Biotech Values

[DewDiligence]

Ipilimumab shows statsig OS in 1st-line metastatic melanoma:

http://finance.yahoo.com/news/Phase-III-Study-of-bw-1191929168.html?x=0&.v=1

These results are a freaking big deal, IMO. The ‘024’ study tested chemo ± Ipilimimuab in unresectable Stage III/IV melanoma (http://clinicaltrials.gov/ct2/show/NCT00324155?term=ipilimumab+melanoma&phase=2&rank=4 ). Full data will be reported at ASCO in June.

In the second-line setting, BMY has an Ipilimumab BLA pending based on the ‘020’ study with a PDUDA date of 3/26/11. An advisory panel for the second-line BLA was originally scheduled and was rescinded for unexplained reasons. An MAA is the EU is currently under review.