PreosTreatment for Osteoporosis
NPS Provides Update on Preos NDA Process and Timing
SALT LAKE CITY, February 7, 2005 -- NPS Pharmaceuticals, Inc. announced today that the company will extend the time it will take to prepare the U.S. new drug application (NDA) for its osteoporosis drug candidate Preos in light of European deadlines and filing requirements of its partner Nycomed, and the complex process of incorporating data from multiple clinical studies into different regulatory submission documents.
The company noted that Nycomed intends to submit a marketing authorization application in Europe next month for approval to sell Preotact (the European brand name for Preos or PTH), and that NPS and Nycomed are cooperating to meet the submission deadline designated by the European Medicines Agency. Because U.S. requirements are more extensive, NPS will submit its NDA following the Nycomed submission as soon as it has electronically formatted all of the additional documentation necessary for a successful U.S. marketing application.
Hunter Jackson, Ph.D., Chairman, President, and CEO of NPS, said, "We are nearing completion of the NDA for Preos and believe we have a very strong data package to support the approval of this investigational therapy for postmenopausal osteoporosis. Although we will extend our submission date beyond the end of February, we expect the delay will be brief and that the extra effort and time will facilitate productive regulatory reviews in the U.S. and in Europe, which will allow us to achieve a timely and coordinated global Preos launch."
Preos is recombinant full-length human parathyroid hormone (PTH 1-84). NPS has studied Preos in a number of clinical settings to assess its safety and its effect on bone. The pivotal Phase 3 study, known as TOP (Treatment of Osteoporosis with PTH), was a multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the potential of PTH (1-84) to reduce the risk of vertebral fractures in post-menopausal women. In the TOP study Preos demonstrated a statistically significant reduction in the risk of new or worsened vertebral fractures in women with and without osteoporosis-related fractures prior to entering the study. Results from the TOP study will be the foundation of the U.S. and European marketing applications.
About NPS Pharmaceuticals
NPS discovers, develops and intends to commercialize small molecules and recombinant proteins as drugs, primarily for the treatment of metabolic, bone and mineral, and central nervous system disorders. The company has drug candidates in various stages of clinical development backed by a strong discovery research effort.
For more information, please visit www.npsp.com.
Posted: February 2005
- NPS Updates Status of Preos NDA - March 29, 2006
- NPS Receives Approvable Letter for Preos NDA - March 10, 2006
- Preos New Drug Application Accepted for Review by FDA - July 11, 2005