пятница, 13 мая 2011 г.

Initiation Of Phase III Program Using Emisphere's Eligen(R) Technology For Oral Salmon Calcitonin

Emisphere
Technologies, Inc. ("Emisphere") (Nasdaq: EMIS) announced today that
Novartis Pharma AG and its development partner Nordic Bioscience have
notified Emisphere of the initiation of a Phase III clinical trial for the
treatment of osteoporosis with an oral form of salmon calcitonin (referred
to as SMC021), a new drug candidate, using Emisphere's eligen(R) delivery
technology. As a result of the initiation of the trial, Emisphere will
receive a milestone payment from Novartis. The use of Emisphere's novel
eligen(R) technology reflects the potential that for the first time salmon
calcitonin may also be available as a convenient oral medication, rather
than the currently available injectable or intranasal options. (1)


Osteoporosis is a disease that reduces the density and quality of bone
and worldwide affects an estimated 75 million people in Europe, the United
States and Japan. (2) The Phase III trial, which will include more than
4,500 osteoporosis patients in Europe, United States, China and Latin
America, is a three year, randomized, multi-center, placebo-controlled
study to evaluate the safety and efficacy of oral calcitonin.


"Oral calcitonin has potential to be a novel oral treatment option in
the fight against osteoporosis," said Lewis H. Bender, President and Chief
Executive Officer of Emisphere. "We are very excited about the opportunity
to be in Phase III with Novartis and their development partner Nordic
Bioscience. Emisphere has a long working relationship with Novartis on oral
calcitonin and we believe that this study is an important confirmation of
the Emisphere eligen(R) technology."


To reach this point, initiation of this Phase III study, Novartis has
conducted extensive safety testing on both the oral calcitonin product and
the Emisphere technology. There has been a Phase II study, several Phase I
clinical trials and extensive preclinical safety studies conducted. Carrier
and drug product materials (including the Phase III clinical trial
materials) have been produced at large scale and also tested in clinical
trials.


Novartis has received CHMP advice on the Phase III trial design and
clearance from FDA to proceed with Phase III study under a special protocol
assessment. The clinical trial is being conducted by Nordic Bioscience
following a development agreement with Novartis.


In 2000, Emisphere and Novartis Pharma AG entered into a license
agreement for the development of oral salmon calcitonin for the treatment
of osteoporosis. The two companies entered into additional license
agreements for the development of oral human growth hormone and an oral
form of parathyroid hormone (PTH) fragment 1-34 in 2004 and 2006,
respectively.


About Salmon Calcitonin


Calcitonin is a polypeptide hormone secreted by the parafollicular
cells of the thyroid gland. Calcitonin enables the bone to retain more of
its mass and functionality by inhibiting the bone-tissue resorbing activity
of specialized bone cells called osteoclasts. (3) Calcitonin is involved in
the regulation of calcium and the decrease of bone loss and fractures.
Calcitonin derived from salmon is estimated to be about 30 times more
potent than the human version. Synthetic salmon calcitonin, which is
identical to the natural salmon calcitonin, is currently available only as
nasal spray or as an injectable therapy.















About Osteoporosis


Osteoporosis is a progressive disease that causes bones to become thin
and brittle, making them more likely to break. The number of patients in
the United States, Europe and Japan with osteoporosis or low bone mineral
density is estimated at 75 million. (2) Osteoporosis may result in broken
bones and fractures in the spine and hip. Hip fractures often require
hospitalization, and fractures of the bones in the spine (vertebrae) can
cause loss of height and severe back pain. Both may lead to permanent
disability.


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 emisphere.


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 and our Quarterly Reports on Form 10-Q for the
quarters ended March 31, 2006, June 30, 2006 and September 30, 2006.


References


1. Emisphere Technologies, Inc. Available at:
emisphere/ot_tet.asp. Accessed January 29, 2007.


2. International Osteoporosis Foundation. "Facts and statistics about
osteoporosis and its impact." iofbonehealth/facts-and-statistics.html. Accessed December 18, 2006.


3. Azria M. The Calcitonins: Physiology and Pharmacology. Basel, Karger.
1989.


Emisphere Technologies, Inc.

emisphere/

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