Treprostinil

Liquidia Corporation Files Response to United Therapeutics Lawsuit and Files Counterclaims

Retrieved on: 
Monday, January 8, 2024
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11,826,327 (the ‘327 patent) in association with Liquidia’s New Drug Application (NDA) for YUTREPIA™ (treprostinil) inhalation powder.

Key Points: 
  • 11,826,327 (the ‘327 patent) in association with Liquidia’s New Drug Application (NDA) for YUTREPIA™ (treprostinil) inhalation powder.
  • Simultaneously, Liquidia filed counterclaims against UTHR seeking a declaration that all asserted claims of the ‘327 patent are not infringed, are invalid and are unenforceable.
  • Furthermore, the counterclaims summarize certain publications, references and information that UTHR failed to submit to the United States Patent and Trademark Office (USPTO) during the prosecution of the ‘327 patent.
  • Liquidia has also asserted that these same references and information, as set forth in the counterclaims, also render the claims of the ‘327 patent invalid.

Liquidia Corporation Reports Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, November 7, 2023
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Oral arguments in appeal of ‘793 PTAB decision set for December 4, 2023

Key Points: 
  • Oral arguments in appeal of ‘793 PTAB decision set for December 4, 2023
    PDUFA goal date to add PH-ILD indication to YUTREPIA label is January 24, 2024
    MORRISVILLE, N.C., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) (Liquidia or the Company) today reported financial results for the third quarter ended September 30, 2023.
  • ET to discuss the financial results and provide a corporate update.
  • Cash totaled $76.2 million as of September 30, 2023, compared to $93.3 million as of December 31, 2022.
  • Total other expense, net was $0.9 million for the three months ended September 30, 2023, compared with $0.3 million for the three months ended September 30, 2022.

United Therapeutics Announces First Patient Enrolled in Phase 3 TETON PPF Study of Nebulized Tyvaso in Patients with Progressive Pulmonary Fibrosis

Retrieved on: 
Tuesday, October 31, 2023
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United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that the first patient has enrolled in the registration-phase TETON PPF study, which will evaluate nebulized Tyvaso® (treprostinil) Inhalation Solution in 698 adult patients with progressive pulmonary fibrosis (PPF).

Key Points: 
  • United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that the first patient has enrolled in the registration-phase TETON PPF study, which will evaluate nebulized Tyvaso® (treprostinil) Inhalation Solution in 698 adult patients with progressive pulmonary fibrosis (PPF).
  • This is in addition to two separate ongoing registration-phase studies, TETON 1 and TETON 2, of nebulized Tyvaso in patients with another type of pulmonary fibrosis (PF) known as idiopathic pulmonary fibrosis (IPF).
  • The 52-week study will evaluate the impact of nebulized Tyvaso on a key prognostic indicator for PPF known as forced vital capacity (FVC).
  • The TETON PPF study seeks to evaluate the use of nebulized Tyvaso in PPF patients irrespective of whether or not they have PH.

FDA Accepts Submission to Add PH-ILD to YUTREPIA™ Label

Retrieved on: 
Monday, September 25, 2023
PAH, NDA, United Therapeutics, PDUFA, Orthostatic hypertension, FDA, Pulmonary hypertension, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Pharmaceutical industry, Treprostinil

The FDA confirmed the type of resubmission as Class II and has set a Prescription Drug User Fee Act (PDUFA) goal date of January 24, 2024.

Key Points: 
  • The FDA confirmed the type of resubmission as Class II and has set a Prescription Drug User Fee Act (PDUFA) goal date of January 24, 2024.
  • If this amendment is approved by FDA, YUTREPIA would be indicated for the treatment of both PH-ILD and pulmonary arterial hypertension (PAH).
  • “
    The FDA tentatively approved YUTREPIA to treat PAH in November 2021 and confirmed that the addition of the PH-ILD indication will not require any new clinical studies.
  • The launch of YUTREPIA in both indications remains subject to the successful resolution of the ongoing litigation with United Therapeutics and final FDA approval.

Liquidia Corporation Reports Second Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, August 10, 2023
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MORRISVILLE, N.C., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) (Liquidia or the Company) today reported financial results for the second quarter ended June 30, 2023.

