Emisphere Announces Data From Independent Clinical Study Of Effects Of Oral GLP-1 On Glucose And Insulin Concentrations

Main Category: Diabetes
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 09 Jul 2008 - 1:00 PST

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Emisphere Technologies, Inc. (Nasdaq: EMIS) announced findings from a clinical study assessing the oral delivery of GLP-1 peptide safely and effectively. The study used a delivery-agent-based approach using Emisphere's Eligen(R) technology, and was conducted at University Hospital in Basel, Switzerland by Christoph Beglinger, M.D., of the Clinical Research Center, Department of Biomedicine Division of Gastroenterology, and Department of Clinical Pharmacology and Toxicology at the hospital.

Prof. Beglinger's study, conducted in 16 healthy male subjects, was designed to explore the pharmacodynamic effects of a single oral dose of GLP-1 administered 15 minutes prior to an oral glucose tolerance test.

For the study, GLP-1 was formulated as a tablet with Emisphere's delivery agent known as SNAC. This was Prof. Beglinger's second clinical study of the compound, and it confirmed his earlier results that SNAC allows for rapid oral absorption of GLP-1. Prof. Beglinger's study also showed that pharmacological levels were achieved after a 2 mg oral dose. The study demonstrated that the oral formulation of GLP-1 stimulated an early increase in fasting insulin and a decrease in fasting glucose as compared to placebo.

"An intravenous or subcutaneous application of GLP-1 is cumbersome and impractical for chronic treatment regimens. Oral application of peptides is, however, difficult as peptides have a low oral bioavailability due to their molecular size and physico-chemical characteristics," said Prof. Beglinger. "Emisphere's oral delivery approach has been developed to overcome some of these issues."

"Prof. Beglinger's study provides yet further evidence in the application of our Eligen(R) technology as a potential solution to critical hurdles in pharmaceutical development. Hopefully, its use with GLP-1 in the treatment of diabetes will improve healthcare for millions of patients," said Michael V. Novinski, President and Chief Executive Officer of Emisphere.

Emisphere's Eligen(R) technology is based on the development of small organic molecules, termed delivery agents or carriers, that interact non-covalently with macromolecules to enable their oral absorption. GLP-1 is rapidly absorbed after oral administration with SNAC. Emisphere announced on June 23, 2008 that it entered a Development and License Agreement with Novo Nordisk A/S focused on the development of oral formulations of Novo Nordisk's proprietary GLP-1 receptor agonists.

ABOUT EMISPHERE TECHNOLOGIES, INC.

Emisphere Technologies, Inc. is a biopharmaceutical company that focuses on a unique and improved delivery of therapeutic molecules and pharmaceutical compounds using its Eligen(R) Technology. Some of these molecules or compounds can only be given by injection; when combined with our technology; convenient oral versions may be safe, effective and provide significant advantages. The benefits of other compounds are limited due to poor bioavailability, slow on-set of action or variable absorption. In those cases, use of Emisphere's technology can improve the therapeutic effectiveness of the compounds. The Eligen(R) technology can be applied to the oral route of administration as well other delivery pathways. The Web site is: http://www.emisphere.com.

Safe Harbor Statement Regarding Forward-looking Statements

The statements in this release and oral statements made by representatives of Emisphere relating to matters that are not historical facts (including without limitation those regarding the timing or potential outcomes of research collaborations or clinical trials, any market that might develop for any of Emisphere's product candidates and the sufficiency of Emisphere's cash and other capital resources) are forward-looking statements that involve risks and uncertainties, including, but not limited to, the likelihood that future research will prove successful, the likelihood that any product in the research pipeline will receive regulatory approval in the United States or abroad, the ability of Emisphere and/or its partners to develop, manufacture and commercialize products using Emisphere's drug delivery technology, Emisphere's ability to fund such efforts with or without partners, and other risks and uncertainties detailed in Emisphere's filings with the Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in Emisphere's Annual Report on Form 10-K (file no. 1-10615) filed on March 17, 2008 and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2008, filed on May 7, 2008.

Emisphere Technologies, Inc.
http://www.emisphere.com