Actelion Pharmaceuticals Announces Commercial Availability of Epoprostenol for Injection for the Treatment of Pulmonary Arterial Hypertension

SOUTH SAN FRANCISCO, Calif., April 22 /PRNewswire/ -- 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."

About Epoprostenol for Injection

Epoprostenol for Injection is indicated for the long-term intravenous treatment of primary pulmonary hypertension and pulmonary hypertension associated with the scleroderma spectrum of disease in NYHA Class III and Class IV patients who do not respond adequately to conventional therapy. Unlike other epoprostenol formulations approved for PAH, this formulation is stable at room temperature (77 F, 25 C), for up to 24 hours after it has been diluted and administered, making the use of frozen gel packs unnecessary. Epoprostenol for Injection can be reconstituted with either Sterile Water for Injection, USP, or Sodium Chloride 0.9% Injection, USP, eliminating the need for drug-specific diluents.

More information is available at www.epoprostenol.com.

About the PROSPECT Registry

PROSPECT, the registry to PROSPECTively evaluate use of Epoprostenol for Injection in patients with pulmonary arterial hypertension, is a multicenter, observational, U.S.-based registry. PROSPECT is designed to provide information about the demographics and disease characteristics of patients who are initiating or currently receive Epoprostenol for Injection. Dosing regimens and titration scheme Epoprostenol for Injection will also be characterized through the registry. PROSPECT is expected to enroll approximately 300 patients at up to 60 U.S. centers. Patient enrollment is expected to begin in the second quarter of 2010 and continue through the second quarter of 2011.  Patients will be followed for up to one year, and data will be collected quarterly.

About Pulmonary Arterial Hypertension (PAH)

Pulmonary arterial hypertension (PAH) is a chronic, life-threatening disorder characterized by abnormally high blood pressure in the arteries between the heart and lungs of an affected individual. The function of the heart and lungs is severely compromised, manifested by a limited exercise capacity, and, ultimately, a reduced life expectancy. Approximately 100,000 people in Europe and the United States are afflicted with either primary or secondary forms of the disease related to conditions or tissue disorders that affect the lungs, such as scleroderma, lupus, HIV/AIDS or congenital heart disease.

PAH is associated with structural changes in both the pulmonary vasculature and the right ventricle. Recent advances [1] in the understanding of the pathogenic factors leading to the pulmonary vascular disease have led to the development of new therapies targeting specific pathways (the prostacyclin pathway; the endothelin pathway; and the nitric oxide pathway) [2]. The available therapies have positive effects in PAH, but they do not provide a cure, and in many patients the disease will progress. PAH remains a serious life-threatening condition [2,3]. Early recognition and an understanding of the selection and timing of therapeutic options remain critical elements in the optimal management of patients with this disorder.

References

1. Farber HW; Loscalzo J. Mechanisms of disease: pulmonary arterial hypertension. N. Eng. J. Med. 2004; 351:1655-65.
2. Humbert M; Sitbon O; Simonneau G. Treatment of pulmonary arterial hypertension. N. Eng. J. Med. 2004;351:1425-36.
3. Humbert M; Morrell NW; Archer SL; et al. Cellular and molecular pathobiology of pulmonary arterial hypertension. J. Am. Coll. Cardiol. 2004; 43: Suppl. 12: 13S-24S.

Actelion Ltd

Actelion Ltd is a biopharmaceutical company with its corporate headquarters in Allschwil/Basel, Switzerland. Actelion's first drug Tracleer®, an orally available dual endothelin receptor antagonist, has been approved as a therapy for pulmonary arterial hypertension. Actelion markets Tracleer® through its own subsidiaries in key markets worldwide, including the United States (based in South San Francisco), the European Union, Japan, Canada, Australia and Switzerland. Actelion, founded in late 1997, is a leading player in innovative science related to the endothelium - the single layer of cells separating every blood vessel from the blood stream. Actelion's over 2000 employees focus on the discovery, development and marketing of innovative drugs for significant unmet medical needs. Actelion shares are traded on the SIX Swiss Exchange (ticker symbol: ATLN) as part of the Swiss blue-chip index SMI (Swiss Market Index SMI®).

SOURCE Actelion Pharmaceuticals US, Inc.

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