Court Finds United Therapeutics’ Interference with Launch of Generic Treprostinil Injection Caused Losses of More Than $137 Million
Liquidia (NASDAQ: LQDA) announced that the U.S. District Court for New Jersey has found United Therapeutics' interference with the launch of generic Treprostinil Injection caused losses exceeding $137 million. This decision stems from a 2019 lawsuit filed by Liquidia PAH and Sandoz against United Therapeutics, alleging violations of antitrust laws and unfair competition. The court granted partial summary judgments in March 2022 and has now determined damages from the breach of contract by United Therapeutics.
The final damage award is yet to be determined and will be offset by costs avoided by Sandoz. Proceeds from the litigation will be split equally between Sandoz and Liquidia PAH, with Liquidia PAH's share further divided between Henderson SPV, and PBM RG Holdings, due to litigation finance agreements.
Liquidia (NASDAQ: LQDA) ha annunciato che il Tribunale Distrettuale degli Stati Uniti per il New Jersey ha ritenuto che l'interferenza di United Therapeutics con il lancio dell'Iniezione di Treprostinil generico ha causato perdite superiori a 137 milioni di dollari. Questa decisione deriva da una causa intentata nel 2019 da Liquidia PAH e Sandoz contro United Therapeutics, accusando violazioni delle leggi antitrust e concorrenza sleale. Il tribunale ha emesso giudizi parziali nel marzo 2022 e ha ora determinato il risarcimento per la violazione del contratto da parte di United Therapeutics.
La somma finale da risarcire deve ancora essere determinata e sarà compensata dai costi evitati da Sandoz. I proventi del contenzioso saranno suddivisi equamente tra Sandoz e Liquidia PAH, con la quota di Liquidia PAH ulteriormente suddivisa tra Henderson SPV e PBM RG Holdings, a causa degli accordi di finanziamento del contenzioso.
Liquidia (NASDAQ: LQDA) anunció que el Tribunal de Distrito de EE. UU. para Nueva Jersey ha determinado que la interferencia de United Therapeutics con el lanzamiento de la Inyección de Treprostinil genérica causó pérdidas que superan los 137 millones de dólares. Esta decisión proviene de una demanda presentada en 2019 por Liquidia PAH y Sandoz contra United Therapeutics, alegando violaciones de las leyes antimonopolio y competencia desleal. El tribunal emitió juicios sumarios parciales en marzo de 2022 y ahora ha determinado los daños por la violación del contrato por parte de United Therapeutics.
El monto final de daños aún no ha sido determinado y se compensará con los costos evitados por Sandoz. Los ingresos del litigio se dividirán equitativamente entre Sandoz y Liquidia PAH, con la parte de Liquidia PAH dividida adicionalmente entre Henderson SPV y PBM RG Holdings, debido a acuerdos de financiamiento de litigios.
Liquidia (NASDAQ: LQDA)는 미국 뉴저지 지방법원이 유나이티드 테라퓨틱스의 일반 트레프로스티닐 주사제 출시 방해로 인해 1억 3천7백만 달러 이상의 손실이 발생했다고 판단했다고 발표했습니다. 이 결정은 2019년 Liquidia PAH와 Sandoz가 유나이티드 테라퓨틱스를 상대로 제기한 반독점법 및 불공정 경쟁 위반에 대한 소송에서 비롯되었습니다. 법원은 2022년 3월에 부분 요약 판결을 내렸고, 이제 유나이티드 테라퓨틱스의 계약 위반으로 인한 손해액을 결정했습니다.
최종 손해 배상금은 아직 결정되지 않았으며, Sandoz가 피한 비용으로 상쇄됩니다. 소송으로 인한 수익은 Sandoz와 Liquidia PAH 사이에 균등하게 나누어질 것입니다, Liquidia PAH의 몫은 Henderson SPV와 PBM RG Holdings 간에 추가로 나뉘어집니다, 이는 소송 자금 조달 계약 때문입니다.
