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news.NPS Pharmaceuticals shares have slipped 2% after it revealed that it will delay the filing of a new drug application for its Nycomed co-developed osteoporosis drug candidate, Preos.
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NPS is extending the time it will take to prepare the new drug application (NDA) 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.
Nycomed intends to submit a marketing authorization application in Europe in March for approval to sell Preotact (the European brand name for Preos), and NPS and Nycomed are cooperating to meet the submission deadline designated by the European Medicines Agency.
US requirements are more extensive, however, so 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 US marketing application.
“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,” said Dr Hunter Jackson, chairman, president, and CEO of NPS.
“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 US and in Europe, which will allow us to achieve a timely and coordinated global Preos launch,” he continued.