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news.Actelion, a biopharmaceutical company, has entered into a definitive agreement to acquire an improved, thermostable formulation of epoprostenol sodium for the intravenous treatment of pulmonary arterial hypertension from GeneraMedix, a provider of injectable products.
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The FDA has previously approved this improved formulation of Epoprostenol for Injection (1.5mg/ml vial) for the long-term intravenous treatment of primary pulmonary hypertension and pulmonary hypertension associated with the scleroderma spectrum of disease in New York Heart Association 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.
According to the company, this improved formulation of intravenous epoprostenol uses non-proprietary diluents, and once reconstituted prior to use, it may be stored for up to 48 hours at 25ºC or for five days in the refrigerator at 2º to 8ºC.
Otto Schwarz, president of business operations at Actelion, said: Actelion has grown Tracleer into a cornerstone therapy in pulmonary arterial hypertension (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 US, followed later by other territories worldwide.