Tarsa obtains $10 million senior credit facility to support NDA submission for Ostora tablet

Aug 13 2014

Tarsa Therapeutics, Inc. today announced that it has secured a $10 million senior credit facility from Oxford Finance LLC and Square 1 Bank. The company intends to use the proceeds to support its plans to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for its Ostora tablet for the treatment of postmenopausal osteoporosis, currently targeted for early 2015. Separately, Tarsa announced that Daniel Soland has been appointed to the company's Board of Directors.

"As we prepare to file the NDA for our oral recombinant calcitonin tablet, we are pleased to have the support of these two respected financial institutions who have a great deal of experience in the life sciences and venture communities," noted David Brand, President and CEO of Tarsa. "We believe Ostora may be an attractive therapeutic option for many of the millions of women with osteoporosis who cannot or will not take other therapies. Our oral calcitonin is well-tolerated and has been shown to have a positive effect on bone mineral density at the lumbar spine. Our research suggests that many women would welcome the option of calcitonin in a once-daily oral formulation."

In a Phase III global, randomized, double-blind clinical study in postmenopausal women with osteoporosis known as the ORACAL trial, Tarsa's once-daily oral calcitonin demonstrated superiority to both placebo and commercially-available nasal calcitonin spray in increasing bone mineral density at the lumbar spine after 48 weeks. In the trial, the safety profile of Tarsa's oral calcitonin did not substantially differ from nasal calcitonin or placebo. The trial results were published in the Journal of Bone and Mineral Research.

Daniel Soland was Vice President and Chief Operating Officer of Viropharma until its acquisition by Shire early in 2014. He helped build the organizational and commercial infrastructure that resulted in an 11-fold increase in Viropharma's share price during his tenure. Previously, as President of Chiron Vaccines, Mr. Soland helped engineer a turnaround that contributed to Chiron's acquisition by Novartis. Earlier, he was President and CEO of Epigenesis Pharmaceuticals. At GlaxoSmithKline Biologicals, Mr. Soland served as Vice President and Director, Worldwide Marketing Operations. Earlier in his career, Mr. Soland held positions of increasing responsibility in sales and product management at Pasteur-Merieux's Connaught Laboratories. He holds a BS in Pharmacy degree from the University of Iowa.

Tarsa's Chairman, Eric Bednarski, commented, "Dan Soland brings to Tarsa a diverse set of operating and sales and marketing experiences and he has led fast growing, profitable commercial organizations. We are delighted to have him join our board as we finalize the NDA for Ostora and prepare to commercialize this important new osteoporosis therapy."