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Tarsa Therapeutics Reports Positive Top-Line Results From Pivotal Phase III ORACAL Trial of its Oral Calcitonin in Treatment of Postmenopausal Osteoporosis
Date:3/24/2011

PHILADELPHIA, March 24, 2011 /PRNewswire/ -- Tarsa Therapeutics today announced that the Phase III ORACAL trial of its oral recombinant salmon calcitonin in the treatment of postmenopausal osteoporosis was successfully concluded and yielded statistically significant, positive top-line results.  The results will be used to support a New Drug Application (NDA) submission to the Food and Drug Administration (FDA) targeted for the fourth quarter of 2011, based on the study design and specific endpoints that were agreed with the FDA in a Special Protocol Assessment (SPA) agreement. By early 2012, Tarsa also plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA).

The ORACAL study is a Phase III multinational, randomized, double-blind, double-dummy, placebo-controlled trial of Tarsa's oral recombinant salmon calcitonin compared to commercially available, synthetic salmon calcitonin administered by nasal spray.  The trial enrolled 565 postmenopausal women with established osteoporosis in six countries.  The ORACAL study's primary endpoint was the percent change in lumbar spine bone mineral density (BMD) after one year of treatment.  Success required that oral salmon calcitonin be superior to placebo and non-inferior to nasal salmon calcitonin spray in increasing BMD at the lumbar spine. Both results were positive and statistically significant.  The trial also assessed the tolerability of oral calcitonin, which was similar to that of calcitonin administered by nasal spray and to placebo. The full data from the study are expected to be presented in a peer-reviewed forum later this year.  

"With these positive Phase III top-line results in hand, we are proceeding with the additional dataset analyses we will need to submit an NDA to the FDA before the end of the year," said David Brand, President and CEO of Tarsa.  "Our tablet has the potential to offer the 30-year record of safety a
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SOURCE Tarsa Therapeutics, Inc.
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