Tarsa Therapeutics Targets 2012 NDA Submission for its Ostora

Tarsa Therapeutics has confirmed that it is planning to submit a New Drug Application (NDA) to the Food and Drug Administration (FDA) in the second half of 2012 for OSTORA™, the company’s oral recombinant salmon calcitonin tablet for the treatment of postmenopausal osteoporosis. This follows a formal pre-NDA dialogue with the FDA that verified the results from Tarsa’s Phase III ORACAL trial and the requirements for regulatory approval, including agreement on key elements of the submission. The study design and specific endpoints had previously been agreed in a Special Protocol Assessment with the FDA.

“Our recent dialogue with the FDA was very productive and we are on track to submit an NDA for OSTORA as a treatment for postmenopausal osteoporosis in the second half of 2012,” noted David Brand, Chief Executive Officer of Tarsa, “Our revised timeline for filing the NDA partly reflects Emisphere Technologies’ recent report of negative Phase III trial results for their oral calcitonin product. This development affords us the time to ensure that we assemble the highest quality NDA submission with the goal of maximising our chances for timely regulatory review and approval.”

At the 2011 Annual Meeting of the American Society for Bone and Mineral Research earlier this year, Tarsa reported positive efficacy and safety results from its year-long Phase III ORACAL trial showing that OSTORA achieved all of the trial’s efficacy endpoints and demonstrated statistically significant superiority to both placebo and nasal calcitonin spray in increasing bone mass density at the lumbar spine. In this trial, the safety profile of OSTORA did not substantially differ from nasal calcitonin or placebo and the majority of adverse events were mild or moderate.

Tarsa’s oral calcitonin is also being assessed in a one-year double-blind Phase II study comparing the OSTORA tablet 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 commercialisation rights to Unigene’s oral calcitonin product, with the exception of China.

About Tarsa Therapeutics

Tarsa Therapeutics is a venture-backed clinical stage biotechnology company developing OSTORA™, an oral formulation of calcitonin for the treatment and prevention of postmenopausal osteoporosis. Calcitonin has a long history of safety and efficacy and availability of an oral form is expected to generate wider use. Tarsa has reported positive efficacy and safety results from the Phase III ORACAL trial of its oral calcitonin tablet in the treatment of postmenopausal osteoporosis, and a Phase II osteoporosis prevention trial is underway. Tarsa is based in Philadelphia, PA. For more information, visit www.tarsatherapeutics.com.

Tarsa Therapeutics, Inc.

Tarsa Therapeutics, Inc.
Osteoporosis

Downloads

DownloadFull Press Release

Latest News

Alliance Pharma acquires Nizoral rights in APAC region

Alliance Pharma plc (AIM: APH), the specialty pharmaceutical company, is pleased to announce that it has agreed to acquire exclusive marketing rights to Nizoral, a medical, anti-dandruff shampoo brand, in Asia-Pacific from Janssen Pharmaceutica NV.

Alliance Pharma receives positive opinion for Diclectin

Alliance Pharma plc (AIM: APH), the specialty pharmaceutical company, announces that, following discussions with the Medicines and Healthcare products Regulatory Agency and the Commission on Human Medicines, the Marketing Authorisation Application for Diclectin® is now considered approvable.

Wilson Therapeutics AB announces public offer from Alexion Pharmaceuticals

Alexion Pharmaceuticals, Inc., has today, through Alexion Pharma Nordics Holding AB, announced a public cash offer to Wilson Therapeutics’ shareholders for a consideration of SEK 232 per Wilson Therapeutics share in cash (the “Offer”), which corresponds to a total offer value of approximately SEK 6,564 million, based on 28,292,272 shares outstanding.

Clinical study supports the use of Cheetah Medical's technologies

Cheetah Medical, a leader in non-invasive hemodynamic monitoring, has announced the publication of a major clinical study designed to evaluate stroke volume guided resuscitation in ICU patients with severe sepsis and septic shock

Vertos Medical Secures $28m in Latest Round of Funding

Vertos Medical Inc., a leader in the minimally invasive treatment of lumbar spinal stenosis has announced that it has completed a $28 million financing round.

VitalConnect Announces Closure of $33m Series C Financing

VitalConnect, a leader in medical-grade wearable biosensor systems, has announced that it has closed a Series C Preferred Stock equity financing round of $33 million led by new investors MVM Life Science Partners and Baxter.