- Liquidia exclusively licenses in North America the rights to L606, an inhaled formulation of treprostinil administered twice daily with a next-generation short-acting nebulizer
- Liquidia funds a $10 million upfront payment from the HealthCare Royalty financing settlement
- Pharmosa to receive up to $215 million in development and sales milestones for PAH and PH-ILD indications, $10 million for each additional approved indication and additional product, and royalties on net sales of L606
- Creates an industry-leading portfolio in the rapidly expanding inhaled treprostinil market
- Liquidia will host the webcast today at 8:30 am New York time
MORRISVILLE, NC, June 28, 2023 (GLOBE NEWSWIRE) — Liquidia Corporation (NASDAQ: LQDA) (Liquidia or the Company) and Pharmosa Biopharm (Pharmosa) today announced that they have entered into an exclusive licensing agreement for the development and commercialization of North America of L606, an inhaled extended-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).
Roger Jeffs, Chief Executive Officer of Liquidia, said, L606 is the perfect complement to our pipeline lifecycle and furthers our mission to provide innovative treatment options that improve the lives of patients affected by PAH or PH-ILD. As already observed in the ongoing open-label Phase 3 study in PAH patients, the new liposomal formulation of Pharmosas offers the potential to improve patient comfort and compliance with twice-daily dosing using a next-generation nebulizer of short term. More importantly, we believe that the drug-inhaled device combination may provide best-in-class treprostinil exposure over a 24-hour period, even during sleep hours, which could translate into better efficacy, tolerability, and patient outcomes. . Our investment in this collaboration, along with our continued preparation for a potential launch of YUTREPIA (treprostinil) inhalation powder, are clear examples of Liquidias’ long-term commitment to address unmet needs in the treatment of pulmonary hypertension and enable the choice based on the preferences and circumstances of the patients.
Pei Kan, Ph.D., President of Pharmosa, added: Liquidia is the ideal partner to bring L606 to the North American market. Liquidia has shown an unwavering determination to bring new products to patients and provides clear synergies with their commercial commitment, clinical expertise and deep relationships with key opinion leaders. Pharmosa will focus on the advancement of its extended-release liposomal technology which demonstrated in L606 the ability to dramatically reduce maximum systemic drug concentrations by significantly increasing local concentrations deep in the lung.
Under the agreement, Liquidia will be responsible for the development, regulatory and commercial activities of L606 in North America. Pharmasa will manufacture clinical and commercial supplies of L606 and support Liquidia in establishing a redundant global supply chain. In consideration of these exclusive rights, Liquidia will pay Pharmosa an upfront payment of $10 million, potential sales and development milestone payments of up to $215 million tied to the PAH and PH-ILD indications, and two tiers of low double-digit royalties per net sales of L606. Pharmasa will also receive a $10 million milestone payment for each additional indication and additional product approved. Liquidia reserves the first right to negotiate for the development and commercialization of L606 in Europe and other territories should Pharmosa seek a partner, subject to the fulfillment of certain conditions established in the license agreement.
Liquidia plans to obtain the first regulatory approval of L606 in the United States under the 505(b)(2) regulatory pathway. The planned New Drug Application (NDA) is expected to include: (i) the completed Phase 1 study demonstrating tolerability and pharmacokinetics comparable to nebulized Tyvaso (treprostinil) inhalation solution; (ii) clinical data from the ongoing US open-label Phase 3 study in patients with PAH and PH-ILD; and (iii) clinical data from a double-blind, randomized, placebo-controlled study evaluating the treatment of PH-LD patients with L606. Liquidia intends to launch the PH-ILD process in the first half of 2024.
