PHILADELPHIA, PA – March 21, 2012 —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 Pharma commented, “This new commercial supply agreement with Tarsa Therapeutics is especially gratifying because it reflects the excellence of the work we have conducted for the company during the clinical development of OSTORA. We appreciate their continuing confidence and look forward to the opportunity to support the successful commercialization of the first-ever oral calcitonin product expected to reach the market.”
Tarsa’s 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. The study is evaluating the ability of oral calcitonin to prevent osteoporosis and maintain bone mass in this population.
Tarsa is developing its OSTORA oral calcitonin under a licensing agreement with Unigene Laboratories that provides Tarsa with exclusive development and worldwide commercialization rights to Unigene’s oral calcitonin product, with the exception of China.
About QS Pharma
QS Pharma, located near Philadelphia in Boothwyn, PA, provides a broad range of contract development/research and clinical/commercial manufacturing services for pharmaceutical and biopharmaceutical companies worldwide. Founded on the tenet of Quality with Speed™, QS Pharma has extensive pharmaceutical product development expertise and knowledge. Its facility consists of over 43,000 sq ft of analytical laboratories and drug product manufacturing space with state-of-the-art cGMP manufacturing suites that can accommodate batch sizes ranging from <1kg to over 300kg. For more information, see www.qspharma.com.
About Tarsa Therapeutics
Tarsa Therapeutics is developing OSTORA™, a novel oral formulation of calcitonin for the treatment and prevention of postmenopausal osteoporosis. OSTORA is expected to be the first approved oral calcitonin, a natural hormone with a long history of safety and efficacy as an osteoporosis therapy. Availability of an oral calcitonin for osteoporosis is expected to generate wider use as doctors and patients are seeking new options that are safe and effective. Tarsa has reported positive efficacy and safety results from a Phase III trial of OSTORA in the treatment of postmenopausal osteoporosis, and a Phase II osteoporosis prevention trial is underway. The company is preparing to submit marketing applications in the US and Europe for OSTORA as a treatment for osteoporosis. Tarsa is based in Philadelphia, PA. For more information, visit www.tarsatherapeutics.com.