- Completed Phase I study in 8 patients shows drug absorption
- Elevated levels of IGF-I are seen in patients
TARRYTOWN, N.Y., Sept. 5 /PRNewswire-FirstCall/ -- Emisphere
Technologies, Inc. ("Emisphere") (Nasdaq: EMIS) announced today that
Novartis Pharma AG has notified Emisphere of new Phase I data indicating
that recombinant human growth hormone (rhGH) can be absorbed when given to
growth hormone-deficient (GHD) patients in a prototype oral formulation
using Emisphere's eligen(R) delivery technology.
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(R) 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(R) 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(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 16, 2006.
SOURCE Emisphere Technologies, Inc.
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Related links:
http://www.emisphere.com
CONTACT:
Stewart Siskind of Emisphere Technologies,
Inc., +1-914-785-4742; or Media: Dan Budwick of BMC
Communications, +1-212-477-9007 ext. 14
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