Emisphere
Technologies, Inc. (Nasdaq: EMIS) announced that Novartis Pharma AG
and Nordic Bioscience have completed recruitment for a multi-center Phase
III study exploring the safety and efficacy of an oral formulation of
salmon calcitonin using Emisphere's proprietary Eligen Technology to treat
patients with osteoarthritis of the knee. This study, which will be used to
support the filing with health authorities worldwide, includes more than
1,100 patients between 51 and 80 years old with a medical history and
symptoms of knee osteoarthritis. The study will be conducted mainly in
Europe and is estimated to complete second half 2010.
Osteoarthritis ("OA") is a clinical syndrome in which low-grade
inflammation results in joint pain, caused by a wearing-away of cartilage
that cushions the joints and the destruction or decrease of synovial fluid
that lubricates those joints. As OA progresses, pain can result when the
patient bears weight upon the joints, including walking and standing. OA is
the most common form of arthritis, and affects nearly 21 million people in
the United States, accounting for 25% of visits to primary care physicians,
and half of all non-steroidal anti-inflammatory drug prescriptions. It is
estimated that 80% of the population will have radiographic evidence of OA
by age 65.
"The problems associated with osteoarthritis will escalate as the
population ages," said Michael V. Novinski, President and Chief Executive
Officer of Emisphere. "This Phase III study aims at demonstrating that oral
salmon calcitonin, in combination with our Eligen drug delivery technology,
may contribute to solving this problem, and also shows that Emisphere is a
valuable partner in drug development."
About Emisphere Technologies, Inc.
Emisphere is a biopharmaceutical company that focuses on a unique and
improved delivery of therapeutic molecules using its Eligen Technology.
These molecules and compounds could be currently available or in
development. Such molecules are usually delivered by injection; in many
cases, their benefits are limited due to poor bioavailability, slow on-set
of action or variable absorption. The Eligen Technology can be applied to
the oral route of administration as well other delivery pathways, such as
buccal, rectal, inhalation, intra-vaginal or transdermal. The website is:
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 13, 2008 and our Quarterly Report on Form 10-Q for the
quarter ended June 30, 2008, filed on August 11, 2008.
Emisphere Technologies, Inc
emisphere
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