Request of Italian Marketer of Nasal Calcitonin Spray for Reexamination of Recent CHMP Recommendation Has Been Accepted
Study Slated for Presentation at ASBMR 2012 Assesses Whether Tarsa’s Oral Calcitonin Was Associated with Increased Cancer Risk in Two Year-Long Postmenopausal Osteoporosis Trials
Second ASBMR Presentation Discusses Results of Phase II Trial of Tarsa’s Oral Calcitonin in the Prevention of Postmenopausal Osteoporosis
PHILADELPHIA, PA – October 12, 2012 — Tarsa Therapeutics today announced an agreement in principle with Therapicon® Slr to provide consulting assistance to the Italian firm in its challenge to the recent recommendation by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to limit the use of calcitonin-containing medicines. Therapicon’s request for a reexamination of the recommendation has been acknowledged by the CHMP, and a timetable for the reexamination process has been set.
On July 19, 2012, the EMA announced that the CHMP had completed a review of the benefits and risks of calcitonin-containing medicines and had concluded that there was evidence of a small increased risk of cancer with long-term use of these medications, which have been approved and commercially available in Europe and the U.S. since 1973. The CHMP recommended that long-term use of calcitonin be curtailed, including its use in the treatment of osteoporosis. For short-term use the benefit/risk profile was found to be favorable.
“Calcitonin-containing medicines have a 30-year record of safe use by millions of patients worldwide, with scant evidence of any increased cancer risk,” noted Dr. Paolo Veronesi, CEO and R&D Director of Therapicon. “Our scientists believe there are serious flaws in the analyses cited by the CHMP in their report. We look forward to the assistance of Tarsa and its experts as we work with the CHMP to re-examine this issue.”
Separately, Tarsa announced that two studies of its oral calcitonin have been accepted for presentation at the American Society for Bone and Mineral Research (ASBMR) 2012 Annual Meeting:
- One Year Use of Oral Recombinant Salmon Calcitonin is Not Associated with Increased Risk of Cancer
- Safety and Efficacy of Orally Administered Recombinant Salmon Calcitonin Tablets in the Prevention of Postmenopausal Osteoporosis in Women with Low Bone Mass: A Phase 2 Placebo-Controlled Trial.
Presentation abstracts are available to ASBMR members and registered conference participants atwww.asbmr.org/ItineraryBuilder/GettingStarted.aspx. ASBMR 2012 will take place October 12-15, 2012 in Minneapolis, MN.
David Brand, President and CEO of Tarsa, commented, “We believe that our oral calcitonin has the potential to provide a safe and effective new option for the millions of at-risk patients seeking to prevent and treat post-menopausal osteoporosis, a painful, crippling and sometimes fatal condition. We welcome the opportunity to support our colleagues at Therapicon in their challenge to the CHMP recommendation.”
Tarsa is developing its 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.
Therapicon® Srl develops and markets chemical and biological medicines designed to yield better therapeutic outcomes and improve patients’ compliance and lives. Its products, which include novel molecules, innovative drug delivery technologies and APl’s, target commonly occurring serious diseases. Therapicon’s wide range of capabilities includes innovative research programs, clinical development, industrial-scale manufacturing and commercial partnerships. For more information, visit www.therapicon.com.
About Tarsa Therapeutics
Tarsa is developing 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.
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