United Therapeutics and DEKA Sign Agreement for New PAH Remodulin Delivery System

United Therapeutics Corporation has signed an agreement with DEKA Research & Development Corp., to continue the development of a breakthrough technology for the subcutaneous delivery of the Remodulin (treprostinil) Injection. The device is expected to offer a potential treatment option for patients who suffer from pulmonary arterial hypertension (PAH) and improve administration of Remodulin.

The breakthrough subcutaneous delivery technology will operate via a pre-filled semi-disposable pump system, and the agreement between the companies to continue its development is in line with UT’s ongoing efforts to advance treatment for PAH.

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“The new DEKA semi-disposable pump system will advance the convenience and delivery of subcutaneous Remodulin,” explained Martine Rothblatt, Ph.D, Chairman and Co-CEO of United Therapeutics.  “In addition, it may bring the benefits of parenteral prostacyclin therapy to the thousands of PAH patients who are using the current delivery system or for those patients who no longer receive adequate benefit from oral and inhaled treatments.”

Remodulin is a prostacyclin vasodilator prescribed as a treatment for PAH patients in order to decrease symptoms related to exercise. Even though it can be administered as a continuous subcutaneous infusion or continuous intravenous infusion, there are several risks related to the use of chronic indwelling central venous catheters in delivering therapeutics, such as serious blood stream infections.

Physicians recommend that continuous intravenous infusion should only be an option for patients intolerant to the subcutaneous route, or in whom the risks are warranted. Given the need for an alternative continuous intravenous infusion, the new subcutaneous Remodulin delivery system, which is scheduled to be introduced between 2016 and 2018 according to United Therapeutics, will fill a major unmet need in PAH drug delivery. United Therapeutics and DEKA are now working in collaboration to improve the delivery of treatment to PAH patients, but additional details on the agreement were not announced.

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“We are pleased to advance the state of technology and engineering in subcutaneous drug delivery systems,” stated the President of DEKA, Dean Kamen.  “Our mastery of precision fluid dynamics, coupled with drug pre-filled in special modules, has enabled an unparalleled reduction in pump size for the benefit of patients.”

The medication has been evaluated in previous studies and has been proven effective, including in patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH, PAH associated with congenital systemic-to-pulmonary shunts, or PAH associated with connective tissue diseases. In addition, the drug may also be used by patients with PAH requiring transition from Flolan (epoprostenol sodium), in which Remodulin is administered for the reduction of the rate of clinical deterioration.

In addition, United Therapeutics Corporation recently announced that Medtronic, Inc., the world’s third largest medical device company, has forwarded a pre-market approval application to the U.S. Food and Drug Administration (FDA) for their proprietary SynchroMed® II implantable drug infusion system, along with a new catheter, to be used with Remodulin.