Emisphere Phase III Program/Oral Calcitonin/Osteoarthritis

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Emisphere Announces Initiation Of Phase III Clinical Program Of Oral

Calcitonin For The Treatment Of Osteoarthritis

Article Date: 25 May 2007 - 0:00 PDT

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® 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 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® Technology

Emisphere's broad-based oral drug delivery technology platform, known

as the eligen® technology, is based on the use of proprietary,

synthetic chemical compounds, known as EMISPHERE® 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® 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

® 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® technology to those drugs or licensing its

eligen® technology to partners who typically apply it directly to

their marketed drugs. Emisphere's eligen® 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, 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 (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

http://www.emisphere.com/ot_tet.asp. 2007.

Emisphere Technologies, Inc.

http://www.emisphere.com