Tarsa, QS in Supply Pact

Tarsa Therapeutics has entered into a commercial supply agreement with QS Pharma for the bulk manufacture of its OSTORA oral recombinant salmon calcitonin tablet. QS Pharma will manufacture the tablets at its facility in PA and they will be used for product launch and commercial sale. QS Pharma had initially supplied small-scale development batches; scale-up and validation activities are currently underway.
 
Tarsa is preparing to file a NDA with the FDA for OSTORA tablet for the treatment of postmenopausal osteoporosis. Tarsa reported positive efficacy and safety results from its Phase III ORACAL trial showing that OSTORA demonstrated statistically significant superiority to both placebo and nasal calcitonin spray in increasing bone mineral density.
 
“This production agreement with QS Pharma is timely as we prepare to submit an NDA for OSTORA later this year,” said 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 said, “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.”