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CHMP Recommends Authorization to Market Preotact (PREOS) in Europe
SALT LAKE CITY, UT -- February 23, 2006 -- NPS Pharmaceuticals, Inc. and its partner Nycomed announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending authorization for Nycomed to market Preotact® (parathyroid hormone [rDNA origin] for injection) in the European Union. Preotact is the European brand name for PREOS® which NPS licensed to Nycomed in 2004 for development and marketing in Europe. PREOS/Preotact has been studied by NPS for the treatment of osteoporosis in postmenopausal women.
The CHMP recommendation is the last step prior to receipt of marketing authorization by the EMEA. Nycomed anticipates that the European Commission (EC) will ratify the CHMP opinion and issue a marketing authorization during the second quarter of 2006. If granted, Nycomed expects to be ready to launch Preotact in Europe during the second half of 2006. EU marketing authorization is valid in all 25 member states of the European Union. NPS Pharmaceuticals has filed a new drug application for clearance to market PREOS in the U.S. with the U.S. Food and Drug Administration. The application is currently under review by the FDA.
"We congratulate Nycomed on reaching this regulatory milestone and look forward to the launch of Preotact in Europe later this year. With 20 million women in Europe suffering from osteoporosis, Preotact represents an important new therapeutic option for these patients," said Hunter Jackson, Ph.D., NPS chairman and CEO.
"Preotact will be an important drug for Nycomed. The CHMP's positive opinion confirms the therapeutic value of Preotact," said Hakan Bjorklund, Nycomed CEO.
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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