United Therapeutics Announces Collaboration With Ascendis Pharma To Develop Self-Injectable Treprostinil For Pulmonary Arterial Hypertension

About Ascendis Pharma and TransCon

Ascendis Pharma A/S is an emerging specialty pharmaceutical company which creates improved, patentable versions of marketed drugs.  The company is headquartered in Palo Alto, California and Copenhagen, Denmark, with research in Heidelberg, Germany.

Ascendis Pharma's prodrug technology platform, TransCon, is a proprietary technology enabling transient conjugation of peptides, proteins and small molecules to various carriers.  The technology utilizes Ascendis Pharma's proprietary TransCon Linker families, which are a diverse group of structures with inherent self-cleaving properties, making drug release independent of enzyme activity and tissue conditions. Ascendis Pharma's transient conjugation is designed to release drug in the body in a precise, time-controlled fashion, thus creating a long-acting effect for the original unmodified drug.

About Remodulin (treprostinil) Injection

Indication


Remodulin is a prostacyclin vasodilator indicated in the United States for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to diminish symptoms associated with exercise.  Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%).  Remodulin may be administered as a continuous subcutaneous infusion or continuous intravenous infusion; however, because of the risks associated with chronic indwelling central venous catheters, including serious blood stream infections, continuous intravenous infusion should be reserved for patients who are intolerant of the subcutaneous route, or in whom these risks are considered warranted. 

In patients with PAH requiring transition from Flolan® (epoprostenol sodium), Remodulin is indicated to diminish the rate of clinical deterioration.  The risks and benefits of each drug should be carefully considered prior to transition.

Important Safety Information


Chronic intravenous infusions of Remodulin are delivered using an indwelling central venous catheter.  This route is associated with the risk of blood stream infections, or BSI, and sepsis, which may be fatal.  Therefore, continuous subcutaneous infusion is the preferred mode of administration.

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