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CEDAR KNOLLS, N.J., Dec 10, 2009 (BUSINESS WIRE) -- Emisphere Technologies, Inc. (OTC BB:EMIS) today announced that an independent Data Monitoring Committee ("DMC") informed Novartis and its partner Nordic Bioscience about their recommendation to proceed with the Osteoporosis ("OP") Phase 3 Study 2303 and the Osteoarthritis ("OA") Phase 3 Study 2301 exploring the safety and efficacy of an oral formulation of salmon calcitonin to treat patients with osteoporosis and osteoarthritis of the knee.
This recommendation is based on a futility analysis of one-year data for all patients enrolled in the study for 12 months and includes both an assessment of safety and efficacy parameters.
Based on this interim analysis, DMC is of the opinion that there are no major or unexpected safety concerns and recommends to proceed with the studies to evaluate the efficacy and safety profile of oral calcitonin at two years as planned.
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, 2008, filed on March 16, 2009, and as amended on Form 10-K/A as filed on April 30, 2009, and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2009, filed on May 7, 2009.
SOURCE: Emisphere Technologies, Inc.
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Daria Palestina, 973-532-8002
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