Novartis Pharma AG initiates second Phase I trial for oral PTH1-34: Emisphere Technologies

Apr 16 2010

Emisphere Technologies, Inc. (OTCBB:EMIS) today announced that Novartis Pharma AG has initiated a second Phase I trial for an oral PTH1-34 which uses Emisphere's Eligen^® Technology, and is in development for the treatment of postmenopausal osteoporosis. Emisphere Technologies is a biopharmaceutical company that focuses on a unique and improved delivery of pharmaceutical compounds and nutritional supplements using its Eligen^® Technology.

The study is a partially blinded, placebo controlled, active comparator study to explore the safety, tolerability, pharmacokinetics and pharmacodynamics in postmenopausal women after daily oral doses of PTH1-34.

The study has two parts (A and B) and will enroll a total of approximately up to 120 postmenopausal women. In Part A of the trial, ascending doses of oral PTH1-34 using the Eligen^® Technology will be tested for safety, tolerability and pharmacokinetics and compared to Forsteo^®. In Part B, in addition to safety and tolerability of oral PTH1-34 using the Eligen^® Technology, pharmacodynamic responses will be measured by bone biomarker levels and bone mineral density, and compared to Forsteo^®. First patient enrollment is planned in April.

Commenting on today's news, Michael V. Novinski, President and Chief Executive Officer of Emisphere, stated, "We are pleased to announce the initiation of a second Phase 1 trial for oral PTH1-34 using our Eligen^® Technology, sponsored by Novartis. The successful development of a safe and effective oral formulation of PTH1-34 will be a welcome option for a large number of patients for whom injection is the only currently available therapy."

SOURCE Emisphere Technologies, Inc.