Liquidia (NASDAQ: LQDA) a annoncé que le tribunal de district des États-Unis pour le New Jersey a constaté que l'ingérence de United Therapeutics dans le lancement de l'injection de Treprostinil générique a causé des pertes dépassant 137 millions de dollars. Cette décision découle d'une poursuite intentée en 2019 par Liquidia PAH et Sandoz contre United Therapeutics, alléguant des violations des lois antitrust et de la concurrence déloyale. Le tribunal a accordé des jugements sommaires partiels en mars 2022 et a maintenant déterminé les dommages liés à la violation de contrat par United Therapeutics.
Le montant final des dommages n'a pas encore été déterminé et sera compensé par les coûts évités par Sandoz. Les revenus du litige seront répartis également entre Sandoz et Liquidia PAH, la part de Liquidia PAH étant ensuite divisée entre Henderson SPV et PBM RG Holdings, en raison des accords de financement du litige.
Liquidia (NASDAQ: LQDA) gab bekannt, dass das US-Bezirksgericht für New Jersey festgestellt hat, dass die Einmischung von United Therapeutics bei der Einführung von generischen Treprostinil-Injektionen Verluste von über 137 Millionen Dollar verursacht hat. Diese Entscheidung geht auf eine Klage zurück, die 2019 von Liquidia PAH und Sandoz gegen United Therapeutics eingereicht wurde und Verstöße gegen das Antitrustrecht und unlauteren Wettbewerb geltend macht. Das Gericht hat im März 2022 teilweise Zusammenfassungsurteile gefällt und nun die Schäden aufgrund der Vertragsverletzung durch United Therapeutics bestimmt.
Die endgültige Schadensersatzsumme steht noch nicht fest und wird durch die von Sandoz vermiedenen Kosten ausgeglichen. Die Einnahmen aus dem Rechtsstreit werden gleichmäßig zwischen Sandoz und Liquidia PAH aufgeteilt, wobei der Anteil von Liquidia PAH weiter zwischen Henderson SPV und PBM RG Holdings aufgeteilt wird, aufgrund von Finanzierungsvereinbarungen für Rechtsstreitigkeiten.
- Court found United Therapeutics liable for interference with generic Treprostinil Injection launch
- Losses determined to be in excess of $137 million
- Liquidia to receive 50% of the proceeds from the litigation
- Final damage award yet to be determined
- Award will be offset by costs avoided by Sandoz
- Liquidia PAH's share of proceeds will be divided between litigation finance partners, resulting in no net proceeds for the company
Insights
The court's decision finding United Therapeutics liable for interference with the launch of generic Treprostinil Injection is a significant legal victory for Liquidia and Sandoz. This ruling addresses anticompetitive practices in the pharmaceutical industry, potentially setting a precedent for future cases. The damages exceeding
However, it's important to note that the final damage award is yet to be determined and will be offset by costs avoided by Sandoz. Additionally, the possibility of appeals adds uncertainty to the outcome. The even split of proceeds between Sandoz and Liquidia PAH and the subsequent division with litigation financiers, means that Liquidia itself may not directly benefit financially from this ruling.
While the court's decision appears favorable for Liquidia, the financial implications are complex. The
- Proceeds will be split evenly with Sandoz
- Liquidia PAH's share will go entirely to litigation financiers
- The final award is subject to offsets and potential appeals
Investors should focus on Liquidia's core business rather than anticipating a significant financial boost from this ruling. The company's ability to compete more freely in the treprostinil market may have more long-term value than the immediate financial impact of this decision.
This ruling could have broader implications for the pulmonary hypertension treatment market. By addressing anticompetitive practices, it may pave the way for increased generic competition in this space. Potential outcomes include:
- Lower prices for treprostinil treatments
- Increased market share for generic manufacturers
- Pressure on innovator companies to focus on new drug development
For Liquidia, this could mean improved market positioning for their treprostinil products. However, the long-term impact will depend on how this decision influences market dynamics and regulatory scrutiny in the rare disease pharmaceutical sector.
