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Osteoporosis
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my personal edition > osteoporosis > news
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DGNews
European Commission Issues Marketing Authorization for Preotact (Parathyroid Hormone for Injection)
Therapy Approved for the Treatment of Postmenopausal Osteoporosis
SALT LAKE CITY, U.T., and ROSKILDE, DENMARK -- April 26, 2006 -- NPS Pharmaceuticals, Inc. and its partner Nycomed announced today that the European Commission has granted marketing authorization for Preotact (parathyroid hormone [rDNA origin] for injection). Preotact is the European brand name for Preos which NPS licensed to Nycomed in 2004 for development and marketing in Europe.
The EMEA approved Preotact for treatment of postmenopausal women with osteoporosis at high risk for fractures. More information will be available in the coming days on the EMEA website at http://www.emea.eu.int.
"We congratulate Nycomed on reaching this major milestone and look forward to the launch of Preotact in Europe later this year," said Hunter Jackson, Ph.D., NPS chairman and CEO. "This is a significant event for NPS and our partner Nycomed and for the women who will benefit from its efficacy advantages."
"Preotact is a valuable addition to our osteoporosis product portfolio. We are gratified by the European Commission's agreeing that Preotact provides a safe, effective, and user-friendly treatment option for patients suffering from post menopausal osteoporosis." said Hakan Bjorklund, Nycomed CEO.
Nycomed submitted the marketing authorization application for Preotact to the European Medicines Evaluation Agency (EMEA) in March, 2006. The marketing authorization for Preotact is valid in all 25 member states of the European Union. Nycomed is now preparing for the pan-European launch of Preotact, scheduled for second half of 2006. NPS Pharmaceuticals filed a new drug application for clearance to market Preos in the U.S. with the U.S. Food and Drug Administration in May of 2005 and received an approvable letter in March of 2005.
About the Product
Preos/Preotact is recombinant human parathyroid hormone. NPS has studied Preos in a number of clinical settings to document its safety and effects on bone. The pivotal Phase 3 study, known as TOP (Treatment of Osteoporosis with PTH), was a multi-center, randomized, double-blind and placebo-controlled clinical trial designed to evaluate the potential of PTH to reduce the risk of first and subsequent vertebral fractures in post-menopausal women.
In the TOP study Preos demonstrated a statistically significant reduction in the risk of new vertebral fractures in women with and without pre-existing osteoporosis-related fractures. Results from the TOP study have been the foundation of both the E.U. and the U.S. marketing authorization applications.
SOURCE: NPS Pharmaceuticals, Inc.
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