TARRYTOWN, N.Y., March 8 /PRNewswire-FirstCall/ -- Emisphere Technologies, Inc. (“Emisphere”) announced today that Novartis has executed its license option for the development and commercialization of an oral parathyroid hormone (PTH) using Emisphere’s eligen(R) delivery technology. Emisphere is eligible for milestone payments totaling up to a maximum of $30 million, plus royalties on sales of the product.
“We are very pleased that Novartis has indeed elected to execute its option to develop oral dosage forms of PTH using our technology,” commented Michael M. Goldberg, M.D., Chairman and Chief Executive Officer of Emisphere. “The overwhelmingly favorable decision by the court in our litigation with Lilly will now mean that this product can at last move forward with a committed and capable partner.”
This license agreement marks the third between the two companies: In 2000, Emisphere and Novartis entered into a license agreement for the development of oral salmon calcitonin, and a second agreement followed in 2004, for the development of oral human growth hormone.
The decision to execute the license follows the January 6, 2006, U.S. Federal Court decision in Indianapolis favoring Emisphere in its litigation with Eli Lilly and Company (“Lilly”). The Court agreed with Emisphere that Lilly had indeed breached the agreement in multiple areas and that the PTH agreement between Lilly and Emisphere was indeed terminated.
In exchange for the option right, Emisphere received from Novartis in 2004, $10 million in the form of a convertible note. Repayment can be in cash or stock, at Emisphere’s option. The stock price will be set at the time of conversion.
About Recombinant Human Parathyroid Hormone (PTH1-34)
PTH1-34 is a fragment of the naturally occurring human parathyroid hormone that is an important regulator of calcium and phosphorus metabolism. When given by daily injection, PTH1-34 has been shown to increase bone mineral density and significantly reduce both vertebral and non-vertebral fractures in postmenopausal women. For example, subcutaneous PTH1-34 given with calcium and vitamin D reduced the risk of vertebral fractures by 65 percent compared to calcium and vitamin D alone. With respect to bone mineral density (BMD), daily subcutaneous PTH1-34 produced a 12 percent increase in lumbar spine BMD after 18 months of treatment. Studies will investigate whether the nasal formulation will produce the same results. Daily injections of PTH1-34 are approved for the treatment of postmenopausal osteoporosis. Osteoporosis is a major public health issue. According to the National Osteoporosis Foundation, 10 million Americans suffer from osteoporosis, with an associated annual national health expenditure of more than $17 billion.
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 injectable drugs, 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 .
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 29, 2004.
Emisphere Technologies, Inc.
CONTACT: Elliot M. Maza, CPA, J.D., Chief Financial Officer of EmisphereTechnologies, Inc., +1-914-785-4703; or Media - Dan Budwick of BMCCommunications, +1-212-477-9007, ext. 14, for Emisphere Technologies, Inc.
Web site: http://www.emisphere.com/
