Tarsa advances OSTORA NDA filing through $28M Series B financing

Tarsa Therapeutics, Inc. today announced completion of a $28 million Series B equity financing led by new investor Foresite Capital.  James Tananbaum, MD, Foresite's founder and CEO, is joining Tarsa's Board of Directors.  Tarsa's existing venture capital investors—Novo A/S, MVM Life Science Partners and Quaker Partners—all participated in the new financing round. 

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 OSTORA™, its oral calcitonin tablet for the treatment of postmenopausal osteoporosis.  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.  Proceeds from the Series B financing will support the NDA filing, preparation of a European Marketing Authorization Application (MAA) and essential pre-commercialization activities.

David Brand, President and CEO of Tarsa, said, "We are delighted to welcome experienced biotech entrepreneur and investor Jim Tananbaum as a Tarsa investor and board member, and we appreciate the continuing confidence of our existing investors who have supported Tarsa from the beginning.  This is an exciting time for the company as we prepare to file an NDA for OSTORA, and we are encouraged by the continuing strong interest in OSTORA from potential marketing partners."

"Tarsa is an excellent fit with Foresite's focus on late-stage healthcare companies developing significant medical advances," said Dr. Tananbaum.  "We believe there is substantial unmet need for additional safe and effective options for the treatment and prevention of osteoporosis, and we welcome the opportunity to support Tarsa as it advances OSTORA through regulatory approval and preparations for commercialization."

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 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.

Tarsa's oral calcitonin is also being assessed in a one-year double-blind Phase II study comparing OSTORA 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.