Liquidia and Pharmosa Biopharm Expand Collaboration to Develop Sustained Release Inhaled Treprostinil (L606)
Liquidia (NASDAQ: LQDA) and Pharmosa Biopharm have expanded their collaboration for the development and commercialization of L606, an inhaled, sustained-release formulation of treprostinil for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The amended agreement extends Liquidia's licensed territory beyond North America to include key markets in Europe, Japan, and elsewhere.
Liquidia will pay Pharmosa a $3.5 million upfront payment and up to $157.75 million in additional milestone payments. The collaboration includes rights to Pharmosa's next-generation smart-technology nebulizers. Clinical data for L606 has shown encouraging results, with favorable tolerability and a pharmacokinetic profile supporting twice-daily administration.
Liquidia (NASDAQ: LQDA) e Pharmosa Biopharm hanno ampliato la loro collaborazione per lo sviluppo e la commercializzazione di L606, una formulazione inalata a rilascio prolungato di treprostinil per iperestruzione arteriosa polmonare (PAH) e iperestruzione polmonare associata a malattie interstiziali polmonari (PH-ILD). L'accordo modificato estende il territorio autorizzato di Liquidia oltre il Nord America, includendo i mercati chiave in Europa, Giappone e altrove.
Liquidia pagherà a Pharmosa un pagamento iniziale di 3,5 milioni di dollari e fino a 157,75 milioni di dollari in ulteriori pagamenti legati a traguardi. La collaborazione include i diritti sui nebulizzatori di nuova generazione dotati di tecnologia intelligente di Pharmosa. I dati clinici per L606 hanno mostrato risultati incoraggianti, con una tollerabilità favorevole e un profilo farmacocinetico che supporta la somministrazione due volte al giorno.
Liquidia (NASDAQ: LQDA) y Pharmosa Biopharm han ampliado su colaboración para el desarrollo y la comercialización de L606, una formulación inhalada de liberación sostenida de treprostinil para hipertensión arterial pulmonar (PAH) y hipertensión pulmonar asociada a enfermedades pulmonares intersticiales (PH-ILD). El acuerdo modificado amplía el territorio licenciado de Liquidia más allá de América del Norte para incluir mercados clave en Europa, Japón y otros lugares.
Liquidia pagará a Pharmosa un pago inicial de 3,5 millones de dólares y hasta 157,75 millones de dólares en pagos adicionales por hitos. La colaboración incluye derechos sobre los nebulizadores de tecnología inteligente de próxima generación de Pharmosa. Los datos clínicos de L606 han mostrado resultados alentadores, con una tolerabilidad favorable y un perfil farmacocinético que respalda la administración dos veces al día.
Liquidia (NASDAQ: LQDA)와 Pharmosa Biopharm이 폐동맥고혈압 (PAH) 및 간질성 폐 질환과 관련된 폐 고혈압 (PH-ILD)을 위한 지속 방출 형태의 흡입용 treprostinil인 L606의 개발 및 상업화를 위한 협력을 확대했습니다. 수정된 계약은 Liquidia의 라이선스 지역을 북미를 넘어 유럽, 일본 및 기타 주요 시장으로 확장합니다.
Liquidia는 Pharmosa에 350만 달러의 선불금을 지급하고 최대 1억 5775만 달러의 추가 이정표 지급금을 지급합니다. 이 협력은 Pharmosa의 차세대 스마트 기술 네뷸라이저에 대한 권리를 포함하고 있습니다. L606에 대한 임상 데이터는 긍정적인 결과를 보여주었으며, 일일 두 번의 투여를 지지하는 유리한 약물 동태 프로필을 가지고 있습니다.
Liquidia (NASDAQ: LQDA) et Pharmosa Biopharm ont élargi leur collaboration pour le développement et la commercialisation de L606, une formulation inhalée à libération prolongée de tréprostinil pour hypertension artérielle pulmonaire (PAH) et hypertension pulmonaire associée aux maladies interstitielles des poumons (PH-ILD). L'accord modifié étend le territoire sous licence de Liquidia au-delà de l'Amérique du Nord pour inclure des marchés clés en Europe, au Japon et ailleurs.
Liquidia versera à Pharmosa un paiement initial de 3,5 millions de dollars et jusqu'à 157,75 millions de dollars de paiements supplémentaires liés à des jalons. La collaboration comprend des droits sur les nébuliseurs de nouvelle génération à technologie intelligente de Pharmosa. Les données cliniques concernant L606 ont montré des résultats encourageants, avec une tolérance favorable et un profil pharmacocinétique compatible avec une administration deux fois par jour.
