TARRYTOWN, N.Y., Nov. 3 /PRNewswire-FirstCall/ -- Emisphere Technologies,
Inc. (Nasdaq: EMIS) today announced that it has received permission from
regulatory authorities in India to commence a Phase II trial for its oral
insulin product.
Emisphere intends to initiate patient enrollment later this month for a
90-day, multi-center, double-blind, randomized clinical trial. The four arm
study will evaluate the safety and efficacy of low and high doses of oral
insulin tablets versus placebo in 120 subjects with Type 2 Diabetes Mellitus
who have inadequate glycemic control with their existing oral antidiabetic
monotherapy. The primary efficacy endpoint of the study is related to the
change in hemoglobin A1c, the standard for evaluating glucose control in
Type II diabetics. Emisphere also will focus on the safety of oral insulin,
specifically incidents of hypoglycemia as well as the occurrence of insulin
antibodies. Emisphere had submitted this Protocol over thirty days ago to the
US FDA and is now proceeding with the Trial.
"We are pleased to receive the go-ahead from Indian regulatory authorities
to conduct our Phase II oral insulin clinical trial, and will begin the study
in the coming weeks," commented Michael M. Goldberg, M.D., Chairman and Chief
Executive Officer of Emisphere Technologies. "This marks an important
milestone for one of our key, internally developed programs. India has a large
diabetic patient population and provides Emisphere, with the help of its
locally based CRO, the opportunity to rapidly enroll patients in a cost
effective manner. We anticipate that this study will be critical to
demonstrating our belief that orally administered insulin is a safe and
effective drug for Type II diabetic patients."
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
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 Annual Report on Form 10-K (file no. 1-10615)
filed on March 29, 2004.
SOURCE Emisphere Technologies, Inc.
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Related links:
http://www.emisphere.com
CONTACT:
Investor Relations - Gillian Racine of
Emisphere Technologies, Inc., +1-914-785-4742; or Media - Dan
Budwick of BMC Communications, +1-212-477-9007, ext. 14, for
Emisphere Technologies, Inc.
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