No Further Toxicology Studies are Planned for the NDA Submission of Oral
Calcitonin
TARRYTOWN, N.Y., May 25 /PRNewswire-FirstCall/ -- Emisphere
Technologies, Inc. ("Emisphere", Nasdaq: EMIS) announced today that
Novartis Pharma AG has notified Emisphere that Novartis Pharma AG has
completed the planned preclinical safety studies for the oral calcitonin
product using Emisphere's eligen(R) delivery technology.
In a recently finalized report, Novartis has concluded that oral
administration of the eligen(R) delivery agent administered by gavage to
rats for 104 weeks is not considered carcinogenic at doses up to 750 mg per
kilogram per day. The carcinogenicity report would be submitted to the U.S.
Food and Drug Administration (FDA) in any New Drug Application (NDA)
submission on oral formulations of those molecules for which Novartis has
obtained rights to use the Emisphere technology including calcitonin.
"We are very pleased that Novartis has generated significant safety
data on our technology for its various programs," commented Michael M.
Goldberg, M.D., Chairman and Chief Executive Officer of Emisphere. "It is a
major milestone for our technology that Novartis has now conducted all the
necessary preclinical safety/toxicology studies over the past seven years
required for the NDA submission on oral calcitonin, a chronically
administered product." In 2000, Emisphere and Novartis entered into a
license agreement for the development of oral 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 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 Calcitonin
Calcitonin is a hormone known to participate in calcium and phosphorus
metabolism. In mammals, the major source of calcitonin is from the
parafollicular or C cells in the thyroid gland, but it is also synthesized
in a wide variety of other tissues, including the lung and intestinal
tract. In birds, fish and amphibians, calcitonin is secreted from the
ultimobrachial glands. Calcitonin is a 32 amino acid peptide cleaved from a
larger prohormone. Calcitonin is marketed as a nasal spray and injectable
product. In 2005, sales were approximately $400 million.
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 drugs that are not currently available
or have poor bioavailability in oral form, 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 heparin, insulin, salmon calcitonin, 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 our web site, 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:
Investor Relations: Emisphere Technologies,
Inc., +1-914-785-4742, Info@Emisphere.com; Media: Dan Budwick of
BMC Communications for Emisphere Technologies, Inc.,
+1-212-477-9007 ext. 14
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