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Baxter Presents Phase I Inhaled Insulin Study Results at,Respiratory Drug Delivery Conference

Findings Suggest Insulin Powder Produced Using Baxter's PROMAXX Microsphere Technology was Absorbed Systemically with No Reported Cough or Shortness of Breath

PARIS, April 20, 2007 /PRNewswire-FirstCall/ -- Baxter Healthcare Corporation announced results of a Phase I study that evaluated pulmonary insulin produced with Baxter's PROMAXX microsphere technology and administered using a small, standard dry powder inhaler. Baxter presented the Phase I data earlier this week at the Respiratory Drug Delivery Europe 2007 Conference in Paris.

The study demonstrates that the insulin powder can be effectively administered to the deep lung using an off-the-shelf dry powder inhaler designed for upper airway drug delivery. A total of 30 subjects participated in the randomized, two-way crossover study conducted in Germany. Each subject received in randomized fashion a single dose of 10 International Units of insulin through subcutaneous injection (SC) in one period, and 6.5 milligrams of the inhaled insulin microspheres, called recombinant human insulin inhalation powder (RHIIP) in the other period.

RHIIP is made using Baxter's proprietary PROMAXX formulation technology. Unlike other dry powder formulations of insulin, RHIIP is 95 percent insulin and does not rely on the use of inactive ingredients to facilitate delivery to the deep lung. In this study, no serious adverse events were reported and no subjects withdrew from the study due to an adverse event. All adverse events were mild in severity. The most common reported treatment-emergent adverse event was phlebitis. There were no reported episodes of cough or shortness of breath in this study.

Study data show that RHIIP had a faster onset of action than SC (time to reach 10 percent of total area under the glucose infusion rate (GIR) curve 73 vs 95 min.; GIR-tmax 173 versus 218 min., p<0.0001). Duration of action (371 vs 366 min.) and total metabolic ef
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