>>TARRYTOWN, N.Y., Feb. 26 /PRNewswire-FirstCall/ -- Emisphere Technologies, Inc. (Nasdaq: EMIS - News) today announced favorable results of a Phase IIa study with Novartis Pharma AG evaluating the performance in post-menopausal women of an oral tablet formulation of the peptide, salmon calcitonin ("calcitonin"), which is currently available only as nasal spray or as an injectable therapy. The study demonstrated activity on bone markers over a three month dosing period when the peptide was delivered in combination with the EMISPHERE® delivery agent.
The purpose of the study was to assess the efficacy and safety of various doses of the oral tablet formulation of calcitonin in post-menopausal women and to confirm the activity of calcitonin when given orally, as reflected by changes in markers of bone formation or resorption. The multi-site study was conducted in Europe and included 277 post-menopausal women who were dosed over a three-month period. Five calcitonin doses were administered with a fixed amount of an EMISPHERE® delivery agent. A placebo arm was also included in the study design.
The data from the study demonstrated a calcitonin dose-response, as measured by changes in bone markers after the first, second and third months, as well as a statistically significant effect on bone markers from baseline levels for two of the five doses administered (p = 0.002 and p = 0.016). Additionally, in comparison to placebo, there was a significant reduction in bone markers observed for one of these doses (p = 0.012). Furthermore, only two serious adverse events were reported, neither of which were related to the EMISPHERE® delivery agent or to calcitonin. The side effects seen with the highest doses of calcitonin were consistent with those normally seen with high plasma levels of calcitonin when administered by injection. These side effects were mainly gastrointestinal in nature.
Michael M. Goldberg, M.D., Chairman and Chief Executive Officer of Emisphere Technologies, Inc., commented, "This study represents a significant milestone for Emisphere because it is the second product candidate using our eligen(TM) technology to have undergone dosing of one month or more. The study also represents the longest time period over which our technology has been administered, further demonstrating the safety profile of our eligen(TM) technology and conclusively establishing that this peptide, when administered orally using our technology, remains active."
Dr. Goldberg further noted, "This is Emisphere's sixth macromolecule and the seventh therapeutic to be orally delivered in humans. We look forward to advancing our technology even further with the help of the excellent team working on this program at Novartis."
About Salmon Calcitonin
Calcitonin is a hormone that inhibits the bone-tissue resorbing activity of specialized bone cells called osteoclasts, enabling the bone to retain more of its mass and functionality. Calcitonin is involved in the regulation of calcium and the decrease of bone loss and fractures. Calcitonin derived from the salmon is estimated to be about 30 times more potent than the human version. Synthetic salmon calcitonin, which is identical to the naturally occurring one, is currently available only as nasal spray or as an injectable therapy. Novartis Pharmaceuticals Corporation markets synthetic salmon calcitonin in the United States as Miacalcin® nasal spray, which is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause with low bone mass and should be reserved for postmenopausal women who refuse or cannot tolerate estrogen, or for whom estrogens are contraindicated. Use of calcitonin is recommended in conjunction with adequate calcium and vitamin D intake.
About Osteoporosis and Osteopenia
Osteoporosis is a crippling disease marked by a wasting away of bone mass. The disease affects as many as two million Americans, 80% of them women, at an expense of $13.8 billion annually, according to the National Osteoporosis Foundation. The disease may be responsible for five million fractures of the hip, wrist and spine in people over 50, and may cause 50,000 deaths, according to the foundation. Osteopenia is the presence of less than normal amount of bone and may result in osteoporosis if not treated. Osteopenia progresses into osteoporosis when bone mass is reduced such that the skeleton integrity is compromised.
About the Novartis - Emisphere Collaboration for the Development of an
Oral Formulation of Salmon Calcitonin
In 1997, Novartis Pharma AG signed a research collaboration and option agreement with Emisphere to investigate the feasibility of an oral formulation of salmon calcitonin. In March 2000, Novartis Pharma AG executed a license agreement with Emisphere for the development of an oral formulation of salmon calcitonin, providing for development and regulatory funding, milestone payments to Emisphere, and potential royalties on product sales.
About The eligen(TM) technology
Emisphere's broad-based oral drug delivery technology platform, known as the eligen(TM) technology, to accomplish oral drug delivery, which is based on the use of proprietary, synthetic chemical compounds, known as EMISPHERE® delivery agents, or "carriers." These molecules facilitate the transport of the therapeutic macromolecules across biological membranes such as the small intestine. Emisphere's eligen(TM) technology makes it possible to orally deliver a therapeutic molecule without altering its chemical form or biological integrity.<<
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