Monday, December 17, 2007

Amgen: Denosumab, Positive PIII Results

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).
Looking at the AMGN clinical trails site (which is a great site by the way!) it appears as though there are seven additional ongoing Phase III denosumab studies, two of which are still recruiting. An NDA is planned for filing in 2009. Some believe that denosumab could garner upwards of $2B per year; needless to say that would certainly turn about the fortunes of the battered share price and if AMG785, a Sclerostin antibody, continues to proceed through its Phase I trial could function to reinforce Amgen’s potential dominance in bone mineral density for many years to come. Taking a look at the 5-year chart I am wondering if this does not present approaching perhaps the best buying opportunity in more than five years, though a bottom does not yet look apparent? Not that this is investment advice of any kind…

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