Liquidia (NASDAQ: LQDA) und Pharmosa Biopharm haben ihre Zusammenarbeit zur Entwicklung und Vermarktung von L606, einer inhalierbaren, nachhaltig freisetzenden Formulierung von Treprostinil für pulmonale arterielle Hypertonie (PAH) und pulmonale Hypertonie im Zusammenhang mit interstitiellen Lungenerkrankungen (PH-ILD), erweitert. Die geänderte Vereinbarung erweitert Liquidias lizenziertes Territorium über Nordamerika hinaus und umfasst wichtige Märkte in Europa, Japan und anderswo.
Liquidia wird Pharmosa eine Vorauszahlung von 3,5 Millionen Dollar und bis zu 157,75 Millionen Dollar in zusätzlichen Meilensteinzahlungen zahlen. Die Zusammenarbeit umfasst die Rechte an Pharmosas nächster Generation von Nebelgeräten mit intelligenter Technologie. Klinische Daten zu L606 haben ermutigende Ergebnisse gezeigt, mit einer günstigen Verträglichkeit und einem pharmakokinetischen Profil, das eine zweimal tägliche Verabreichung unterstützt.
- Expanded licensing agreement to include key markets in Europe, Japan, and elsewhere
- Rights obtained for Pharmosa's next-generation smart-technology nebulizers
- Encouraging clinical data for L606 with favorable tolerability profile
- L606 demonstrates therapeutic levels up to 12 hours and 7-times lower peak plasma concentration compared to Tyvaso®
- Potential for twice-daily administration of L606 using breath-actuated, smart-technology nebulizer
- Upfront payment of $3.5 million to Pharmosa
- Additional milestone payments of up to $157.75 million
- Royalties payable on global net sales of L606 (low, double-digit)
Insights
The expanded collaboration between Liquidia and Pharmosa for L606 is a significant development in the pulmonary hypertension treatment landscape. This inhaled, sustained-release formulation of treprostinil addresses key limitations of current therapies:
- Improved convenience with twice-daily dosing, compared to four times daily for Tyvaso
- Potentially better tolerability due to lower peak plasma concentrations
- Continuous drug coverage during sleeping and waking hours
- Use of smart-technology nebulizers for easier administration
The expansion into European and Japanese markets is crucial, as there are no approved treatments for PH-ILD outside the U.S. With over 100,000 PAH and PH-ILD patients in major countries outside North America, this represents a significant market opportunity. The favorable clinical data to date, including tolerability up to 378 mcg twice daily, suggests L606 could be a competitive option in this space.
This deal significantly expands Liquidia's market potential for L606. Key financial aspects include:
$3.5 million upfront payment to Pharmosa- Up to
$157.75 million in additional milestone payments - Maintained low double-digit royalty structure on global net sales
The expanded territory rights and access to next-generation nebulizers enhance Liquidia's competitive position. While the upfront cost is modest, the milestone structure aligns interests and reduces immediate financial burden. The deal structure allows Liquidia to leverage Pharmosa's manufacturing capabilities while controlling development and commercialization.
For a company with a market cap of
- Liquidia amends exclusive license to include key markets in Europe, Japan and elsewhere
- Liquidia also obtains rights to Pharmosa’s next-generation nebulizers for use with L606
- Pharmosa to receive
$3.5 million upfront and up to$157.75 million in additional development and sales milestones tied to commercial sales outside of North America
MORRISVILLE, N.C., Oct. 02, 2024 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary diseases, and Pharmosa Biopharm (Pharmosa) today announced that they have amended the current exclusive licensing agreement for the development and commercialization of L606, an inhaled, sustained-release formulation of treprostinil currently being evaluated in a clinical trial for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The amended agreement expands Liquidia’s licensed territory beyond North America to include key markets in Europe, Japan and elsewhere. Pharmosa will retain certain territories, including China, Korea, Taiwan, Middle East, North Africa, Turkey and Southeast Asia.
Liquidia has also obtained certain rights to Pharmosa’s next-generation smart-technology nebulizers for use with its proprietary liposomal drug formulations. Unlike current nebulized treatments for PAH and PH-ILD, these palm-sized, lightweight, virtually silent nebulizers provide portability like a dry-powder inhaler and rapidly deliver a dose using breath-actuated smart technology that adapts to a patient’s normal breathing pattern.
