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news.Tarsa Therapeutics has entered into a commercial supply agreement with QS Pharma for the bulk manufacture of its OSTORA oral recombinant salmon calcitonin tablet.
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The OSTORA tablets, which will be manufactured in QS Pharma’s Pennsylvania facility, will be used for product launch and commercial sale.
This new agreement builds on the continuing collaboration between Tarsa and QS Pharma, the companies said.
Tarsa reported positive efficacy and safety results from its Phase III ORACAL trial showing that OSTORA achieved all the efficacy endpoints.
Oral calcitonin is also being assessed in a one-year double-blind Phase II study comparing the OSTORA tablet to placebo in postmenopausal women who have low bone mass (osteopenia) and are at increased risk of fracture.
Tarsa chief executive officer David Brand said the production agreement with QS Pharma is timely as the company prepares to submit an NDA for OSTORA later in 2012.