TARRYTOWN, N.Y., May 25 /PRNewswire-FirstCall/ -- Emisphere Technologies, Inc. announced today that Novartis Pharma AG has notified Emisphere that Novartis Pharma AG has completed the planned preclinical safety studies for the oral calcitonin product using Emisphere’s eligen(R) delivery technology.
In a recently finalized report, Novartis has concluded that oral administration of the eligen(R) delivery agent administered by gavage to rats for 104 weeks is not considered carcinogenic at doses up to 750 mg per kilogram per day. The carcinogenicity report would be submitted to the U.S. Food and Drug Administration (FDA) in any New Drug Application (NDA) submission on oral formulations of those molecules for which Novartis has obtained rights to use the Emisphere technology including calcitonin.
“We are very pleased that Novartis has generated significant safety data on our technology for its various programs,” commented Michael M. Goldberg, M.D., Chairman and Chief Executive Officer of Emisphere. “It is a major milestone for our technology that Novartis has now conducted all the necessary preclinical safety/toxicology studies over the past seven years required for the NDA submission on oral calcitonin, a chronically administered product.” In 2000, Emisphere and Novartis entered into a license agreement for the development of oral calcitonin for the treatment of osteoporosis; in 2004, the two companies entered into a license agreement for the development of oral human growth hormone. In March 2006, the two companies entered into a license agreement for the development of an oral form of parathyroid hormone (PTH) fragment 1-34 following a January 2006 ruling by a U.S. Federal Court that Eli Lilly had breached its agreements on PTH with Emisphere.
About Calcitonin
Calcitonin is a hormone known to participate in calcium and phosphorus metabolism. In mammals, the major source of calcitonin is from the parafollicular or C cells in the thyroid gland, but it is also synthesized in a wide variety of other tissues, including the lung and intestinal tract. In birds, fish and amphibians, calcitonin is secreted from the ultimobrachial glands. Calcitonin is a 32 amino acid peptide cleaved from a larger prohormone. Calcitonin is marketed as a nasal spray and injectable product. In 2005, sales were approximately $400 million.
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. Emisphere’s eligen(R) technology makes it possible to orally deliver a therapeutic molecule without altering its chemical form or biological integrity.
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 heparin, insulin, salmon calcitonin, 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 our web site, 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 16, 2006.
Emisphere Technologies, Inc.
CONTACT: Investor Relations: Emisphere Technologies, Inc.,+1-914-785-4742, Info@Emisphere.com; Media: Dan Budwick of BMCCommunications for Emisphere Technologies, Inc., +1-212-477-9007 ext. 14
Web site: http://www.emisphere.com/
