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Actelion announces acquisition of a new formulation of intravenous epoprostenol with improved thermal stability for the treatment of Pulmonary Arterial Hypertension


ALLSCHWIL/BASEL, SWITZERLAND - Actelion Ltd (SIX: ATLN) announced today it has entered into a definitive agreement to acquire an improved, thermostable formulation of epoprostenol sodium for the intravenous treatment of pulmonary arterial hypertension (PAH) from privately-held GeneraMedix Inc. (GXI). GeneraMedix specializes in injectable products for U.S. hospital and specialty markets and is located in Liberty Corner, New Jersey/United States.

On 27 June 2008, the United States Food and Drug Administration (FDA) approved this improved formulation of Epoprostenol for Injection (1.5 mg/ml vial) 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.

The formulation is protected by patent applications. Actelion will be responsible for worldwide development, registration and commercialization of the product. Financial details of the agreement are not disclosed.

This improved formulation of i.v. epoprostenol uses non-proprietary diluents, and once reconstituted prior to use, it may be stored for up to 48 hours at 25º C or for 5 days in the refrigerator at 2º to 8º C.

Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion commented: “We are very pleased to acquire this innovative product as it builds on our commitment to PAH therapy. Actelion has always led the drive for improving the lives of PAH patients and we believe this new improved formulation could potentially play a significant role in the management of PAH.”

Unlike other epoprostenol formulations approved for PAH, this unique formulation is stable at room temperature for up to 24 hours when diluted and filled into the pump for administration and so can be used without frozen gel packs.

Jean-Paul Clozel continued: “This feature may provide clear benefits with respect to its administration. It may allow PAH patients greater freedom and convenience. There could also be less drug wastage. We will work with patients and PAH specialists to further optimize the use of this new formulation.”

Otto Schwarz, President Business Operations, commented: “Actelion has grown Tracleer® into a cornerstone therapy in PAH. We are also committed to making further investments in developing innovative therapies for patients and their treating physicians. This thermostable formulation of epoprostenol addresses several limitations of conventional epoprostenol. We will work closely with PAH specialists to generate strong clinical experience with this product and to have a best-in-class product available for all PAH patients, first in the United States, followed later by other territories worldwide.”

Notes to the editor:

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.

About Tracleer® in Pulmonary Arterial Hypertension (PAH)
Tracleer® (bosentan), the first oral dual endothelin receptor antagonist, is approved for the treatment of pulmonary arterial hypertension (PAH) and made available by Actelion subsidiaries in the United States, the European Union, Japan, Australia, Canada, Switzerland and other markets worldwide.

Requires attention to two significant safety concerns: Potential for serious liver injury (including rare cases of liver failure and unexplained hepatic cirrhosis in a setting of close monitoring) - Liver monitoring of all patients is essential prior to initiation of treatment and monthly thereafter. Tracleer® treatment must not be initiated in women of childbearing potential unless they practice reliable contraception and participate in monthly pregnancy testing. Due to these risks, Tracleer® is only supplied through a controlled distribution.

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.
4. Tracleer® SPC.

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 1900 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® )

GeneraMedix, Inc.
GeneraMedix Inc. is a privately held pharmaceutical company specializing in difficult to develop and/or manufacture injectable products for the U.S. hospital and specialty markets. In addition to its marketed products, GeneraMedix has a significant number of injectable products under development, as well as a number of products currently under FDA review. Headquartered in Liberty Corner, New Jersey, the company was founded in July of 2004, with equity partners GTCR Golder Rauner, LLC, and Ferrer Freeman & Company, LLC. Additional information is available on the company’s website at


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