Replies to post #85333 on Biotech Values

[DewDiligence]

Confusion re AMGN’s various Prolia BLA’s:

The text you bolded in your post suggests that you (and the Bloomberg author you quoted) may be confusing two distinct Prolia BLA submissions. This is the passage you bolded:

The FDA also wants Amgen to mount new clinical trials further investigating the use of the therapy in women with breast and prostate cancer…

Setting aside the sloppiness of the wording (which implies that AMGN is studying women with prostate cancer, LOL), the important point is that the above passage refers to the Prolia BLA for prevention of bone loss in patients with non-metastatic breast and prostate cancer undergoing hormone-ablation therapy. AMGN received a Complete Response Letter from the FDA in response to this BLA submission. The trials supporting this BLA are shown in the sixth and seventh rows of the table in #msg-41722030.

A separate Prolia BLA for reducing the incidence of bone metastases in patients with metastatic cancer has not yet been submitted and will not be submitted until mid 2010, pending the outcome of a trial in HRPC—the one shown in the third row in the table in #msg-41722030.

On AMGN’s 3Q09 CC, Roger Perlmutter (head of R&D) said that the data supporting the Prolia BLA for reducing the incidence of bone metastases in patients with metastatic cancer may conceivably satisfy the FDA’s request for additional safety data to support the BLA for preventing bone loss in patients with non-metastatic breast and prostate cancer undergoing hormone-ablation therapy. This is not likely, IMO, but possible; i.e. the FDA has not flat-out demanded new clinical trials for the bone loss/hormone-ablation-therapy BLA, as has been reported in some newswire stories.

The only Prolia indication in which the FDA has flat-out demanded new clinical trials is prevention (rather than treatment) of osteoporosis in postmenopausal women.