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Tarsa Therapeutics Signs Commercial Supply Agreement for its Ostora™ Oral Calcitonin Product With QS Pharma
Date:3/21/2012

PHILADELPHIA, March 21, 2012 /PRNewswire/ -- Tarsa Therapeutics today announced it has entered into a commercial supply agreement with QS Pharma for the bulk manufacture of its OSTORA™ oral recombinant salmon calcitonin tablet.  The OSTORA tablets, which will be manufactured in QS Pharma's state-of-the-art facility in Pennsylvania, will be used for product launch and commercial sale.

This new agreement builds on the continuing collaboration between Tarsa and QS Pharma that began with an initial agreement for small-scale development batches and progressed to the scale-up and validation activities currently underway.

Following positive Phase III results and a successful pre-NDA meeting with the FDA, Tarsa is preparing to file a New Drug Application (NDA) with the US Food and Drug Administration (FDA) later this year for its OSTORA tablet for the treatment of postmenopausal osteoporosis.  Tarsa reported positive efficacy and safety results from its Phase III ORACAL trial showing that OSTORA achieved all the efficacy endpoints and demonstrated statistically significant superiority to both placebo and nasal calcitonin spray in increasing bone mineral density at the lumbar spine after 48 weeks.  The safety profile of OSTORA did not substantially differ from nasal calcitonin or placebo.  As the first once-daily oral calcitonin tablet expected to reach the market, OSTORA has the potential to offer patients and physicians the proven safety and efficacy of calcitonin with the advantage of significantly easier administration. 

"This production agreement with QS Pharma is timely as we prepare to submit an NDA for OSTORA later this year," noted David Brand, Chief Executive Officer of Tarsa.  "We have been impressed in our dealings to date with the QS Pharma team and are pleased to have secured a highly qualified manufacturer located just a few miles from our headquarters." 

Nutan Gangrade, President of QS
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SOURCE Tarsa Therapeutics
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