MORRISVILLE, N.C., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) (Liquidia), a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary diseases, announced today that the United States District Court for the District of New Jersey (District Court) has found that the interference by United Therapeutics Corporation (United Therapeutics) with the launch of generic Treprostinil Injection caused losses in excess of
Dr. Roger Jeffs, Ph.D., Chief Executive Officer of Liquidia, stated: “We are pleased with the court’s decision to find United Therapeutics liable for its interference with the launch of generic Treprostinil Injection. The company’s actions not only harmed us as competitors, but also harmed the healthcare system and pulmonary hypertension patients who were denied an alternative and more affordable treatment option. This is yet another positive milestone on our years-long fight with United Therapeutics to ensure that patients and healthcare providers have the treatment options they deserve and so desperately need.”
The decision arises from the lawsuit filed in April 2019 by Liquidia PAH and Sandoz against United Therapeutics and another party in the District Court of New Jersey (Case No. No. 3:19 cv 10170), in which Liquidia PAH and Sandoz alleged that United Therapeutics violated the Sherman Antitrust Act of 1890, state law antitrust statutes, unfair competition statutes and a prior settlement agreement between Sandoz and United Therapeutics by taking calculated steps to restrict and interfere with the launch of generic Treprostinil Injection. Specifically, Liquidia PAH and Sandoz alleged that United Therapeutics and another party entered into anticompetitive agreements whereby restrictions were placed on the cartridges necessary for the subcutaneous administration of treprostinil such that they could not be used for generic Treprostinil Injection.
In March 2022, the District Court issued an order granting partial summary judgment to United Therapeutics with respect to the antitrust and unfair competition claims and granting partial summary judgment to Sandoz with respect to the breach of contract claim. After a trial, the District Court determined the damages caused by the breach of contract by United Therapeutics. Although the losses were determined by the District Court to be in excess of
Under the agreement between Sandoz and Liquidia PAH, all proceeds from the litigation will be divided evenly between Sandoz and Liquidia PAH. Under the litigation finance agreements that Liquidia PAH has entered into with Henderson SPV, LLC (Henderson) and PBM RG Holdings, LLC (PBM), any net proceeds received by Liquidia PAH with respect to the damage award will be divided between Henderson and PBM such that no net proceeds will be retained by Liquidia PAH.
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 Sandoz, Inc., who holds the Abbreviated New Drug Application (ANDA) with the FDA.
About Liquidia Corporation
Liquidia Corporation is a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary diseases. The company’s current focus spans the development and commercialization of products in pulmonary hypertension and other applications of its proprietary PRINT® Technology. PRINT enabled the creation of Liquidia’s lead candidate, YUTREPIA™ (treprostinil) inhalation powder, an investigational drug for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The company is also developing L606, an investigational sustained-release formulation of treprostinil administered twice-daily with a next-generation nebulizer, and currently markets generic Treprostinil Injection for the treatment of PAH. To learn more about Liquidia, please visit www.liquidia.com.
Tyvaso® and Tyvaso DPI® are registered trademarks of United Therapeutics Corporation.
Cautionary Statements Regarding Forward-Looking Statements
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 the timeline or outcome of our lawsuits, including rehearings or appeals of decisions in any such proceedings, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein. The favorable decisions of courts or other tribunals are not determinative of the outcome of the appeals or rehearings of the decisions. The voluntary dismissal of a lawsuit without prejudice allows the underlying claims to be reasserted and does not address the merits of the underlying claims. 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, 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 Information
Investors:
Jason Adair
919.328.4350
jason.adair@liquidia.com
Media:
Patrick Wallace
919.328.4383
patrick.wallace@liquidia.com
FAQ
What was the court's decision regarding United Therapeutics' interference with Treprostinil Injection?
When was the lawsuit against United Therapeutics filed by Liquidia PAH and Sandoz?
How will the proceeds from the litigation be divided for Liquidia (LQDA)?
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