United Therapeutics Corp. is on a mission to make its pulmonary hypertension drug easier to take for many patients.
The Silver Spring biotech said a partner company has applied for premarket approval from federal regulators to allow patients to use United Therapeutics’ flagship injectable drug, Remodulin, with an implantable drug infusion system called SynchroMed II.
The system, developed by Minneapolis-based medical technology company MedTronic Inc. (NYSE: MDT), which submitted the premarket approval application, would allow patients to get the drug intravenously without the use of external pumps or infusion lines. The companies had been testing the two together in clinical trials for the past several years.
It’s a bid that industry experts say could make the United Therapeutics drug more competitive in a tough drug market. One analyst estimated late last year that such an implantable pump for Remodulin could generate upward of $200 million in peak sales for the local biotech, according to the Investor’s Business Daily.
United Therapeutics (NASDAQ: UTHR) said it plans to apply to the Food and Drug Administration in January to change Remodulin’s labeling to allow for its use with the SynchroMed II system.
