Biotech Values

[DewDiligence]

AMGN: The new PDUFA date for Prolia (denosumab) in osteoporosis indications is 7/25/10, six months from the Jan 2010 submission of AMGN’s response to the FDA’s CRL received in Oct 2009:

http://finance.yahoo.com/news/FDA-Classifies-ProliaTM-prnews-2110666215.html?x=0&.v=1

AMGN has previously stated that the Prolia BLA in cancer indications is still on track for (initial) submission during 1H10; however, today’s PR sounds wishy-washy on this score:

Amgen continues to work with the FDA to determine appropriate next steps regarding its indications for Prolia in the prevention of postmenopausal osteoporosis, as well as in the treatment and prevention of bone loss due to hormone ablation in breast and prostate cancer patients.

The FDA is once again a laggard insofar as Prolia has been approved by Europe’s CHMP for both osteoporosis and cancer indications (#msg-44690591). See #msg-46432335 for a “scorecard” of the various denosumab phase-3 trials and indications.