TARRYTOWN, N.Y., Nov. 3 /PRNewswire-FirstCall/ -- Emisphere Technologies, Inc. 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.
Emisphere Technologies, Inc.
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.
Web site: http://www.emisphere.com/
