Emisphere Announces Initiation Of Phase III Clinical Program Of Oral Calcitonin For The Treatment Of Osteoarthritis

Emisphere
Technologies, Inc. ("Emisphere") (Nasdaq: EMIS) has been notified that
Novartis Pharma AG and its development partner Nordic Bioscience have
initiated the Phase III clinical program of oral calcitonin (referred to as
SMC021) for the treatment of osteoarthritis, a chronic, irreversible and
degenerative condition. The oral calcitonin product is a new drug candidate
with potential to be the first disease-modifying drug for
osteoarthritis(i),(ii).


The salmon calcitonin is formulated in tablet form using Emisphere's
novel eligen(R) delivery technology. Emisphere's technology creates the
potential for salmon calcitonin to be available as a convenient oral
medication for the first time.



"We are pleased to announce the initiation of Phase III trials for oral
calcitonin, which may represent the first disease-modifying drug for the
treatment of osteoarthritis," said Michael V. Novinski, President & CEO of
Emisphere. "Currently, there are no available treatment options for
osteoarthritis that actually help prevent disease progression or joint
damage, and we are excited to be at the leading edge of research in this
area. An unmet need facing osteoarthritis patients and physicians today is
the lack of any proven disease-modifying drug for osteoarthritis. Oral
Calcitonin would help prevent structural damage in at-risk joints, or the
progression of structural damage in joints already affected. Current
treatment options for osteoarthritis provide only symptomatic relief"(iii).



In osteoarthritis, oral calcitonin may stimulate a protective effect
that helps maintain the quality of cartilage and reduce the progression of
joint space narrowing(iv). Oral calcitonin also has been shown to protect
against cartilage breakdown in animal models.



The Phase III clinical program is being conducted by Nordic Bioscience
both in the European Union and in the US, and is planned to include more
than 2000 patients.



In 2000, Emisphere and Novartis Pharma AG entered into a license
agreement for the development of oral salmon calcitonin for the treatment
of osteoarthritis and osteoporosis. The Phase III clinical trial of oral
calcitonin for the treatment in osteoporosis started also early this year.
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. 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 versioni.(iv) Synthetic salmon calcitonin, which is
identical to the natural salmon calcitonin, is currently available only as
nasal spray or as an injectable therapy.
















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 Oral Calcitonin



Oral calcitonin is a novel drug under clinical development for the
potential treatment of both osteoarthritis and osteoporosis. It has a dual
method of action that could provide the unique benefit of protecting bones
and preserving cartilage in patients with osteoarthritis and osteoporosis,
all in one medication(v).



Oral calcitonin is formulated with a novel new technology that for the
first time facilitates the convenient oral dosing of calcitonin. The oral
calcitonin compound consists of the peptide hormone (calcitonin) and
5-CNAC, a delivery agent for increasing gastrointestinal absorption, and
uses Emisphere Technologies' eligen(R) technology, which is an advanced
drug delivery system that facilitates the oral delivery of active
calcitonin without altering the drug's biological characteristics or
benefits(vi).



Calcitonin is a natural hormone secreted by the thyroid gland that is
important for bone formation and maintenance. It helps regulate normal
blood calcium levels and inhibitors cells that are responsible for bone
degradation(iv). Synthetic calcitonin has been used as an injectable
medication for more than 30 years and as an intranasal formulation since
1987.



About Osteoarthritis



Osteoarthritis is the most common form of arthritis, affecting 20
million people in the U.S. alone. Osteoarthritis, also called degenerative
joint disease, is the most common type of arthritis. It is associated with
a breakdown of cartilage in joints and can occur in almost any joint in the
body. It most commonly occurs in the weight bearing joints of the hips,
knees and spine. It can also affect the fingers, neck and large toe. It
rarely affects other joints unless prior injury or excessive stress is
involved. Cartilage is a firm, rubbery material that covers the ends of
bones in normal joints. Its main function is to reduce friction in the
joints and serve as a "shock absorber." The shock-absorbing quality of
normal cartilage comes from its ability to change shape when compressed
(flattened or pressed together). Osteoarthritis causes the cartilage in a
joint to become stiff and lose its elasticity, making it more susceptible
to damage. Over time, the cartilage may wear away in some areas, greatly
decreasing its ability to act as a shock absorber. As the cartilage
deteriorates, tendons and ligaments stretch, causing pain. If the condition
worsens, the bones could rub against each other.



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 the Emisphere website,
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 (Commission File no. 1-10615) Annual Report
on Form 10-K (File 000-17758) filed on March 6, 2007 and our Quarterly
Report on Form 10-Q for the quarter ended March 31, 2007.



References


i. Kardsal MA, Sondergaard BC, Madsen SH, Wulf, H. Sumer EU, Olsen AK,
Qvist P, Christiansen C, Nordic Bioscience, Herlev, Denmark, CCBR
Ballerup, Denmark. "Induction of cAMP levels switches chondrocytes
phenotype from catabolic to anabolic - Implications for novel
treatments of osteoarthritis." Abstract Control/Tracking Number: #
06- A-1085-ASBMR, presented at ASBMR 28th Annual Meeting,
Philadelphia, April 19, 2006.


ii. Karsdal MA, Sondergaard BC, Sims NA, Gooi JH, Qvist P, Christiansen
C, Nordic Bioscience, Herlev, Denmark, SVIMR, Melbourne, Australia,
CCBR Ballerup, Denmark. "Calcitonin directly modulates chondrocyte
activity in vitro and abrogates collagen type II degradation in
vivo." Abstract Control/Tracking Number: # 06-A-1049-ASBMR,
presented at ASBMR 28th Annual Meeting, Philadelphia, April 19, 2006.


iii. Datamonitor, March 2006.


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


v. 2 Oct Briefing new BF Head/ Milka Bedikian/ October 24, 2006.


vi. Emisphere Technologies, Inc. Available at
emisphere/ot_tet.asp. 2007.


Emisphere Technologies, Inc.

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