Novartis Pharma AG elects to develop oral growth hormone using Emisphere's
technology
Emisphere to receive $5 million milestone payment
TARRYTOWN, N.Y., May 1 /PRNewswire-FirstCall/ -- Emisphere
Technologies, Inc. ("Emisphere", Nasdaq: EMIS) announced today that
Novartis Pharma AG has notified Emisphere that Novartis Pharma AG will
initiate the development of an oral human growth hormone (rhGH) product
using Emisphere's eligen(R) delivery technology. Emisphere is entitled to a
$5 million development commencement milestone payment as a result of the
Novartis Pharma AG decision to proceed with product development.
"We are very pleased that Novartis has elected to commence this oral
product development using our technology," commented Michael M. Goldberg,
M.D., Chairman and Chief Executive Officer of Emisphere. "We are eagerly
awaiting the results of a study which we hope will show that such a large
and complex protein can be delivered orally in an active form by
Emisphere's eligen(R) delivery technology. The study is currently on-going,
however positive results would exemplify the utility of Emisphere's
eligen(R) technology for the oral delivery of large proteins similar in
size and complexity to rhGH."
Novartis Pharma AG notified Emisphere that it had initiated a multidose
study in growth hormone-deficient adults with the oral formulation of rhGH
in Q1 this year. Once finished, the results of the trial will be
communicated in an appropriate and timely manner.
The payment of this development commencement milestone is 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(R) technology.
In 2000, Emisphere and Novartis 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(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)(R) technology to
those drugs or licensing its eligen(R)(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 16, 2006.
SOURCE Emisphere Technologies, Inc.
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Related links:
http://www.emisphere.com
CONTACT:
Elliot Maza, Chief Financial Officer,
Emisphere Technologies, Inc., +1-914-785-4742; or Dan Budwick of
BMC Communications for Emisphere Technologies, Inc.,
+1-212-477-9007 ext.14
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