CEDAR KNOLLS, N.J., Oct. 13, 2011 (GLOBE NEWSWIRE) -- On July 23, 2010 Emisphere Technologies, Inc. (OTCBB:EMIS) reported that Novartis Pharma AG ("Novartis") and its license partner Nordic Bioscience A/S ("Nordic Bioscience") provided certain information in connection with their Phase III Study 2302 assessing the safety and efficacy of oral calcitonin ("oCT") in the treatment of osteoarthritis of the knee. Study 2302, along with its companion Study 2301, incorporates Emisphere's unique and proprietary Eligen® Drug Delivery Technology for the improved oral absorption of salmon calcitonin. Specifically, in July 2010, Novartis informed Emisphere that an independent Data Monitoring Committee ("DMC") conducted a futility analysis of one-year data for all patients enrolled in Study 2302, including assessments of safety and efficacy parameters. Although the DMC concluded that there was no reason to stop Study 2302 because of safety concerns, there was no reason to continue the study for efficacy. Novartis has informed Emisphere that because of a previously more encouraging futility analysis of Study 2301 (reported by us on Dec 9th, 2009), Novartis and Nordic Bioscience had decided to continue the study to be able to pool results and compare safety information.
Following completion of Study 2302, Novartis has recently informed Emisphere that it has reviewed the first interpretable results and has advised Emisphere of its top line conclusions as follows: Preliminary analysis of two year study data showed both co-primary endpoints and secondary endpoints of the study were not met. Additionally, preliminary analysis of Study 2302 data showed a positive safety profile.
Nordic Bioscience recently presented the results from the two year Phase III Study 2301, the companion study to Study 2302, at the Osteoarthritis Research Society International ("OARSI") World Congress on Osteoarthritis held September 15 – 18, 2011, in San Diego. The results were also published in OARSI Abstract #64, Volume 19, Supplement 1 (ISSN 1063-4584). Specifically, the OARSI abstract contains the conclusion "twice daily oCT over 2 years resulted in a significant symptom-modifying efficacy in patients with painful knee OA as assessed by WOMAC pain, physical function, and stiffness scores. Although improvement on the primary endpoint of JSW (joint-space width) was not reached, there was an increase in cartilage volume vs. placebo indicating some structure-modifying efficacy."
Novartis has not provided Emisphere with any further data from either Study 2302 or Study 2301 at this time. Nordic Bioscience and Novartis have indicated that they are going to continue to work together to further analyze and evaluate the results. Additionally, a Phase III study of oral calcitonin in osteoporosis has been completed and first interpretable results are expected in the fourth quarter of 2011.
About Emisphere Technologies, Inc.
Emisphere is a biopharmaceutical company that focuses on a unique and improved delivery of pharmaceutical compounds, medical foods and dietary supplements 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 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, the sufficiency of Emisphere's cash and other capital resources and its ability to obtain additional financing to meet its capital needs) 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, 2010 (file no. 000-17758) filed on March 31, 2011, Emisphere's Quarterly Report on Form 10-Q for the quarter ended March 31, 2011, filed on May 10, 2011 and Emisphere's Quarterly Report on Form 10-Q for the quarter ended June 30, 2011, filed on August 9, 2011.