On November 13, Pharmosa Biopharm held an investor conference where General Manager Pei Kan shared updates on the company’s progress. The company achieved its goal of securing two regional licensing deals for its L606 combination drug-device treatment ahead of schedule this year and will continue to pursue partnerships in other key markets. Additionally, L608 recently received positive feedback from a pre-IND meeting with the U.S. FDA, and a Phase II clinical trial application for systemic sclerosis-related digital ulcers (SSc-RP/DU) is expected by mid-2025. With these two promising drug candidates, the company remains optimistic about its growth prospects.
After granting exclusive licensing rights for L606 to U.S.-based Liquidia last year, Pharmosa has since expanded its reach by signing agreements with Menagen for exclusive rights in the Middle East, North Africa, and Turkey (MENAT) and amending its deal with Liquidia to cover Europe, Japan, and other major markets. To date, disclosed licensing milestone payments for L606 total $386.25 million (approximately NT$12.3 billion), setting a record for licensing agreements in the global inhaled pulmonary arterial hypertension (PAH) treatment market.
Kan highlighted that Liquidia, one of the top two U.S. companies in treprostinil-based therapies, has robust clinical trial expertise. The strengthened partnership with Liquidia leverages their U.S. Phase III clinical trial experience and data for PAH, accelerating L606’s potential for global Phase III trials targeting PH-ILD (pulmonary hypertension associated with interstitial lung disease). Pharmosa aims for L606 to become the first approved treatment for PH-ILD worldwide.
L606, a liposome-encapsulated formulation of treprostinil for PAH and PH-ILD, is paired with a proprietary nebulizer developed by Pharmosa, securing a competitive edge with its integrated “drug + device” technology.
In the current PAH market, Tyvaso is the sole competing drug. However, Tyvaso requires four doses per day, while L606 offers continuous coverage with only two doses per day, avoiding nighttime interruptions and reducing upper respiratory side effects. Liquidia’s interim Phase III results for PAH indicate excellent safety and long-term treatment stability, positioning L606 favorably for future market expansion.
Meanwhile, other candidates in clinical stages, such as those by Aerovate and Aerami, have either failed or withdrawn from competition. In the PH-ILD field, despite an influx of drug development efforts, L606 maintains a leading position.
Kan noted that PAH, often referred to as the “cancer of the heart” due to its high mortality rates and diagnostic challenges, stands to benefit from advances in diagnostic and remote monitoring technologies. The global PAH market, driven by ongoing therapeutic innovation, is projected to reach $12.2 billion by 2032, with a 5.5% CAGR. Pharmosa is confident that L606 will offer a new hope for patients.
Operationally, licensing milestone revenue from L606 contributed to October sales reaching NT$113 million, with cumulative revenue for the first ten months totaling NT$163 million. Despite ongoing R&D expenses for its unmarketed drugs, the company holds NT$1.613 billion in cash and cash equivalents, sufficient to fund current clinical trials. Pharmosa also continues to pursue licensing for L606 in key markets, including China, South Korea, and Southeast Asia, while exploring partnership and licensing opportunities for L608. The company remains positive about its future growth trajectory.
Resource: 國邑簽約金入帳帶動10月營收1.13億元 看好2新藥發展潛力
