EXHIBIT 99.1
For further information contact:
AT EMISPHERE TECHNOLOGIES, INC. Investors
Elliot Maza Betsy Brod/Jonathan Schaffer
Chief Financial Officer Brod & Schaffer, LLC
(914) 785-4742 212.750.5800
Media
Dan Budwick
BMC Communications
212.477.9007 ext.14
EMISPHERE TECHNOLOGIES ANNOUNCES LICENSING AGREEMENT WITH
NOVARTIS PHARMA AG FOR ORAL FORMULATION OF HUMAN GROWTH
HORMONE
Tarrytown, NY - September 23, 2004 --- Emisphere Technologies, Inc. (NASDAQ:
EMIS) announced today that it has entered into a licensing agreement with
Novartis Pharma AG (NYSE:NVS) to develop an oral formulation of recombinant
human growth hormone (rhGH).
The companies formed the agreement following successful completion of
pre-clinical feasibility studies for rhGH with Emisphere's eligen(R) technology.
Emisphere has identified delivery agents that can deliver therapeutically
sufficient levels of rhGH to the blood stream when administered orally. The lead
carrier for rhGH has completed extensive formulation and preclinical safety
studies.
This collaboration marks the second between the two companies. In 2000 Emisphere
and Novartis entered into a license agreement for the development of oral salmon
calcitonin for the treatment of osteoporosis.
Under the terms of the new agreement, Novartis will pay Emisphere up to $34
million during the course of product development, and a royalty increasing to
double-digit rates based upon sales. Including the initial payment, Emisphere
could receive up to $6 million over the course of the next year.
Emisphere will work with Novartis to initiate clinical trials of a convenient,
oral human growth hormone product using its eligen(R) technology. Novartis will
fully fund the program including all clinical studies.
Michael M. Goldberg, M.D., Chairman and Chief Executive Officer, Emisphere
Technologies, Inc., commented, "We are extremely pleased to expand on our
successful relationship with Novartis. This new agreement again demonstrates the
technical expertise contained within Emisphere and the value of our eligen(R)
technology. "
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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 HUMAN GROWTH HORMONE
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
sale of injectable growth hormone products is currently estimated at over $2
billion.
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.
CONFERENCE CALL INFORMATION
Emisphere will hold a teleconference to discuss this announcement on September
23, 2004 beginning at 2:00 p.m. Eastern Time (11:00 a.m. Pacific Time). A replay
of the call will be accessible approximately 2 hours following the end of the
call and will be archived through September 30, 2004.
The dial-in information is as follows:
in the U.S. and Canada please dial: 800-231-5571
outside of the U.S. please dial: 973-582-2703
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A replay of this call will be available 2 hours after the call is
completed, and will be accessible for one week, thereafter.
To listen to this replay
in the U.S. and Canada please dial: 877-519-4471
outside of the U.S. please dial: 973-341-3080
Reference call identification number: 5214675
Emisphere will be simultaneously webcasting this teleconference. To access the
live broadcast in listen-only mode, please go to the investor relations portion
of the Company's website at http://www.emisphere.com/ir.asp. Please visit these
sites at least five minutes prior to start time for instructions. A replay of
the call will also be available on the Company's website through September 30,
2004.
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.
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