Osteoporosis drug being assessed

NPS Pharmaceuticals, of Salt Lake City, US, and its European partner, Nycomed, have received confirmation from the European Medicines Agency (EMEA) that assessment of the market authorization application (MAA) for Preotact has begun. Preotact is the European trade name for Preos (parathyroid hormone), the NPS drug candidate being developed for the treatment of postmenopausal osteoporosis.

Nycomed submitted the MAA for Preotact on March 11. The application will be assessed under the EMEA's centralised approval procedure, which, following an approval, grants rights to market the applicant's product in all EU countries. NPS is in the final stages of preparing its new drug application (NDA) for Preos to be submitted to the FDA for U.S. marketing approval.

'We're pleased with the acceptance of Nycomed's marketing application for Preotact,' said Dr Hunter Jackson, chairman, ceo, and president of NPS. 'In our view the European application and the NDA we're preparing for Preos are strongly supportive of regulatory approval. We look forward to continuing our work with Nycomed to prepare for and coordinate a global launch of Preotact and Preos.'

About Preos

Preos is recombinant full-length human parathyroid hormone, PTH (1-84). NPS has studied it in a number of clinical settings to assess its safety and its effect on bone. The pivotal Phase III study, known as TOP (Treatment of Osteoporosis with PTH), was a multi-centre, randomised, 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 are the foundation of the US and European marketing applications.