A majority of the patients who die of PAH in the United States each year have not
initiated treatment with an infused prostacyclin analogue, which is a complex and
burdensome form of medical therapy. In 2009, we entered into an agreement with Medtronic,
Inc. (Medtronic) to develop its Synchromed® implantable pump to deliver Remodulin,
which, if successful, could eliminate many of the patient burdens associated with
Medtronic commenced a clinical trial administering Remodulin using the Synchromed
in April 2011 to support FDA approval for the use of Remodulin® with its implantable
pump. Patient enrollment in the clinical trial was completed in late November 2012.
Based on current projections of patient days and discontinuations, we expect that
the clinical trial will be completed in late 2013. In certain countries in Europe,
an implantable pump distributed by OMT GmbH & Co. KG is used to deliver intravenous
Remodulin to some patients.