Dr. Rajeev Saggar, Chief Medical Officer of Liquidia, stated: “This is a great example of our approach to research and development in pulmonary hypertension. This partnership has the potential to be transformational for people living with PAH and PH-ILD, as it will combine Liquidia’s expertise as a leader in the field of pulmonary hypertension with Pharmosa’s deep experience in inhaled liposomal formulations. We are delighted by the interest from the global medical and patient communities, many of which lack access to inhaled formulations of treprostinil, as we prepare to initiate the L606 pivotal study in PH-ILD later this year. We are also encouraged by the recent scientific advice from the European Medicines Agency that supports our plan to proceed with the study as designed.”
Pei Kan, Ph.D., President of Pharmosa, added: “This expanded partnership with Liquidia is a strong endorsement for our L606 programs and our contribution to the fight against pulmonary hypertension including PAH and PH-ILD. With more than 100,000 PAH and PH-ILD patients in the major countries outside North America, improvements of the treatment strategies in this region are essential since there is no approved treatment for PH-ILD outside the U.S. We believe Liquidia’s commitment to move quickly and execute its global clinical program will accelerate the potential for long-term value creation for both parties in this partnership.”
Consistent with the agreement from June 2023, Liquidia will be responsible for the development, regulatory and commercial activities of L606 in the expanded territory. Pharmosa will continue to manufacture clinical and commercial supplies of L606. In consideration for these incremental exclusive rights, Liquidia will pay Pharmosa an upfront payment of
Clinically, L606 continues to generate encouraging data in an open-label safety study in the United States in both PAH and PH-ILD. As reported in a poster presentation at the 2024 American Thoracic Society International Conference, the tolerability and titratability profile of L606 observed to date has been favorable up to the maximum dose allowed in the study of 378 mcg twice daily, a dosage comparable to 26 to 28 breaths of Tyvaso administered four times daily. Pharmacokinetic studies in healthy volunteers demonstrated therapeutic levels of L606 up to 12 hours and 7-times lower peak plasma concentration compared to Tyvaso®. The increased apparent half-life of L606, in concert with comparable systemic exposure and clearance rate, suggests that L606 provides controlled, continuous drug coverage during sleeping and waking hours, and supports twice-daily administration using a breath-actuated, smart-technology nebulizer.
About L606 (liposomal treprostinil) Inhalation Suspension
L606 is an investigational, liposomal formulation of treprostinil administered twice-daily with a short-duration next-generation nebulizer. The L606 suspension uses Pharmosa’s proprietary liposomal formulation to encapsulate treprostinil which can be released slowly at a controlled rate into the lung, enhancing drug exposure over an extended period and reducing local irritation of the upper respiratory tract. L606 is currently being evaluated in an open-label study in the United States for treatment of pulmonary arterial hypertension (PAH) with a planned pivotal study for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD).
About Pulmonary Arterial Hypertension (PAH)
Pulmonary arterial hypertension (PAH) is a rare, chronic, progressive disease caused by hardening and narrowing of the pulmonary arteries that can lead to right heart failure and eventually death. Currently, an estimated 45,000 patients are diagnosed and treated in the United States. There is currently no cure for PAH, so the goals of existing treatments are to alleviate symptoms, maintain or improve functional class, delay disease progression, and improve quality of life.
About Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)
Pulmonary hypertension (PH) associated with interstitial lung disease (ILD) includes a diverse collection of up to 150 different pulmonary diseases, including interstitial pulmonary fibrosis, chronic hypersensitivity pneumonitis, connective tissue disease related ILD, and sarcoidosis among others. Any level of PH in ILD patients is associated with poor 3-year survival between 30 to
About Liquidia Corporation
Liquidia Corporation is a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease. 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 https://www.liquidia.com.
About Pharmosa Biopharm
Pharmosa Biopharm Inc. (PBI) is a Taiwan-based biotechnology company focused on developing new drugs by exploiting its proprietary liposomal formulations and manufacturing technology. With regional and global strategic partnerships, PBI develops products through 505(b)(2) or hybrid applications to regulatory authorities with the intent to expand the clinical potential of existing drugs by exploiting innovative delivery formulations and medical devices. For more information, please visit https://www.pharmosa.com.tw.
Tyvaso® is a registered trademark 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 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, 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, 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 is the expanded collaboration between Liquidia and Pharmosa Biopharm for?
What new territories are included in Liquidia's (LQDA) expanded license for L606?
What financial terms are involved in the expanded collaboration between Liquidia (LQDA) and Pharmosa?
What clinical advantages does L606 show compared to Tyvaso® according to the press release?
