Replies to post #125213 on Biotech Values

[DewDiligence]

The FDA will approve a new drug well ahead of the PDUFA schedule when there is a compelling medical need. Roche’s Zelboraf (f/k/a PLX4032) and JNJ’s Zytiga are two such cases.

[DewDiligence]

Astonishing factoid: Zelboraf is Roche/Genentech’s first new cancer drug in seven years!

[DewDiligence]

FDA label for Zelboraf:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202429s000lbl.pdf

[DewDiligence]

Zelboraf’s retail price will be about $310/day ($56K for six months), according to the WSJ (http://online.wsj.com/article/SB10001424053111903639404576514084262209282.html ).

[DewDiligence]

Another company offering a BRAF V600E diagnostic:

http://finance.yahoo.com/news/Molecular-Response-Expands-bw-3796239069.html?x=0&.v=1

[mcbio]

The median survival (the length of time a patient lives after treatment) of patients receiving Zelboraf has not been reached (77 percent still living) while the median survival for those who received dacarbazine was 8 months (64 percent still living).

How are they unable to report median survival for the Zelboraf arm but able to report it for the DTIC arm when both arms still have patients living?

Separately, this DTIC OS data in advanced melanoma patients could have some implications for ARRY. Note that DTIC is the control arm in what I believe is at least a somewhat similar group of melanoma patients being tested in AZN's ongoing Phase 2 trial of selumetinib in advanced-stage melanoma patients (http://clinicaltrials.gov/ct2/show/NCT00936221?term=selumetinib&rank=37 ). That trial completed enrollment in March 2010, and I'm still not certain that the trial has actually completed. The clintrials entry was updated last in May and says May completion but it also says the trial is still ongoing as of that May update. At a minimum, we are talking 14 months that the study ran from time of full enrollment to completion. The big caveat is that it's difficult to compare data across trials and there's certainly no guarantee that 8 months OS for the DTIC-only arm will translate directly over to the selumetinib trial.

[DewDiligence]

CHMP approves Roche’s Zelboraf for melanoma:

http://www.bloomberg.com/news/2011-12-16/roche-s-zelboraf-melanoma-drug-wins-backing-of-eu-regulator-1-.html

The EU will rubber stamp the decision in 2-3 months.