NPS update on Preos manufacturing.(NPS Pharmaceuticals Inc.)(Brief Article)

2002 JUL 18 - (NewsRx.com & NewsRx.net) -- NPS Pharmaceuticals, Inc., (NPSP) provided additional information regarding the problem with the manufacture of clinical supplies of Preos, its proprietary drug candidate for the treatment of osteoporosis.

NPS is currently conducting a phase III clinical study of Preos in approximately 2600 women with osteoporosis. Patients participating in the study receive a daily injection using an injector pen which is designed to contain a 2-week supply of drug or placebo. On May 15, 2002, NPS reported that clinical supplies of Preos were not able to be produced that met the company's release specifications, and that the manufacturer and the company were conducting an extensive review of fill and finish procedures to assess and correct the problem. The company notes that clinical supplies of Preos currently in use by patients in the phase III trial have met all release specifications. Furthermore, ongoing monitoring of these supplies indicates that none of this material has deteriorated in quality, and testing of reference samples retained by NPS confirms the quality of previously released material. However, these supplies are only sufficient to allow the trial to proceed without ...