Key Points: 
  • MORRISVILLE, N.C., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) (Liquidia or the Company) today reported financial results for the second quarter ended June 30, 2023.
  • ET to discuss the financial results and provide a corporate update.
  • Dr. Roger Jeffs, Liquidia’s Chief Executive Officer, said: “This quarter saw Liquidia significantly advance our mission to become the leading inhaled treprostinil provider for pulmonary hypertension patients.
  • Briefing in the appeal should be completed in fourth quarter 2023 and oral arguments will be heard on the next available date in the oral argument calendar, expected to be late fourth quarter 2023 to early 2024.

Liquidia Corporation Reports Full Year 2022 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, March 16, 2023
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ET

Key Points: 
  • ET
    MORRISVILLE, N.C., March 16, 2023 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) (“Liquidia” or the “Company”) today reported financial results for the full year ended December 31, 2022.
  • ET to discuss the 2022 financial results and provide a corporate update.
  • Roger Jeffs, Liquidia’s Chief Executive Officer, said: “We made notable strides toward unlocking the full potential of Liquidia in 2022.
  • If every decision in favor of Liquidia is affirmed on appeal by UTC, then Liquidia would be clear to seek final regulatory approval of YUTREPIA.

Liquidia Announces Collaboration to Develop a New Infusion Pump for Subcutaneous Delivery of Treprostinil Injection to Treat Pulmonary Arterial Hypertension (PAH)

Retrieved on: 
Monday, December 5, 2022
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Mainbridge will perform all development, validation and testing activities required for the pump and related consumables.

Key Points: 
  • Mainbridge will perform all development, validation and testing activities required for the pump and related consumables.
  • 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.
  • 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.

United Therapeutics Corporation Reports Third Quarter 2022 Financial Results

Retrieved on: 
Wednesday, November 2, 2022
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Income tax expense for the three months ended September 30, 2022 and 2021 was $73.2 million and $41.7 million, respectively.

Key Points: 
  • Income tax expense for the three months ended September 30, 2022 and 2021 was $73.2 million and $41.7 million, respectively.
  • Our first commercial shipments to specialty pharmacies occurred in June 2022 and the first patients started Tyvaso DPI therapy shortly thereafter.
  • We will host a webcast to discuss our third quarter 2022 financial results on Wednesday, November 2, 2022, at 9:00 a.m. Eastern Time.
  • ORENITRAM, REMODULIN, REMUNITY, TYVASO, TYVASO DPI, and UNITUXIN are registered trademarks of United Therapeutics Corporation and/or its subsidiaries.

United Therapeutics Announces Top Line Data From the EXPEDITE Study of Remodulin Induction Prior to Orenitram Therapy

Retrieved on: 
Monday, October 31, 2022
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Avoid use of Orenitram in patients with severe hepatic impairment (Child Pugh Class C) due to increases in systemic exposure.

Key Points: 
  • Avoid use of Orenitram in patients with severe hepatic impairment (Child Pugh Class C) due to increases in systemic exposure.
  • Abrupt discontinuation or sudden large reductions in dosage of Orenitram may result in worsening of PAH symptoms.
  • Co-administration of Orenitram and the CYP2C8 enzyme inhibitor gemfibrozil increases exposure to treprostinil; therefore, Orenitram dosage reduction may be necessary in these patients.
  • Use of Orenitram in patients aged 65 years and over demonstrated slightly higher absolute and relative adverse event rates compared to younger patients.

Precedential Opinion Panel Denies United Therapeutics’ Request for Review of ‘793 Inter Partes Review Decision

Retrieved on: 
Thursday, October 27, 2022
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The PTABs decision, which invalidated the 793 patent claims, was based on three specific pieces of prior art, one patent and two publications.

Key Points: 
  • The PTABs decision, which invalidated the 793 patent claims, was based on three specific pieces of prior art, one patent and two publications.
  • Based on these arguments presented in the IPR, the PTAB determined that the publications did constitute prior art for purposes of the 793 Patent.
  • Roger Jeffs, Chief Executive Officer of Liquidia, stated: Yesterdays decision clears the way for the PTAB to make a final decision with respect to UTCs rehearing request.
  • We believe that the requested clarification of the PTABs original decision will help to make the PTABs decision even stronger.