Actelion Pharmaceuticals launches Epoprostenol for Injection for treatment of primary pulmonary hypertension

Apr 22 2010

Actelion Pharmaceuticals US, Inc. today announced the commercial availability of Epoprostenol for Injection, an improved formulation of epoprostenol that is stable at room temperature, for the treatment of primary pulmonary hypertension and pulmonary hypertension associated with scleroderma spectrum of disease in NYHA Class III and Class IV patients. Simultaneously, the company has launched the PROSPECT registry, a multicenter, observational, U.S.-based registry that will provide additional clinical experience on patients being treated with Epoprostenol for Injection.

Epoprostenol for Injection is a therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe PAH. Unlike other epoprostenol formulations, Epoprostenol for Injection is stable at room temperature for up to 24 hours when diluted and put into the pump for administration, eliminating the need for ice packs.

Accredo Health Group, Inc., a wholly-owned subsidiary of Medco Health Solutions, Inc., will serve as the sole specialty pharmacy provider of Epoprostenol for Injection.  Accredo brings years of experience in treating epoprostenol patients and a team of specialist nurses and pharmacists with extensive PAH training.

"The launch of Epoprostenol for Injection provides patients with a proven therapy that is a convenient treatment option," said Shal Jacobovitz, president of Actelion Pharmaceuticals US, Inc. "We are proud of our portfolio of PAH therapies and continue our commitment to deliver a wide range of  therapies to PAH patients. Tracleer® (bosentan) is the market leading oral therapy in PAH, Ventavis® (iloprost) continues to be the leading inhaled prostacyclin, and Epoprostenol for Injection is the first epoprostenol formulation that is stable at room temperature up to 24 hours."

"Patients with late-stage PAH are extremely ill and have little energy, so a therapy that is convenient could make a big difference in their daily lives," said Vallerie McLaughlin, M.D., Professor and Director of the Pulmonary Hypertension Program at the University of Michigan. "In addition, the PROSPECT registry will be valuable in enhancing our understanding of patient response to Epoprostenol for Injection, and will help physicians provide the most appropriate care to patients."

Accredo President Steven R. Fitzpatrick added, "This is an exciting improvement for people with moderate to severe PAH, and we are pleased to assist patients in the administration and follow up care for this important therapy."