QS Pharma to Produce OSTORA for Tarsa Therapeutics
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.
Source: Tarsa Therapeutics, via PR Newswire