
About Mainbridge Health Partners
Mainbridge Health Partners is an infusion
technology and solutions company focused on creation and development of software, process, and products for better outcomes. Mainbridge
embraces industry changing discoveries which improve patient care with proven, leading-edge technology to significantly enhance both
domestic and global healthcare products and services. Mainbridge developed FUSEBOX , a platform that runs ambulatory infusion centers
and suites. For more information, please visit www.mainbridgehp.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, the timeline or
outcome related to appeals or rehearing requests arising from our patent litigation in the U.S. District Court for the District of Delaware
or inter partes review proceedings conducted at the PTAB, 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 in the IPRs for the '793 and 901 patents and of the Court
in the Hatch-Waxman litigation are not determinative of the outcome of any appeal of those decisions. 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