TARRYTOWN, N.Y., March 8 /PRNewswire-FirstCall/ -- Emisphere Technologies,
Inc. (Nasdaq: EMIS) ("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. (Nasdaq: EMIS) 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.
SOURCE Emisphere Technologies, Inc.
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Related links:
http://www.emisphere.com
CONTACT:
Elliot M. Maza, CPA, J.D., Chief Financial
Officer of Emisphere Technologies, Inc., +1-914-785-4703; or
Media - Dan Budwick of BMC Communications, +1-212-477-9007, ext.
14, for Emisphere Technologies, Inc.
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