Liquidia licenses rights in North America to inhaled L606 for PH
Company to pay $10M upfront for novel formulation of treprostinil
Liquidia has licensed the rights in North America to L606, a novel inhaled formulation of treprostinil that’s being tested in trials of people with pulmonary arterial hypertension (PAH) or pulmonary hypertension associated with interstitial lung disease (PH-ILD).
“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,” Roger Jeffs, Liquidia’s CEO, said in a company press release.
Under the agreement with L606’s developer, Pharmosa Biopharm, Liquidia will be responsible for developing the therapy, as well as handling regulatory requirements and commercialization, in the U.S. and Canada. Pharmosa will continue to manufacture L606, and the two companies will collaborate to make a redundant global supply chain.
Pharmosa will receive an upfront payment of $10 million in the deal, with the potential for additional payments and royalties if development milestones are met.
“Liquidia is the ideal partner to bring L606 to the North American market,” said Pei Kan, PhD, president of Pharmosa, adding, “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.”
Liquidia also preparing for potential launch of Yutrepia
Treprostinil is a vasodilator — a medication that prompts blood vessels to relax and widen, thereby lowering blood pressure. It is the active agent in Tyvaso, an approved inhalation therapy for PAH.
Liquidia has developed a dry powder inhalation formulation of treprostinil, branded as Yutrepia, which was given tentative approval by the U.S. Food and Drug Administration in 2021. Tentative approval means that the therapy has met regulatory requirements for approval. However, the treatment can not be brought to market due to ongoing litigation between Liquidia and Tyvaso’s maker, United Therapeutics. United had sued Liquidia, alleging that Yutrepia’s formulation infringed on its patents. For its part, Liquidia indicated earlier this year that it expected to resolve that legal battle by mid-2024.
“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,” Jeffs said.
L606 is a sustained-release formulation of inhaled treprostinil, designed for twice-daily dosing with a next-generation nebulizer. Pharmosa is sponsoring an open-label Phase 3 clinical trial (NCT04691154) testing the therapy in adults with PAH or PH-ILD. Recruitment is ongoing at sites in the U.S.
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.
“Pharmosa’s novel liposomal formulation offers potential to improve patient convenience and compliance with twice-daily dosing using a short-duration, next-generation nebulizer,” Jeff said.
“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,” Jeffs said.
Kan added that the therapy showed “the ability to dramatically reduce maximum systemic drug concentrations while significantly increasing local concentrations deep in the lung.”
With the license for L606 secured, Liquidia now is planning to pursue approval of this new formulation in the U.S. The company said it plans to submit an application based on data from the ongoing Phase 3 trial, as well as earlier Phase 1 data and another study comparing L606 against a placebo in people with PH-ILD. Liquidia expects to launch that application in early 2024.