Replies to post #97264 on Biotech Values

[DewDiligence]

Denosumab BLA for treatment of bone mets gets priority review with PDUFA date of 11/18/10:

http://finance.yahoo.com/news/FDA-Grants-Priority-Review-prnews-2899124803.html?x=0&.v=1

The phase-3 data to support this BLA includes approximately 6,000 patients in multiple kinds of cancer—see the first three rows of the table in #msg-51295923.

[DewDiligence]

Denosumab Phase-3 Scorecard

[Trial for prevention of bone mets in CRPC completed.]


The phase-3 denosumab program is one of the largest ever conducted
for any drug by any company. All told, there are 22 phase-3 trials
(although some are open-label extension trials to assess long-term
safety that are effectively phase-4’s). The following table includes the
most consequential phase-3 trials; they fall into four main groups:
metastatic cancer/treatment of bone mets; metastatic cancer/prevention
of bone mets; preservation of bone health in non-metastatic cancer; and
postmenopausal osteoporosis.

 
                            Primary   No. of  Completion   
 Indication         Comprtr Endpoint Patients   Date*    Outcome  Link   
  
 Metastatic cancer – treatment of bone metastases 
 Breast cancer      Zometa   TTFSE     2,049   compltd   superior http://clinicaltrials.gov/ct2/show/NCT00321464   
 CRPC               Zometa   TTFSE     1,904   compltd   superior http://clinicaltrials.gov/ct2/show/NCT00321620   
 Misc. cancers      Zometa   TTFSE     1,779   compltd   non-infr http://clinicaltrials.gov/ct2/show/NCT00330759   
  
 Metastatic cancer – prevention of bone metastases  
 CRPC               placebo  PFS       1,435   compltd   superior http://clinicaltrials.gov/ct2/show/NCT00286091   
    
 Non-metastatic cancer – preservation of bone health  
 Breast cancer      placebo† TTFF      2,800     1Q12      n/a    http://clinicaltrials.gov/ct2/show/NCT00556374   
 Prostate cancer    placebo‡ BMD       1,468   compltd   superior http://clinicaltrials.gov/ct2/show/NCT00089674   
 BCa w osteopenia   placebo  bone loss   252   compltd   superior http://clinicaltrials.gov/ct2/show/NCT00089661   
      
 Treatment/prevention of post-menopausal osteoporosis 
 1-line osteoprsis  placebo  fractures 7,200   compltd   superior http://clinicaltrials.gov/ct2/show/NCT00089791   
 1-line osteoprsis  Fosamax  BMD       1,189   compltd   superior http://clinicaltrials.gov/ct2/show/NCT00330460   
 2-line osteoprsis  Boniva   BMD         800     1Q11      n/a    http://clinicaltrials.gov/ct2/show/NCT00936897   
 Osteopenia         placebo  BMD         332   compltd   superior http://clinicaltrials.gov/ct2/show/NCT00091793   
 Fosamax switch     Actonel  BMD         800     3Q11      n/a    http://clinicaltrials.gov/ct2/show/NCT00919711   
 Fosamax switch     placebo  BMD         504   compltd   superior http://clinicaltrials.gov/ct2/show/NCT00377819 

*For analysis of primary endpoint.
†All patients receive an aromatase inhibitor.
‡All patients receive androgen-deprivation therapy.