Tarsa Therapeutics Completes $28 Million Series B Financing to Advance OSTORA™ Oral Calcitonin
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.
About Tarsa Therapeutics
Tarsa Therapeutics is developing OSTORA, a novel oral formulation of calcitonin for the treatment and prevention of postmenopausal osteoporosis. OSTORA is expected to be the first approved oral calcitonin, a natural hormone with a long history of safety and efficacy as an osteoporosis therapy. Availability of an oral calcitonin for osteoporosis is expected to generate wider use as doctors and patients are seeking new options that are safe and effective. Tarsa has reported positive efficacy and safety results from a Phase III trial of OSTORA in the treatment of postmenopausal osteoporosis, and a Phase II osteoporosis prevention trial is underway. The company is preparing to submit marketing applications in the US and Europe for OSTORA as a treatment for osteoporosis. Tarsa is based in Philadelphia, PA. For more information, visit www.tarsatherapeutics.com.
About Foresite Capital
Foresite Capital was founded in 2011 to focus on a new investment strategy to buy ownership in late-stage healthcare companies with significant medical advances. Foresite invests between $10 million and $50 million per investment in companies with strong leadership and proven late-stage products and technologies addressing scalable, high growth, high value markets. Foresite uses its deep network and expertise in partnership with its entrepreneurs to help them attain market leadership. For information, visit www.foresitecapital.com.
About Novo A/S
Novo A/S is an active and independent company in its support of biotech ventures. The aspiration is to bring together the best of both worlds: industry insight and network from our pharma/biotech inheritance combined with a venture capital mindset that focuses on results and value creation. Novo has invested in more than 50 portfolio companies. There is considerable diversity in the portfolio across technologies, products and financial stages. The portfolio is international, currently with more than half the invested capital in North American companies and the rest in Europe. Learn more at www.novo.dk.
About MVM Life Science Partners LLP
MVM Life Science Partners LLP invests in select opportunities in healthcare. MVM was founded in 1997, manages three funds totaling more than $500 million, and has a complementary team with broad experience in London and Boston. Learn more at www.mvmlifescience.com.
About Quaker Partners
Quaker Partners seeks to deliver superior financial returns by investing in healthcare companies developing innovative and cost effective medical solutions. Quaker diversifies by pursuing investments across all sectors of the healthcare industry, including: pharmaceuticals, biotechnology, healthcare services, and medical technologies such as devices, tools and human diagnostics. The firm invests in companies at various stages of development, from start-ups to commercial stage companies that are marketing products and services. Founded in 2003, Quaker manages over $700 million in committed capital. Learn more at www.quakerpartners.com.
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SOURCE Tarsa Therapeutics, Inc.