| |
EMISPHERE TECHNOLOGIES ANNOUNCES THE COMPLETION OF ENROLLMENT IN SECOND PHASE III STUDY FOR ORAL OSTEOARTHRITIS TREATMENT UTILIZING PROPRIETARY ELIGEN® TECHNOLOGY
Phase III Study to Explore the Effects of Oral Calcitonin, a combination of Salmon Calcitonin and Eligen Delivery Technology on Knee Osteoarthritis Treatment
CEDAR KNOLLS, NJ, June 1, 2009 – Emisphere Technologies, Inc. (NASDAQ: EMIS) announced today that Novartis Pharma AG and Nordic Bioscience have completed recruitment for the planned second multi-center Phase III study exploring the safety and efficacy of an oral formulation of salmon calcitonin using Emisphere’s proprietary Eligen Technology to treat patients with osteoarthritis of the knee. This study, which is intended to be used to support a regulatory filing in the U.S., includes more than 900 patients between the ages of 51 and 80 with a medical history and symptoms of knee osteoarthritis. The study is being conducted in Europe and the U.S., as well as other countries, and is a two year study.
Osteoarthritis (“OA”) is a clinical syndrome in which low-grade inflammation results in joint pain, caused by a wearing-away of cartilage that cushions the joints and the destruction or decrease of synovial fluid that lubricates those joints. As OA progresses, pain can result when the patient bears weight upon the joints, when walking or standing. OA is the most common form of arthritis, and affects nearly 21 million people in the United States, accounting for approximately 15% of visits to primary care physicians. It is estimated that 80% of the population will have radiographic evidence of OA by age 65.
“We are pleased with the progress that has been made with this extensive Phase III program evaluating oral salmon calcitonin in combination with our Eligen® drug delivery technology in osteoarthritis,” said Michael V. Novinski, President and Chief Executive Officer of Emisphere. “The Eligen® Technology has broad applicability and may help in the development of a safe, effective, and more convenient alternative to existing therapies for osteoarthritis.”
Oral calcitonin is also being investigated using Eligen® Technology in a Phase III study for osteoporosis.
About Emisphere Technologies, Inc.
Emisphere is a biopharmaceutical company that focuses on a unique and improved delivery of therapeutic molecules or nutritional 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 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. 000-17758) filed on March 16, 2009.
# # #
Company contact
Michael Garone, Chief Financial Officer
973-532-8005 or mgarone@emisphere.com
Rx Communications Group:
Eric Goldman (media), 917-322-2563 or egoldman@rxir.com
Paula Schwartz, 917-322-2216 or pschwartz@rxir.com
|
|
