Pharmosa Biopharm Inc. ("Pharmosa," Stock Code: 6875) announced today that patient enrollment is ongoing in "Re-Spire," the global pivotal Phase III clinical trial of L606, and that overall clinical development continues to progress. Pharmosa also provides the following update on the recent U.S. patent litigation related to pulmonary hypertension associated with interstitial lung disease (PH-ILD) involving its partner, Liquidia Corporation (Nasdaq: LQDA).
The litigation, between United Therapeutics Corporation and Liquidia, concerns YUTREPIA® (treprostinil) inhalation powder and a patent related to the treatment of PH-ILD. The U.S. District Court ruled that two of the six claims asserted against Liquidia are valid and infringed, while the remaining claims were found invalid. Liquidia has stated that it will evaluate all available appellate options and maintain market supply of YUTREPIA® for the pulmonary arterial hypertension (PAH) indication, while continuing to invest in clinical development to expand into other indications.
Regarding the global clinical development of L606, in addition to advancing the Re-Spire Phase III trial and pursuing marketing approval, Liquidia will continue to evaluate and expand into other potential indications based on the potential therapeutic applications of inhaled treprostinil, broadening the clinical development of L606.
Pharmosa stated that L606 utilizes a novel formulation technology with unique characteristics in terms of product attributes, safety profile, and effective dosage, distinguishing it from currently marketed products. The company looks forward to further validating the product characteristics and clinical potential of this novel formulation through global clinical trials. Pharmosa will continue to work with Liquidia to advance the development of L606 across its potential indications and will plan subsequent regulatory submissions and market launch strategies in line with clinical progress, further expanding the international market presence of its long-acting inhaled drug platform.
