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NPS, Nycomed get committee OK to market Preotact/Preos parathyroid hormone in Europe
By Lisa Kerner
Erie, Pa., Feb. 23 - NPS Pharmaceuticals, Inc. and its partner Nycomed announced that the Committee for Medicinal Products for Human Use 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, according to a company news release.
Preos/Preotact, recombinant human parathyroid hormone, has been studied by NPS for the treatment of osteoporosis in postmenopausal women.
As a result of the committee recommendation, Nycomed anticipates that the European Commission will 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.
NPS said it has filed a New Drug Application, which is under review, with the Food and Drug Administration to market Preos in the United States.
"We congratulate Nycomed on reaching this regulatory milestone and look forward to the launch of Preotact in Europe later this year," NPS chairman and chief executive officer Hunter Jackson said in the release.
"With 20 million women in Europe suffering from osteoporosis, Preotact represents an important new therapeutic option for these patients," he said in the release.
NPS discovers, develops and commercializes small molecules and recombinant proteins as drugs for the treatment of metabolic, bone and mineral and central nervous system disorders. The company is located in Salt Lake City.
Nycomed is a European pharmaceutical company based in Roskilde, Denmark.
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