TARRYTOWN, NY, April 12 /PRNewswire-FirstCall/ -- Emisphere Technologies, Inc. today announced that the U.S. Patent and Trademark Office has granted an additional patent to Emisphere regarding the pulmonary delivery of proteins, using Emisphere's eligen(R) technology. Emisphere received U.S. Patent number 6,991,798 with claims directed to the pulmonary delivery of peptides. In addition, foreign Patent Number 2001273153, granted in March, provides Emisphere with additional patent protection for pulmonary delivery of peptides. Thus far in 2006, three patents have been granted to Emisphere containing language and/or claims affording patent protection for the pulmonary delivery of proteins, bringing the total of U.S. patents owned by Emisphere to nine, with additional applications concerning pulmonary routes of administration in progress.
The Company also announced that it has generated promising preclinical data from studies conducted by Emisphere and its academic collaborators demonstrating that the bioavailability of insulin via pulmonary delivery with an eligen(R) carrier was approximately two fold higher than pulmonary dosing of insulin alone, and had a bioavailability greater than 70% when compared to subcutaneous dosing. The preclinical results demonstrated that the product showed rapid absorption kinetics with an onset of action (Tmax) in less than 5 minutes. Moreover, as described in a recently published article*, gene microarray analyses of mRNA showed that pulmonary delivery of insulin in combination with the Emisphere carrier reduces the up-regulation of immune response genes, potentially ameliorating certain concerns related to long term dosing of insulin to the lung.
"While we remain completely focused on developing oral forms of insulin using our eligen(R) technology, and look forward to our Phase 2 oral insulin results later this year, for those companies interested in improving the pulmonary delivery of insulin, Emisphere's eligen(R) technology could provide a unique advantage of high bioavailability with the potential to reduce the undesirable side effects from chronic administration of insulin to the lungs," said Michael M. Goldberg M.D., Chairman and CEO of Emisphere Technologies, Inc. "We believe our intellectual property in improved transport of proteins, such as insulin across biological membranes, including in the GI tract and lung, is quite broad. With the recent approval of a first generation product of inhaled insulin and the emerging clinical data base with second generation inhaled insulin formulations, Emisphere has a strong intellectual property estate in next generation pulmonary delivery using a system that has demonstrated activity and the potential to improve the safety profile over existing products with the added benefit of formulation flexibility as either a dry powder or liquid."
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 drugs that are not currently available or have poor bioavailability in oral form, 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 organics. 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 .
* "Response of the Lung to Pulmonary Insulin Dosing in the Rat Model and Effects of Changes in Formulation." T. Cooper Woods, Ph.D., Bin Zhang, M.S., Frank Mercogliano, B.S., and Steven M. Dinh, Sc.D. Diabetes Technology & Therapeutics, Volume 7, Number 3, 2005. 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 (the "SEC"), 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 16, 2006.
Emisphere Technologies, Inc.CONTACT: Investor Relations: Stewart Siskind of Emisphere Technologies,Inc. +1-914-785-4790, Info@Emisphere.com; Media: Dan Budwick of BMCCommunications, +1-212-477-9007 ext.14, for Emisphere Technologies
Web site: http://www.emisphere.com/
