Recently Revised Label for Marketed Calcitonin Products Has Helped Clarify the Regulatory Landscape in the U.S.
Industry Veteran Nicholas LaBella Joins Tarsa as Vice President, Global Regulatory Affairs and Will Oversee the NDA Submission Process
PHILADELPHIA, PA – May 29, 2014 — Tarsa Therapeutics, Inc. today announced that it raised $7 million to prepare for filing a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Ostora, its oral calcitonin tablet for the treatment of postmenopausal osteoporosis. The financing is the second tranche of a Series B round Tarsa announced in May, 2012. All of Tarsa’s existing investors participated in the financing, including Foresite Capital, MVM Life Science Partners, Quaker Partners and Novo A/S.
Separately, Tarsa announced that Nicholas A. LaBella, Jr., MS, RPh, has joined the company as Vice President, Global Regulatory Affairs.
In a Phase III global, randomized, double-blind trial in postmenopausal women with osteoporosis, known as the ORACAL trial, Tarsa’s once-daily oral calcitonin demonstrated superiority to both placebo and nasal calcitonin spray in increasing bone mineral density at the lumbar spine after 48 weeks. In the trial, the safety profile of Ostora did not substantially differ from nasal calcitonin or placebo. The trial results were published in the Journal of Bone and Mineral Research.
“Osteoporosis is a leading cause of disability, yet our aging population has limited choices for the treatment of this potentially devastating condition,” noted David Brand, President and CEO of Tarsa. “We were encouraged by the FDA’s recent decision to allow the continued availability of nasal spray and injectable calcitonin for the treatment of osteoporosis. Calcitonin has been shown to have a modest but consistent positive effect on bone mineral density at the lumbar spine, and we believe Ostora may be an attractive therapeutic option for many of the at-risk women who cannot or will not take other therapies.”
According to a recent journal article, prescriptions for oral bisphosphonates, the most commonly used class of drugs for the treatment of postmenopausal osteoporosis, fell by 53% between 2008 and 2012 (Wysowski et al., J Bone Min Res 2013).
Mr. Brand added, “We appreciate the continued support of our investors as we look forward to filing our NDA currently targeted for early 2015.”
In 2012, the European Medicines Agency suspended the Marketing Authorization for calcitonin nasal spray and limited the duration of use of other calcitonin products, due to a purported association with cancer. In a plenary poster session at the 2013 American Society of Bone and Mineral Research (ASBMR) Annual Meeting, Tarsa presented a new meta-analysis based on 24 randomized, controlled calcitonin trials showing that salmon calcitonin does not appear to be associated with an increased risk of cancer, At the 2012 ASBMR Annual Meeting, Tarsa presented clinical data from two one-year studies that enrolled nearly 700 postmenopausal women and reported there was no carcinogenicity signal for its oral calcitonin.
The FDA’s “Questions and Answers: Changes to the Indicated Population for Miacalcin (calcitonin-salmon)”issued onMarch 11, 2014, reported that “The FDA’s review of these products found there is no conclusive evidence of a causal relationship between the use of these products (calcitonin) and cancer…We recommend that health care professionals assess a patient’s need for osteoporosis therapy, as well as the benefits and risks of available treatments.”
Mr. LaBella brings more than 30 years of diverse hands-on experience in managing R&D, clinical operations and regulatory affairs at leading biopharmaceutical companies and contract research organizations. He previously held positions of increasing responsibility at Insmed, Cardiokine, Pharmanet, Medex, Watson, Circa, Bolar and Sandoz.
“I have had the pleasure of working with Nick in the past and am delighted he will be leading the charge as we prepare to file the NDA submission for Ostora,” said Mr. Brand. “Nick’s varied clinical experience and past success in managing regulatory submissions make him well-suited for this important role.”
About Tarsa Therapeutics
Tarsa is developing Ostora, a novel oral formulation of calcitonin for the treatment and prevention of postmenopausal osteoporosis. This product has the potential to be the first approved oral calcitonin, a natural hormone with a long history of safety and efficacy as an osteoporosis therapy. Tarsa is based in Philadelphia, PA. For more information, visit www.tarsatherapeutics.com.
BLL Partners, LLC