Replies to post #111065 on Biotech Values

[DewDiligence]

Sales projections for denosumab/Prolia/Xgeva are all over the map. Some analysts expect peak annual sales in all indications to amount to a mere $2B, while others foresee peak sales of $12B or more. The latter figure would likely make denosumab the largest-selling drug of all time.

[DewDiligence]

Xgeva sBLA for prevention of CRPC bone mets has a PDUFA date of 4/26/12: (i.e. this is a standard FDA review):

http://finance.yahoo.com/news/Amgen-Announces-PDUFA-Date-prnews-2216452933.html?x=0&.v=1

The sBLA was submitted on 6/27/11, so this is a standard 10-month review.

Xgeva is already approved for preventing skeletal-related events in patients who already have bone mets (#msg-56882220).

The newly sought indication corresponds to the fourth row in the table in #msg-57938233.

An sBLA for preventing bone mets in metastatic breast cancer will be submitted much later, pending data from the phase-3 trial (see fifth row in #msg-57938233).

[DewDiligence]

NICE changes its mind on endorsement of Xgeva for metastatic CRPC:

http://in.reuters.com/article/2012/06/11/us-amgen-britain-idINBRE85A1M020120611

NICE’s original decision endorsing Xgeva was made in Mar 2012. Note: this is the CRPC treatment of bone mets indication for which Xgeva is already approved in most countries—not the prevention of bone mets indication in which Xgeva received a CRL in Apr 2012 (#msg-74907445).