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Emisphere Technologies, Inc. Reports Clinical Data on Oral Delivery,of GLP-1 and PYY

the 4 mg oral dose of GLP-1 was 300 pMol/L.

In the PYY study, the drug was given orally to six healthy male subjects in a six way cross-over design. The treatment arms consisted of oral doses (0.25, 0.5, 1.0, 2.0 and 4.0 mg) of PYY with Emisphere's delivery agent administered as a single tablet versus placebo. The Cmax value of PYY for the 4 mg oral dose had a plasma concentration of 629 pg/ml. In addition, there was a reduction of Ghrelin in all groups administered PYY with the largest percent reduction in Ghrelin levels observed in the 4 mg PYY dose.

"This study showed for the first time that GLP-1 was active with regard to stimulation of insulin releases in humans after oral administration. In the subjects receiving the highest doses of oral GLP-1, we observed nausea effects similar to those seen when the subjects received high levels of injectable GLP-1. The biodynamic results on insulin release and blood concentrations indicate that oral GLP-1 could be an effective treatment in diabetes. The PYY results in combination with the GLP results could mean that oral PYY and oral GLP-1 could also be an effective treatment for other diseases such as obesity. We will seek to publish these results," said Dr. Christoph Beglinger of the University Hospital in Basel.

"We are very pleased to be working on the oral delivery of GLP-1 and PYY with a leading academic researcher such as Dr. Beglinger in the field of gastroenterology. The compounds GLP-1 and PYY are gastrointestinally produced hormones and GLP-1 is already an important compound in the treatment of diabetes as an injectable agent. Non-oral forms of these compounds are being explored in the treatment of obesity. We are looking forward in 2007 to initiating and completing a proof-of-concept efficacy study on the reduction of food intake using our oral incretin products with Dr. Beglinger," said Lewis H. Bender, President and CEO of Emisphere Technologies, Inc.

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