In support of today’s announcement, HealthCare Royalty (HCRx) will fund Liquidia for $10.0 million from the Revenue Interest Financing Agreement (RIFA) announced in January 2023. The RIFA included a $7.5 million discretionary funding tranche of Liquidia to support any acquisition of rights to a clinical stage or commercial stage biopharmaceutical product to diagnose, prevent or treat pulmonary hypertension. In connection with the Pharmosa settlement, HCRx agreed to upfront an additional $2.5 million of the fourth tranche of $25 million under the RIFA, which was to be funded following the mutual election of Liquidia and HCRx. Today’s announcement does not impact the $35 million tranche that will be available to Liquidia following the successful resolution of its ongoing patent litigation with United Therapeutics Corporation. Total proceeds funded in Liquidia by HCRx are now $42.5 million versus the $100 million under the RIFA. As previously announced, HCRx will receive a graduated royalty on the net revenues generated by YUTREPIA and other products marketed by Liquidia. Aggregate payments to HCRx are limited to 175% of total amounts advanced by HCRx, with Liquidia having the option to make a matched payment if HCRx’s internal rate of return is less than 18% on the date the limit is reached.
Liquidia will host a webcast call today at 8:30 am New York time. To listen to the webcast, visit https://liquidia.com/investors/events-and-presentations.
About L606 (liposomal treprostinil) inhalation suspension
L606 is an investigational liposomal formulation of treprostinil administered twice daily with a new generation short duration nebulizer. L606 suspension uses Pharmosas proprietary liposomal formulation to encapsulate treprostinil which can be released slowly at a controlled rate into the lungs, increasing exposure to the drug over a long period of time and reducing local irritation of the upper respiratory tract. L606 is currently being evaluated in an open label study in the United States for the treatment of pulmonary arterial hypertension (PAH) with a pivotal study planned for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD).
About YUTREPIA (treprostinil) inhalation powder
YUTREPIA is an experimental dry inhaled powder formulation of treprostinil delivered through a convenient, low-resistance handheld device. On November 5, 2021, the FDA issued a provisional approval for YUTREPIA, which is indicated for the treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity in adult patients with NYC functional class II-III symptoms Heart Association (NYHA). The FDA has confirmed that YUTREPIA can add an indication for the treatment of pulmonary hypertension with interstitial lung disease (PH-ILD) without further clinical trials. YUTREPIA was engineered using Liquidias PRINT technology, which enables the development of drug particles that are precise and uniform in size, shape and composition, and that are engineered for better deposition in the lung after oral inhalation. Liquidia has completed INSPIRE, or the Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil, an open-label, multi-center Phase 3 clinical study of YUTREPIA in patients diagnosed with PAH who have not received inhaled treprostinil or who are transitioning from Tyvaso (nebulised treprostinil). YUTREPIA was previously referred to as LIQ861 in experimental studies.
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 ultimately death. Currently, approximately 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 relieve 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 (PI) associated with interstitial lung disease (ILD) comprises a diverse collection of up to 150 different lung diseases, including interstitial pulmonary fibrosis, chronic hypersensitivity pneumonitis, connective tissue disease-related ILD, and sarcoidosis, among others. Any level of PH in patients with ILD is associated with a poor 3-year survival ranging from 30 to 35%. A current estimate of the prevalence of PH-ILD in the United States is greater than 60,000 patients, although population growth in many of these underlying ILD diseases is not yet known due to factors including underdiagnosis and lack of approved treatments until March 2021 with inhaled treprostinil.
About Liquidia Corporation
Liquidia Corporation is a biopharmaceutical company focused on the development and commercialization of products for 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 has developed YUTREPIA (treprostinil) inhalation powder for the treatment of pulmonary arterial hypertension (PAH). Liquidia PAH provides the marketing of pharmaceutical products for the treatment of lung diseases, such as the generic Treprostinil Injection. For more information, visit www.liquidia.com.
About Pharmamosa Biopharm
Pharmosa Biopharm Inc. (PBI) is a Taiwan-based biotechnology company focused on the development of new drugs leveraging its proprietary liposomal formulations and manufacturing technology. With strategic regional and global partnerships, PBI develops products through 505(b)(2) or hybrid applications to regulators with the intent to expand the clinical potential of existing drugs by leveraging innovative delivery formulations and medical devices. For more information, visit https://www.phharmosa.com.tw
Speaking of healthcare royalty
HCRx is a leading royalty acquisition company focused on commercial and near-commercial stage biopharmaceuticals. HCRx has cumulative capital commitments of $6.3 billion with offices in Stamford (CT), San Francisco, Boston and London. For more information, visit www.hcrx.com. HEALTHCARE ROYALTY and HCRx are registered trademarks of HealthCare Royalty Management, LLC.
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