Date: 2012-09-20
Type of information: Development agreement
Compound: self-injectable Remodulin® (treprostinil)
Company: United Therapeutics (USA) Ascendis Pharma (Denmark-USA)
Therapeutic area: Rare diseases - Cardiovascular diseases - Autoimmune diseases
Type agreement: development
Action mechanism: 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%).
Disease: pulmonary arterial hypertension
Details: United Therapeutics has signed an exclusive agreement with Ascendis Pharma A/S to apply Ascendis Pharma\'s proprietary TransCon technology platform to United Therapeutics' treprostinil molecule, the active ingredient in Remodulin® (treprostinil) injection. United Therapeutics believes that the TransCon technology platform may enable a controlled, long-acting release of a novel, carrier-linked product, significantly enhancing the delivery profile of treprostinil by establishing a self-injectable alternative for patients who currently use the drug via a continuous infusion pump for the treatment of pulmonary arterial hypertension (PAH).
Under the terms of the agreement, United Therapeutics will also have exclusive rights to develop prostacyclin, prostacyclin analog and prostacyclin-related products for treatment of PAH using the TransCon technology, and will hold worldwide commercial rights to products resulting from the collaboration.
Financial terms:
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