From my understanding Amgen (NASDAQ:AMGN) is manufacturing denosumab (AMG162) at the Longmont, CO facility and announced results from the first Phase III pivotal study of the monoclonal antibodies effect on bone density across the skeleton in women with non-metastatic breast cancer who were receiving adjuvant Aromatase Inhibitor therapy (AI’s lower the amount of estrogen in post-menopausal women who have hormone-receptor-positive breast cancer). Bone loss is an adverse effect of AI therapy. Results from the Phase III study demonstrated that denosumab increased bone mineral density and cortical bone worsened by AI therapy.
Denosumab is the first fully human monoclonal antibody in late stage clinical development that specifically targets Rank Ligand, the essential mediator of osteoclasts by working to inhibit all stages of osteoclast activity. Rank Ligand is found in all parts of trabecular and cortical bone and Rank Ligand inhibition represents a highly targeted and specific approach to treating osteoclast-mediated bone destruction.
The competitive landscape for denosumab’s blockbuster potential is a fierce $7B/yr osteroporosis market led by:
- Novartis’ (NYSE: NVS) Reclast®/Zometa® ($1.3B 2006 sales, though this is for all indications of the drug), and
- Merck’s (NYSE: MRK) now off patent Fosamax ($1.4B 2007e).
If you enjoyed this post get free email updates (here).