On the 8th, Pharmosa Biopharm announced that it received notification from its North American licensing partner, Liquidia Technologies, Inc. (Liquidia), regarding the commencement of a global Phase III clinical trial for the new drug L606. Liquidia has successfully completed consultations with the European Medicines Agency (EMA) on the design of the Phase III clinical trial for L606, which is aimed at treating pulmonary hypertension associated with interstitial lung disease (PH-ILD). The trial design was also agreed upon during a Type C meeting with the U.S. FDA late last year. Based on the feedback from the U.S. FDA and the European EMA, Liquidia will finalize the clinical trial design and plans to initiate the global Phase III trial for PH-ILD later this year.
The feedback received from both the European EMA and the U.S. FDA is advantageous for Pharmosa's efforts to negotiate licensing deals for L606 in markets outside of North America, including Europe, Japan, and the Middle East. Pharmosa also stated that final-stage negotiations are currently underway with specific parties in various regional markets.
According to market research, the number of PH-ILD patients in major countries such as North America, Europe, and Japan is approximately 60,000, 57,000, and 22,000, respectively. Additionally, the combined patient population in the Middle East, China, and Taiwan exceeds 100,000. Currently, the only available treatment in North America is Tyvaso/Tyvaso DPI, which requires an inhalation regimen every four hours or four times a day. Tyvaso generated $1.234 billion in revenue in 2023, with a projected growth rate of over 30% in 2024, potentially reaching $1.6 billion. However, there are no available treatments for PH-ILD patients outside of North America, including in Europe, Japan, and China.
Pharmosa is developing L606, a new generation inhalable drug (liposomal treprostinil), designed as a long-acting sustained-release medication. The treatment requires inhalation only twice a day, every 12 hours, providing 24-hour coverage. This new regimen reduces upper respiratory tract irritation and effectively improves the convenience and side effects associated with current treatments.
Pharmosa plans to launch L606 globally, aiming not only to provide North American patients with a better treatment option but also to introduce the first available treatment for PH-ILD patients in countries where no such therapies currently exist.
Resource (mandarin): 國邑接獲授權夥伴Liquidia通知L606將啟動全球三期臨床試驗
