Trends-in-Medicine| Publisher: | Stephen Snyder |
| Writers: | Lynne Peterson |
| Marta Weber | |
| Diana Woods | |
| Editors: | Kathleen Snyder |
| Betty Teel | |
Trends-in-Medicine has no financial connections with any pharmaceutical or medical device company. The information and opinions expressed have been compiled or arrived at from sources believed to be reliable and in good faith, but no liability is assumed for information contained in this newsletter.
Copyright© 2004
No articles may be reproduced without written permission of the publisher.
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American Society For Bone and Mineral Research (ASBMR)
Summary: In one-year Phase II data Amgen’s AMG- 162 beat placebo at all doses, and beat Merck’s Fosamax at all but the lowest dose. Amgen’s calcimimetic Sensipar (cinacalcet) needs more data for FDA approval in primary hyperparathyroidism, but it is being well accepted in the more limited, approved indications. Chugai’s nasal spray hPTH (1-34) is proceeding to a dose-finding Phase II trial, but patent issues with Lilly loom and safety questions remain. At three years Lilly’s Forteo continues to decrease fractures as well as alter progression of osteoporosis. The bisphosphenate marketing wars continue. Merck’s Fosamax beat out Proctor & Gamble’s Actonel on BMD in a head-tohead trial, but some sources believe Actonel may be a better pre-treatment for PTH. Johnson & Johnson/Alza is working on a transdermal patch delivery system for Forteo – Macroflex-ThPTH – which looks very interesting. Bad news is on the near horizon for Kyphon – a study to be published shows a 25% adjacent fracture risk within two months.
American College of Rheumatology
Summary: In RA: Numerous new agents are in development, but rheumatologists are most excited about BiogenIdec/Genentech/ Roche’s Rituxan in RA and SLE. Two Phase III trials of Bristol-Myers Squibb’s abatacept were positive, but rheumatologists still don’t know how to use it. In osteoporosis: The 18-month TOP trial of NPS Pharmaceuticals’ Preos met its primary endpoint, moving a second PTH closer to FDA approval. Pfizer’s nextgeneration SERM, lasoxifene, beat out Lilly’s Evista in a Phase II osteoporosis trial. New Cox-2s, including Merck’s Arcoxia and Novartis’s Prexige, are likely to be delayed while the FDA works out new guidelines for Cox-2 clinical trials. Merck offered little to differentiate Arcoxia from Vioxx, and hints of CV issues plague both Arcoxia and Prexige. The data on Amgen’s AMG-714 was not as positive as expected, and disappointing results were reported on Boehringer Ingelheim’s BIIL- 284, Genzyme/Cambridge Antibody’s CAT-192, Human Genome Sciences’ belimumab, and Novartis’s ABN-912.
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