Tarsa Therapeutics has scooped up the capital it needs to seek approvals of its first drug. The developer has raised $28 million in a second-round financing to advance an application for FDA approval of its calcitonin tablet for women with osteoporosis.
New backer Foresite Capital led the Series B round, which included repeat investors Novo A/S, MVM Life Sciences Partners and Quaker Partners. Tarsa's latest round comes after the Philadelphia-based company produced upbeat Phase III data last year with its calcitonin treatment in postmenopausal osteoporosis and, more recently, successful pre-NDA meetings with FDA officials. Tarsa said in a press release this morning that it plans to file an NDA for its drug, called Ostora, later this year, and proceeds of the deal will go toward its filing for European approval.
Tarsa's oral calcitonin drug, licensed from Unigene Laboratories ($UGNE), beat a placebo and a nasal spray formulation of the hormone in boosting bone mineral density in the spine after 48 weeks, the company says. And the safety profile of the company's drug was comparable to the spray form of the hormone and the placebo. The oral tablet could be more convenient than nasal spray or injected forms of the hormone, giving Tarsa's product an edge in the marketplace.
"Tarsa is an excellent fit with Foresite's focus on late-stage healthcare companies developing significant medical advances," Jim Tananbaum, Foresite's founder and CEO, stated. "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."
Tananbaum is joining Foresite's board of directors as part of the deal.
- here's the release