Biotech Values

[DewDiligence]

Europe’s CHMP approved Prolia (denosumab) for two indications:

• treatment of postmenopausal osteoporosis; and

• treatment of bone loss from hormone ablation in non-metastatic prostate cancer.

http://finance.yahoo.com/news/Amgen-Receives-CHMP-Positive-prnews-200827939.html?x=0&.v=1

In the EU, the marketing of Prolia will be split between AMGN and GSK
according to the indication: GSK in osteoporosis and AMGN in oncology.

In the US, Prolia received a Complete Response Letter for the indication in the first bullet above and a variation of the second bullet above that includes non-metastatic breast cancer as well as prostate cancer (#msg-42814924, #msg-41722030).