Liquidia Announces Generic Treprostinil Injection Now Also Available for Subcutaneous Route of Administration
May 24 2021 - 4:05PM
Liquidia Corporation (NASDAQ: LQDA) (“Liquidia” or the “Company”)
today announced that Sandoz Treprostinil Injection, a generic form
of Remodulin®, is now also available for subcutaneous (“SC”)
administration to treat patients diagnosed with pulmonary arterial
hypertension (“PAH”).
Sandoz Treprostinil Injection was the first fully-substitutable
AP rated generic version of Remodulin. Both options for intravenous
and SC administration of Sandoz generic Treprostinil Injection are
now available at the same specialty pharmacy that dispenses the
brand name medicine.
On May 21, 2021, Liquidia PAH’s manufacturing partner, Chengdu
Shifeng Medical Technologies LTD (“Chengdu”) began selling the RG
3ml Medication Cartridge, which may be used to supply medications
to PAH patients. Liquidia had previously announced the FDA’s
clearance of Chengdu’s 510(k) supporting the use of the cartridge
with the CADD-MS 3 pump manufactured by Smiths Medical, which has
been used for the SC administration of Remodulin for more than 10
years.
Scott Moomaw, Liquidia’s Senior Vice President of Commercial,
said: “We are excited to provide a new option in the parenteral use
of Treprostinil Injection. Patients who need and depend on
subcutaneously administered treprostinil will now, for the first
time, have access to a lower cost generic treprostinil. Through our
agreement with Sandoz, we will continue to provide the same level
of high-touch support and services to our patients, but at a lower
cost compared to the branded product.”
Since commercial launch two years ago, Sandoz Treprostinil
Injection has only been used for intravenous administration. The
cartridges required to operate the CADD-MS 3 pump were not
available to patients using generic Treprostinil Injection due to
restrictions imposed by other companies. The introduction of the RG
3ml Medication Cartridge has enabled the use of SC administration
of Sandoz Treprostinil Injection for the first time.
Keren Haruvi, President, Sandoz Inc. said: “The FDA clearance of
a path to bring additional new cartridges required for subcutaneous
administration of this medicine means another option for patients
who need access to this life-enhancing pulmonary arterial
hypertension medicine. Sandoz has a strong track record for
manufacturing high-quality generic medicines and supplying them
reliably to the patients who need them.”
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
Sandoz, Inc., 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 LIQ861, an inhaled dry powder
formulation of treprostinil for the treatment of PAH. Liquidia PAH
provides the commercialization for rare disease pharmaceutical
products, such as Sandoz 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 submission contents and
timelines, including our 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 our inter partes review with 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 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 InformationMedia &
Investors:Jason AdairVice President, Corporate Development
and Strategy919.328.4400jason.adair@liquidia.com
Liquidia (NASDAQ:LQDA)
Historical Stock Chart
From Aug 2024 to Sep 2024
Liquidia (NASDAQ:LQDA)
Historical Stock Chart
From Sep 2023 to Sep 2024