CEDAR KNOLLS, N.J., Nov. 24, 2008 (GLOBE NEWSWIRE) -- Emisphere Technologies, Inc. (Nasdaq:EMIS) announced today the results of a study by Novartis Pharma AG which demonstrates the achievement of a suitable PK profile of a new oral formulation of Parathyroid Hormone ("PTH") using Emisphere's Eligen(r) Technology. This initial study of 20 healthy postmenopausal female patients aged 40 to 70 years resulted in peak concentrations (CMAX) in the range of those obtained with the commercially available subcutaneous formulation Forteo (teriparatide). The plan is to continue the development program.
Recombinant PTH, currently approved for the treatment of osteoporosis, is available only by injection. PTH exists naturally in the body; it increases bone density and bone strength to help prevent fractures. It may also be used to treat osteoporosis in patients at high risk of bone fracture.
"As with the development of any drug, these study results were very critical. They may confirm the formulation and the technology and set the stage for an important development plan which will now follow," said Michael V. Novinski, President and Chief Executive Officer of Emisphere Technologies, Inc. "Oral PTH is a significant early-stage product to the Emisphere pipeline, albeit earlier stage."
This initial trial reported no significant adverse affects, no hypocalcaemia, and no drug-exposure related discontinuation.
Osteoporosis is a disease associated with a gradual thinning and weakening of the bones, occurring most frequently in women after menopause. Thinner and weaker bones are increasingly susceptible to fractures. Untreated postmenopausal osteoporosis can lead to chronic back pain, disabling fractures, and lost mobility.
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 other delivery pathways, such as buccal, rectal, inhalation, intra-vaginal or transdermal. The 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 September 30, 2008, filed on November 6, 2008.