United Therapeutics (UTHR) to Postpone Launch of Remosynch Implantable Pump Amid Regulatory Delay

April 3, 2017 6:01 AM EDT

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United Therapeutics Corporation (NASDAQ: UTHR) announced that regulatory delays will result in postponement of the planned U.S. launch of the RemoSynch™ Implantable System for Remodulin® until 2018.

"United Therapeutics' commitment to bringing better therapies to patients transcends temporary delays or setbacks," said Martine Rothblatt, Ph.D., United Therapeutics' Chairman and Chief Executive Officer. "We are sorry to have missed our 2017 launch target, but it is a small miss in the context of our providing more U.S. pulmonary arterial hypertension patients with helpful medicines than any other company."

United Therapeutics has been working with Medtronic, Inc. to develop Medtronic's proprietary intravascular infusion catheter to be used with Medtronic's implantable infusion pump and related infusion system components (together referred to as the Implantable System for Remodulin, or RemoSynch) for the delivery of Remodulin to treat patients with pulmonary arterial hypertension. In order to launch RemoSynch in the United States, Medtronic and United Therapeutics have been pursuing parallel regulatory filings relating to the device and the drug, respectively.

Conference Call

We will host a half-hour teleconference on Monday, April 3, 2017, at 9:00 a.m. Eastern Time to discuss the delayed launch of the RemoSynch Implantable System for Remodulin. The teleconference is accessible by dialing 1-877-351-5881, with international callers dialing 1-970-315-0533. A rebroadcast of the teleconference will be available for one week by dialing 1-855-859-2056, with international callers dialing 1-404-537-3406, and using access code: 2348311.

This teleconference is also being webcast and can be accessed via our website at http://ir.unither.com/events.cfm.

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