Liquidia Corporation will pay Pharmosa Biopharm $10 million up front plus development and sales milestones worth up to $215 million and royalties on potential sales for North American development and commercialization rights to Pharmosa’s L606 liposomal treprostinil inhalation suspension, the company said. In addition, Liquidia will have the right of first refusal if Pharmosa offers European rights to L606, which is currently in Phase 3 development for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
Liquidia said that it will submit a 505(b)(2) NDA for L606 supported by a Phase 1 trial that compared the liposomal treprostinil to nebulized Tyvaso treprostinil; a Phase 3 trial currently underway in patients with PAH and PH-ILD; and a trial in PH-ILD patients that is expected to take place next year. L606 will be Liquidia’s second inhaled treprostinil product. In November 2021, the FDA tentatively approved Liquidia’s NDA for Yutrepia treprostinil DPI for the treatment of PAH. At this time, the company is still involved in litigation with United Therapeutics regarding patents covering Tyvaso.
Earlier this year, Liquidia announced that it had signed a deal with HealthCare Royalty (HCRx) for funding of up to $100 million. The company says that the $10 million upfront payment to Pharmosa will come out of that amount, bringing the total provided by HCRx so far to $42.5 million, and that it will not affect the $35 million that is due to be released if and when the patent litigation with United Therapeutics is resolved in Liquidia’s favor.
Liquidia CEO Roger Jeffs commented, “L606 is the perfect life-cycle complement to our pipeline and furthers our mission to provide innovative treatment options that improve the lives of patients suffering from PAH or PH-ILD. As already observed in the ongoing Phase 3 open-label study of PAH patients, Pharmosa’s novel liposomal formulation offers potential to improve patient convenience and compliance with twice-daily dosing using a short-duration, next-generation nebulizer. More importantly, we believe that the inhaled drug-device combination may provide best-in-class treprostinil exposure over a 24-hour period, including during sleeping hours, which could translate to improved efficacy, tolerability, and patient outcomes. Our investment in this collaboration, alongside our continued preparation for a potential launch of Yutrepia treprostinil inhalation powder, are clear examples of Liquidia’s long-term commitment to addressing unmet needs in treating pulmonary hypertension and enabling choice based on patients’ preferences and circumstances.”
Pharmosa President Pei Kan said, “Liquidia is the ideal partner to bring L606 to the North American market. Liquidia has shown an unflinching determination to bring novel products to patients, and provides clear synergies with their commercial effort, clinical expertise and deep relationships with key opinion leaders. Pharmosa will focus on advancing its sustained-release liposomal technology which has demonstrated in L606 the ability to dramatically reduce maximum systemic drug concentrations while significantly increasing local concentrations deep in the lung.”
Read the Liquidia Corporation press release.
