Treprostinil Infusion Pump for PAH Is Goal of New Collaboration
3 companies team up on new way to deliver Remodulin generic
Liquidia and Sandoz will collaborate with Mainbridge Health Partners to develop a new subcutaneous or under-the-skin infusion pump for treprostinil — a generic form of Remodulin — for treating people with pulmonary arterial hypertension (PAH).
The exclusive rights to promote and market treprostinil injection belong to Liquidia together with Sandoz — with that agreement now extended to 2032.
“Our goal is to ensure the widespread availability of our trusted and proven Treprostinil Injection to the benefit of physicians, payors and patients in the PAH community,” Scott Moomaw, senior vice president of commercial at Liquidia, said in a company press release.
Companies developing new under-the-skin infusion pump
PAH is characterized by the narrowing of the pulmonary arteries, restricting blood flow across the lungs. This causes high blood pressure and makes the heart work harder to pump blood to the body.
Treprostinil is a man-made form of the hormone prostacyclin, which relaxes and widens blood vessels, thereby lowering blood pressure. It is commercialized as Remodulin by United Therapeutics, administered by continuous delivery under the skin or into the vein using the CADD-MS 3 infusion pump.
Now, Liquidia and Sandoz are teaming up with Mainbridge to develop a new infusion pump to deliver treprostinil subcutaneously. The device’s development will be funded equally by the two original collaborators, with Mainbridge responsible for developing, validating, and testing the pump and related consumables.
“To alleviate the single-source dependence on the existing CADD-MS 3 system, Sandoz and Liquidia have found a great partner in Mainbridge with the skills and know-how to efficiently develop a new infusion pump using technology that has been previously approved by the U.S. Food and Drug Administration (FDA) for delivery of insulin,” Moomaw said.
The parties anticipate submitting the device for approval in 2023 under the FDA 510(k) clearance. This procedure allows developers to demonstrate that a medical device to be marketed is as safe and effective as a legally marketed device.
In connection with the development of the device, Liquidia and Sandoz also decided to extend their promotion agreement on treprostinil injection until the end of 2032.
Liquidia also is developing an inhaled dry powder formulation of treprostinil, called Yutrepia, which is delivered through a palm-size device. Yutrepia was granted tentative approval by the FDA in 2021 and is indicated for improving exercise ability in PAH adults with slight to marked limitations in activity.
According to Moomaw, “Liquidia remains committed to addressing unmet needs in the administration of treprostinil, whether it be inhaled or infused.”