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Emisphere Technologies Completes Dosing in Heparin Clinical Trial

Posted on: Monday, 19 September 2005, 09:00 CDT

TARRYTOWN, N.Y., Sept. 19 /PRNewswire-FirstCall/ -- Emisphere Technologies, Inc. today announced that it has completed dosing all arms of a clinical trial to compare heparin delivered by intravenous and subcutaneous injection to Emisphere's oral heparin capsule formulation, which uses the eligen(R) technology. The purpose of the study is to demonstrate that heparin delivered by the oral route by means of the eligen(R) technology remains unaltered and has the same molecular composition as heparin administered by the subcutaneous or intravenous routes of administration. Previous studies have shown that Emisphere's oral heparin formulation can affect the coagulation cascade in a manner similar to injectable heparin. Should the results from the study be positive, the data could support a claim that heparin is unchanged by the oral route of administration using the Emisphere technology. Emisphere is working to characterize the heparin in the human plasma with Shaker A. Mousa, Ph.D., MBA, FACC, FACB, Director of the Pharmaceutical Research Institute at the Albany College of Pharmacy, and Robert Linhardt, Ph.D., the Constellation Professor of Biocatalysis and Metabolic Engineering at the Rensselaer Polytechnic Institute and Adjunct Professor at the Albany College of Pharmacy.

"The preliminary results of the anticoagulant parameters we have seen to date from the study are as expected," said Michael M. Goldberg, M.D. "The increase in activated partial thromboplastin time (APTT), a key measure of anticoagulant activity, in all subjects who received our oral product is consistent with our previous results, and we believe it could translate into a clinically meaningful effect. We look forward to obtaining the results from the molecular characterization work being conducted by our leading academic experts - Drs. Mousa and Linhardt. We hope to present the final results to the U.S. Food and Drug Administration (FDA) as soon as possible."

"To confirm that heparin dosed intravenously or subcutaneously has the same molecular composition as heparin dosed by the oral route utilizing the eligen(R) technology, an extraction process, similar to that described in the literature (Toida, Edens, Linhardt), followed by several analytical processes, which have been discussed with the FDA, will be used on the human plasma collected. We have evaluated the technique with human plasma from a previous Emisphere clinical trial with the oral Heparin/SNAC product," said Dr. Linhardt. Dr. Mousa added, "Levels of anti-Xa, anti-IIa and tissue factor pathway inhibitor of the subjects will be measured for all study arms allowing Emisphere to confirm that the key pharmacodynamic parameters of heparin, when given by the various routes of administration, are consistent. The results will potentially validate that heparin is unchanged when taken orally in a dosage form utilizing Emisphere's eligen(R) technology."

About the eligen(R) Technology

Emisphere's broad-based oral drug delivery technology platform, known as the eligen(R) technology, is based on the use of proprietary, synthetic chemical compounds, known as Emisphere(R) delivery agents, or "carriers." These molecules facilitate or enable the transport of the therapeutic macromolecules across biological membranes such as those of the gastrointestinal tract, and exert their desired pharmacological effect. The Emisphere(R) delivery agents have no known pharmacological activity themselves. Emisphere's eligen(R) technology makes it possible to orally deliver a therapeutic molecule without altering its chemical form or biological integrity. Emisphere is pursuing shortened registration timelines for currently marketed drug products whose absorption following oral administration is improved using the eligen(R) technology through supplemental New Drug Applications or 505(b)(2) filings with the US FDA. Successful achievement of these regulatory strategies may not require large-scale studies to support product registration.

About Emisphere Technologies, Inc.

Emisphere Technologies, Inc. is a biopharmaceutical company pioneering the oral delivery of otherwise injectable drugs. Emisphere's business strategy is to develop oral forms of injectable drugs, either alone or with corporate partners, by applying its proprietary eligen(R) technology to those drugs or licensing its eligen(R) technology to partners who typically apply it directly to their marketed drugs. Emisphere's eligen(R) technology has enabled the oral delivery of proteins, peptides, macromolecules and charged small organic molecules. Emisphere and its partners have advanced oral formulations or prototypes of salmon calcitonin, heparin, insulin, parathyroid hormone, human growth hormone and cromolyn sodium into clinical trials. Emisphere has strategic alliances with world-leading pharmaceutical companies. For further information, please visit 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 11, 2005.

Emisphere Technologies, Inc.

CONTACT: AT EMISPHERE TECHNOLOGIES, INC. - Elliot Maza, Chief FinancialOfficer, +1-914-785-4703; Gillian Racine, Investor Relations, +1-914-785-4742,gracine@emisphere.com; Dan Budwick, Media, BMC Communications,+1-212-477-9007, ext. 14

Web site: http://www.emisphere.com/

Source: PRNewswire-FirstCall

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