This excerpt taken from the UTHR 10-K filed Feb 27, 2006.
Item 1ARisk FactorsWe have limited experience with manufacturing and depend on third parties, who may not perform, to synthesize and manufacture many of our products.)
Many drug companies engage in research and development to commercialize products to treat cardiovascular, cancer and infectious diseases. We are aware of four existing treatments already approved in the United States for pulmonary arterial hypertension with which Remodulin competes. They are: Flolan, an intravenously delivered prostacyclin marketed by GlaxoSmithKline, PLC; Tracleer, an oral endothelin antagonist marketed by Actelion, Ltd.; Revatio®, a PDE-5 inhibitor and a new formulation of the very successful drug Viagra®, marketed by Pfizer; and Ventavis®, an inhaled prostacyclin marketed by CoTherix, Inc. in the United States and by Schering A.G. in Europe. Two additional oral endothelin antagonists are being developed. One is Thelin, being developed by Encysive Pharmaceuticals, Inc., and
the other is ambrisentan, being developed by Myogen, Inc. In addition, competitors may develop and commercialize other products that compete with our products and may do so more rapidly than us. (For further discussion on this risk, see