Shares in United Therapeutics (NSDQ:UTHR) fell -7% this morning to $126.17 apiece after the company said that the U.S. commercial launch of Remosynch, Medtronic‘s (NYSE:MDT) implantable infusion pump for Remodulin, will be delayed until 2018.
“United Therapeutics’ commitment to bringing better therapies to patients transcends temporary delays or setbacks,” United chairman & CEO Martine Rothblatt said in prepared remarks. “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.”
A spokesperson for Medtronic said that Remosynch’s delayed launch and the recall for Medtronic’s SynchroMed pump are not related. The spokesperson cited “complexities related to the parallel [regulatory] filings” as the reason for delaying the product’s launch, not the recall.*
Analysts are concerned that any delay in debuting an alternative delivery option for Remodulin will make it harder for United to protect its sales as it faces generic competition in the year ahead.
The FDA rejected Medtronic’s marketing application for a Remodulin drug pump last year.
In March, the FDA updated Medtronic’s Class I recall for the company’s SynchroMed II and EL implantable drug pumps over a priming bolus issue. which Medtronic said it can fix with a software update.
* Correction, April. 4, 2017: Updated April 4 to clarify that the delayed launch is not connected to Medtronic’s recall, according to a Medtronic spokesperson.↩