United Therapeutics (UTHR), Medtronic (MDT) Discontinue Efforts to Commercialize Implantable System for Remodulin

United Therapeutics (NASDAQ: UTHR) and Medtronic, Inc. (NYSE: MDT) agreed to discontinue further efforts to develop and commercialize the Implantable System for Remodulin (ISR).

By way of background, the ISR has been developed over the past 12 years in collaboration with Medtronic to deliver Remodulin (treprostinil) Injection for patients with pulmonary arterial hypertension (“PAH”) via an implantable system developed by Medtronic. On February 25, 2019, Medtronic and the Company entered into a Commercialization Agreement governing the parties’ collaboration to commercialize the ISR in the United States (the “Commercialization Agreement”). Despite approval by the U.S. Food and Drug Administration (“FDA”) of Medtronic’s premarket approval application (“PMA”) for the ISR in December 2017, commercial launch of the product required Medtronic, as the applicant, to satisfy certain conditions to its PMA approval. Based on the evolution of treatment options and paradigms in PAH over the past few years, and the anticipated efforts required to satisfy the FDA’s conditions of approval, the Company and Medtronic have decided to discontinue further efforts to develop and commercialize the ISR. The Company and Medtronic plan to work together on a mutually-agreed approach to wind-down the development program, and to support patients already enrolled in clinical studies of the ISR, at the Company’s sole expense.

Effective June 22, 2021, the parties mutually agreed to terminate the Commercialization Agreement. There were no penalties associated with the termination of the Commercialization Agreement.

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