Liquidia gets $50M more after first sale of Yutrepia to treat PH
Company's treprostinil formulation had been focus of US court battle
Following the first commercial sale of Yutrepia (treprostinil) inhalation powder to treat certain types of pulmonary hypertension, the therapy’s maker, Liquidia, has received an additional $50 million under its financing agreement with Healthcare Royalty (HCRx).
Per that HCR Agreement, Liquidia has been raising funds by selling HCRx a percentage of future revenue generated from drug sales. This type of agreement enables a company to raise capital without issuing equity.
“We are grateful for the continued partnership with HCRx and pleased with the early stages of Yutrepia’s launch,” Michael Kaseta, Liquidia’s chief financial officer and chief operating officer, said in a company press release. “The proceeds from HCRx will further accelerate our launch execution, advance our clinical pipeline, and support the expansion of future manufacturing operations, including the buildout of our newly leased manufacturing facility.”
According to Kaseta, Liquida’s “early momentum and strong financial position reinforce our belief in Liquidia’s ability to achieve profitability without the need for additional capital.”
HCRx’s additional payment to Liquidia followed a decision by the U.S. District Court for the Middle District of North Carolina, which denied pharmaceutical maker United Therapeutics’ request for a preliminary injunction and temporary restraining order in its complaint against Liquidia. United alleged that Yutrepia would infringe on its patents for Tyvaso DPI — its inhaled dry powder formulation of treprostinil first approved in the U.S. in 2009.
In late May, the U.S. Food and Drug Administration approved Yutrepia as a treatment for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). Both are types of pulmonary hypertension, characterized by abnormally high blood pressure in the vessels that carry blood through the lungs.
Developed using Liquidia’s PRINT technology, Yutrepia is an inhaled dry powder formulation of treprostinil, a medicine that’s designed to mimic prostacyclin, a naturally occurring hormone. It reduces blood pressure by relaxing and widening blood vessels.
Soon after Yutrepia was approved, Liquidia scheduled its first commercial shipment to specialty pharmacies in the U.S.
Yutrepia payment from HCRx will help advance new drug formulation
To date, Liquidia has secured $175 million of the $200 million in total potential funding, per the release. An additional $25 million remains available if Liquidia achieves net sales of Yutrepia over $100 million at any time on or before June 30, 2026. The extra $50 million paid by HCRx is subject to a fixed payment schedule through 2033.
“[This] news reflects an important milestone in Liquidia’s commercial execution of Yutrepia and further strengthens our confidence in the company’s long-term vision,” said Clarke Futch, chairman and CEO of HCRx. “We are pleased to support Liquidia as it further advances the commercial launch of Yutrepia and prepares to expand future manufacturing capabilities to meet growing market demand in the years ahead.”
We are pleased to support Liquidia as it further advances the commercial launch of Yutrepia and prepares to expand future manufacturing capabilities to meet growing market demand in the years ahead.
The new funds will also support the development of L606, a next-generation sustained-release formulation of inhaled treprostinil, according to Liquidia.
Developed in partnership with Pharmosa Biopharm, L606 is comprised of treprostinil encapsulated within liposomes, or tiny, fat-like particles. It’s given twice daily using a handheld nebulizer similar to those used with dry-powder treatments. The slow-release formulation allows for more sustained drug exposure in the lungs and less frequent dosing — twice daily versus four times daily with Tyvaso.
In a previous Phase 1 study (NCT04041648) in healthy adults, the treatment resulted in therapeutic levels of L606 in the bloodstream for up to 12 hours, with peak levels seven times lower than those of Tyvaso, the company reported.
L606 is now undergoing testing in a Liquidia-sponsored open-label Phase 3 clinical trial (NCT04691154) that enrolled 28 adults with PAH and PH-ILD at five sites across the U.S.
In the trial’s first part, L606 doses of up to 360 micrograms (mcg) twice daily, equivalent to 25 or more breaths of Tyvaso four times per day, were generally well tolerated in adults with PAH or PH-ILD who had been using Tyvaso. Common side effects included cough, shortness of breath, dizziness, and blurred vision. In its second part, L606 will be assessed in a separate group, among patients whom the study investigators believe are likely to benefit from inhaled treprostinil.
About the Author
