PREOS NEW DRUG APPLICATION ACCEPTED FOR REVIEW BY FDA

NPS Pharmaceuticals has announced that as of July 9, 2005, the FDA has accepted for review the company's new drug application (NDA) to market Preos (parathyroid hormone) for the treatment of osteoporosis in postmenopausal women.

NPS submitted the application May 10, 2005, and the FDA has now made a threshold determination that the Preos NDA is sufficiently complete to permit a substantive review.

Clinical results in the NDA are based upon data from 13 separate studies including an international multicenter Phase III trial of approximately 2,600 postmenopausal osteoporotic women who were randomized to receive either a daily subcutaneous injection of 100 micrograms of Preos or placebo, in addition to daily calcium and vitamin D supplements.