CEDAR KNOLLS, N.J., July 23, 2010 (GLOBE NEWSWIRE) -- Emisphere
Technologies, Inc. (OTCBB:EMIS) today announced that Novartis Pharma AG
and its license partner Nordic Bioscience a/s (the "Sponsor") have
reported the following in connection with their Phase III Study 2302 in
osteoarthritis assessing the safety and efficacy of oral calcitonin in
the treatment of osteoarthritis of the knee. This study incorporates
Emisphere's unique and proprietary Eligen(R) Drug Delivery Technology
for the improved oral absorption of salmon calcitonin.
An independent Data Monitoring Committee ("DMC") conducted a futility
analysis of one-year data for all patients enrolled in this two-year
study, including assessments of safety and efficacy parameters. The DMC
concluded that although there is no reason to stop Study 2302 because
of safety concerns, there is no reason to continue the study for
efficacy. The DMC also concluded that the final decision whether to
continue Study 2302 rests with the Sponsor.
A parallel two-year Phase III Study 2301 in osteoarthritis assessing
the safety and efficacy of oral calcitonin in the treatment of
osteoarthritis of the knee is still in progress. In December 2009, the
DMC conducted a futility analysis of one-year data for all patients
enrolled in this two-year study, including assessments of safety and
efficacy parameters, and recommended to continue with such Study.
The Sponsor currently intends to continue the clinical program of oral
calcitonin in osteoarthritis, including both Phase III Study 2301 and
Phase III Study 2302. Novartis and Nordic Bioscience will continue to
work together to assess next steps once the final data of Study 2301 is
available. This data is expected to be available in 4Q-2010.
Additionally, the Sponsor currently intends to continue the clinical
program of oral calcitonin in osteoporosis. Previously, in its
quarterly earnings report for the period ended June 30, 2010, Novartis
stated that oral calcitonin for the treatment of osteoporosis is
planned to file with the regulatory authorities during 2011.
About Emisphere Technologies, Inc.
Emisphere is a biopharmaceutical company that focuses on the unique and
improved delivery of therapeutic molecules or nutritional supplements
using its proprietary Eligen(R) Technology. The Eligen(R) Technology
can be applied to the oral route of administration as well as other
delivery pathways such as buccal, rectal, inhalation, intra-vaginal or
transdermal. The company's website is 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 for the fiscal year ended
December 31, 2009 (file No. 000-17758), filed on March 25, 2010.
CONTACT: Emisphere Technologies, Inc.
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