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GEN News Highlights : Mar 16, 2012

Tarsa Raises $28M to Take Oral Calcitonin Through Regulatory Approval in the U.S.

Once-daily Ostora is being evaluated for treatment and prevention of postmenopausal osteoporosis.

Tarsa Therapeutics raised $28 million in a Series B round of financing to fund progression of its once-daily oral calcitonin product Ostora™ through the regulatory approval process in the U.S. and Europe. The firm is currently preparing to file an NDA with FDA later this year requesting approval of Ostora as a treatment for postmenopausal osteoporosis.

The Series B funds will support the NDA filing process, preparation of a European Marketing Authorization Application, and essential precommercialization activities. The financing round was led by new investor Foresite Capital. Tarsa’s existing venture capital investors all participated.

Tarsa is developing Ostora under an exclusive worldwide (excluding China) development and commercialization agreement with Unigene. Data from the pivotal Phase III Oracal study showed that the drug met all its efficacy endpoints and was significantly more effective than nasal calcitonin spray with respect to increasing bone mineral density at the lumbar spine after 48 weeks.

If regulatory clearance is granted, the firm says Ostora is likely to be the first approved oral calcitonin. The drug is separately undergoing Phase II development for the prevention of osteoporosis and maintenance of bone mass in postmenopausal women with ostopenia who are at increased risk of fracture.