Replies to post #95070 on Biotech Values

[iwfal]

DNDN -

So.... where exactly do you see only a "marginal" effect?

I suspect he is making reference to the fact that 50% or more of drugs approved in onc with survival data have survival HR<0.75. (My guesstimate based upon previous scans through FDA approvals - but if you want to confirm try a google search on fda approvals for survival in cancer). And, in fact, in the recent FDA discussion of the Tarceva data (where the FDA overruled the ODAC) they made reference to wanting to see around 0.8 or better. Thus the IMPACT HR is on the high side.

Obviously there are other considerations as well:

a) low tox profile (e.g. some drugs, like Alimta, do quite well even with marginal efficacy because of low tox.)

b) number of indications (are there any blockbusters in onc with only one indication - my guess is that there are, but virtually all will be with survival HRs substantially better than 0.75.)


PS A technical consideration is that Prostate Cancer trials inevitably suffers from a disadvantage over trials in other cancers with regard to survival HR - Prostate Cancer has a long median survival and is in the elderly and thus the treatment HR is washed out by the high die-of-old-age rate. My guesstimate is that cancer specific mortality for Provenge is actually in the middle of the pack, or somewhat better, when compared to other onc drugs using "cancer specific mortality" (which is tricky - since a lot of cancer mortality is not directly attributable to the cancer (see the below cite - which is one of many I have seen)).


http://www.ncbi.nlm.nih.gov/pubmed/16489536

[jessellivermore]

Dear Trond..

Forgive my lack of clarity. I was using "marginal" in a subjective sense when what I should of said is Provenge is not a cure.

My post was pretty spur of the moment. I have a little more time at present and will attempt to clarify my scepticism.

DNDN has stated they will charge somewhere in the $90K range for their treatment..This brings me back to Tissue Repair I seem to remember (Dew may have notes) TR was planning on charging a more modest $20K for their cartiledge cure. There were lots of bum knees running around..whoops, perhaps not running. The potential revenues were staggering...Then Blue Shield after stalling for about nine months simply decided they were not convinced, despite FDA OK, the treatment was beneficial, and refused to cover the treatment. There was some bickering in the Orthopedic field.. but without insurance paying for this the company's PPS went into a steady decline...

If I catch the drift of the governments Patient Protection Act, I do not see them wasting resources on this very expensive treatment. You can forget about Europe, Asia and Africa, they are still trying to combat more important issues. This is Gucci Medicine... If you want it most people would have to sell their house...I predict they do not sell the house...