Liquidia Announces Generic Treprostinil Injection Will Be Available for Subcutaneous Route of Administration
March 30 2021 - 7:00AM
Liquidia Corporation (NASDAQ: LQDA) (“Liquidia” or the “Company”)
today announced that Treprostinil Injection, a generic form of
Remodulin®, will soon be available for subcutaneous (“SC”)
administration to treat patients diagnosed with pulmonary arterial
hypertension (“PAH”).
On March 26, 2021, the U.S. Food and Drug Administration (“FDA”)
cleared the 510(k) application submitted by Liquidia PAH’s
manufacturing partner, Chengdu Shifeng Medical Technologies LTD
(“Chengdu”) for the RG 3ml Medication Cartridge which is indicated
for use with the CADD-MS 3 pump. Manufactured by Smiths Medical,
the CADD-MS 3 pump has been used for the SC administration of
Remodulin for more than 10 years.
Damian deGoa, Liquidia’s Chief Executive Officer, said: “We are
very thankful for the effort and support Chengdu has demonstrated
to enable the subcutaneous administration of Treprostinil
Injection. We worked hard to overcome this obstacle, and we can now
offer generic Treprostinil Injection to more than double the number
of PAH patients. We will continue to offer patients, prescribers
and payers the same high-touch services and support but at a lower
cost compared to the branded product.”
Since commercial launch two years ago, Treprostinil Injection
has only been used for intravenous administration. The cartridges
required to operate the only subcutaneous pump that could deliver
treprostinil injection (CADD-MS 3) were not made available to
patients using generic treprostinil injection. The introduction of
the RG 3ml Medication Cartridge will enable the launch of SC
administration of Treprostinil Injection for the first time.
Remodulin® (treprostinil) is a registered trademark of United
Therapeutics Corporation.CADD-MS® 3 is a registered trademark of
Smiths Medical ASD, Inc.
About Treprostinil InjectionTreprostinil
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 Liquidia CorporationLiquidia
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 is developing two product candidates: LIQ861, an
inhaled dry powder formulation of treprostinil for the treatment of
PAH, and LIQ865, an injectable, sustained-release formulation of
bupivacaine for the management of local post-operative pain for
three to five days after a procedure. Liquidia PAH provides the
commercialization for rare disease pharmaceutical products, such as
Treprostinil Injection.
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 anticipate submission
contents and timelines, including our potential response to the
Complete Response Letter received in November 2020, the potential
for eventual FDA approval of the 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
its inter partes review with the PTAB, the issuance of
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the expected benefits and synergies from the Merger Transaction are
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as well as a number of uncertainties and assumptions. Moreover, we
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Liquidia Corporation is headquartered in Research
Triangle Park, NC. For more information, please
visit www.liquidia.com.
Contact InformationMedia &
Investors:Jason AdairVice President, Corporate Development
and Strategy919.328.4400jason.adair@liquidia.com
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