CEDAR KNOLLS, N.J., Feb. 20, 2009 (GLOBE NEWSWIRE) -- Emisphere Technologies, Inc. (Nasdaq:EMIS) announced results of a study indicating that orally administered salmon calcitonin using Emisphere's carrier, (5-CNAC) an Eligen(r) oral delivery technology, is effective in reducing bone breakdown. The study was conducted on behalf of Emisphere's partner Novartis Pharma AG by Nordic Bioscience, and published in BMC Clinical Pharmacology.
"We continue to be encouraged by the results of the oral calcitonin product using our Eligen(r) Technology," said Michael V. Novinski, President and Chief Executive Officer of Emisphere. Currently, Novartis has more than 4,400 subjects enrolled in a three-year Phase III trial, which began in February 2007, for the treatment of osteoporosis using Emisphere's oral delivery formulation.
This most recent study, a randomized, double-blind, double-dummy, placebo-controlled study among 81 subjects in Copenhagen, was conducted by M.A. Karsdal, I. Byrjalsen, B.J. Riis and C. Christiansen, and published in December 2008. The study suggests that orally administered 0.8 mg of salmon calcitonin was effective in suppression of Serum CTX irrespective of time of dosing. Serum CTX-1 (Serum C-terminal telo-peptide of collagen type I) is the biochemical marker used to measure bone resorption. There were no safety concerns with the salmon calcitonin oral formulation using Emisphere's carrier 5-CNAC, which had been previously demonstrated in earlier studies.
Osteoporosis is a disease associated with a gradual thinning and weakening of the bones, occurring most frequently in post-menopausal women. Thinner and weaker bones are increasingly susceptible to fractures as women age. Untreated postmenopausal osteoporosis can lead to chronic back pain, disabling fractures and lost mobility. Currently there are 10 million managed osteoporosis patients and 34 million additional individuals who are at risk for the condition.
About Emisphere Technologies, Inc.
Emisphere is a biopharmaceutical company that focuses on a unique and improved delivery of therapeutic molecules using its Eligen(r) Technology. These molecules and compounds could be currently available or in development. Such molecules are usually delivered by injection; in many cases, their benefits are limited due to poor bioavailability, slow on-set of action or variable absorption. The Eligen(r) Technology can be applied to the oral route of administration as well as other delivery pathways, such as buccal, rectal, inhalation, intra-vaginal or transdermal. The company's website is: 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 13, 2008 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2008, filed on August 11, 2008.