United Therapeutics Corporation’s UTHR revealed though an 8-K filing that it was informed (Mar 15, 2016) by its partner Medtronic plc MDT that the FDA had issued a response letter to Medtronic’s premarket approval application (PMA) seeking approval for the Remodulin Implantable System. Shares of United Therapeutics tanked 10.5% on the news.
In the response letter, the FDA raised concerns and asked Medtronic to take several measures to get the PMA approved. Currently, along with Medtronic, the company is evaluating the response letter and specified measures to address concerns raised by the regulatory agency.
Meanwhile, United Therapeutics continues to expect FDA action in Oct 2016 on its New Drug Application (NDA) seeking approval to allow the use of Remodulin with the Remodulin Implantable System.
We note that United Therapeutics’ efforts to bring Remodulin in the form of an implantable pump system to markets have been far from smooth. It faced a setback in Mar 2015 when the FDA asked Medtronic to amend its PMA for the Remodulin Implantable System to reflect an amendment to the SynchroMed II PMA that was separately submitted by Medtronic's neuromodulation business unit. Also, in the same month, the regulatory agency issued a refuse-to-file letter for the company’s NDA for the Remodulin Implantable System. Moreover, in April, the FDA filed a consent decree for Medtronic’s SynchroMed II drug infusion system.
The latest development on the regulatory front is evidently another setback for United Therapeutics. Both the NDA and PMA must be approved in order to launch the Remodulin Implantable System in the U.S.
United Therapeutics’ lead product, Remodulin, approved in the injectable form for the treatment of pulmonary arterial hypertension, recorded sales of $572.8 million in 2015, reflecting a 3% improvement. The product accounted for 39.1% of total sales in 2015. An approval of Remodulin in the form of implantable pump would expand its patient population and boost the commercial potential of the product.
Meanwhile, United Therapeutics is also working with DEKA Research & Development Corp. for the development of a pre-filled, semi-disposable pump system for the subcutaneous delivery of Remodulin. An approval in the U.S. is anticipated by the end of 2018.
United Therapeutics is a Zacks Rank #3 (Hold) stock. A couple of better-ranked stocks in the health care sector are Actelion Ltd. ALIOF and Sucampo Pharmaceuticals, Inc. SCMP, both sporting a Zacks Rank #1 (Strong Buy).
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