In this small proof of concept study, 8 GHD patients were given oral rhGH. Novartis investigated pharmacokinetics as well as the pharmacodynamic properties of the orally-delivered rhGH. The study showed that growth hormone peaks were recorded in all patients at some time points, although with considerable variability and minor endogenous growth hormone interference. An increase in IGF-I was seen in some patients, leading to a statistically significant increase in mean serum IGF-I at day 7 compared with end of wash-out.
"We are very excited about these results concerning the oral delivery of active rhGH using our technology," commented Michael M. Goldberg, M.D., Chairman and Chief Executive Officer of Emisphere. "We believe that this study is the first to show that such a large and complex protein can be delivered orally in humans in an active form. The positive results exemplify the utility of Emisphere's eligen® technology for the oral delivery of large proteins similar in size and complexity to rhGH. While much work remains in the optimization of the final product formulation, the results show that an elevation in IGF-I levels was obtained."
In April, Novartis Pharma AG notified Emisphere about its entitlement to a $5 million development commencement milestone payment as a result of Novartis' decision to proceed with product development. The payment of this development commencement milestone was the result of a license agreement executed by Emisphere and Novartis. Emisphere is entitled to receive additional milestones and royalties from Novartis should an oral growth hormone product be commercialized using Emisphere's eligen® technology.
In 2000, Emisphere and Novartis Pharma AG entered into a license agreement for the development of oral salmon 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 of 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 Recombinant Human Growth Hormone (rhGH)
Many children and adults suffer from growth hormone deficiency. Growth hormone is necessary to stimulate growth in children by promoting the growth of muscle and bone. In adults, growth hormone maintains muscle and bone quality. Recombinant human growth hormone (rhGH) has been available for several years but must be administered by injection. Prescribed dosing regimens range from three to seven injections per week, and may continue for several years. The annual sales of injectable growth hormone products are currently estimated at over $2.5 billion.
About the eligen® Technology
Emisphere's broad-based oral drug delivery technology platform, known as the eligen® technology, is based on the use of proprietary, synthetic chemical compounds, known as EMISPHERE® 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® 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 injectable drugs, either alone or with corporate partners, by applying its proprietary eligen® technology to those drugs or licensing its eligen® technology to partners who typically apply it directly to their marketed drugs. Emisphere's eligen® 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.
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.
Source: Emisphere Technologies, Inc.
