Actelion announces acquisition of a new formulation of intravenous epoprostenol

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."

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