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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?


To: NeuroInvestment who wrote (23485)4/18/2007 9:48:11 AM
From: scaram(o)uche  Respond to of 52153
 
Thanks Harry -- certain from the thread as a whole -- for your thoughts.

I once gave it some thought.... who should be responsible for labeling a medicine "me too!"? I came up with a large, low-compensation panel of FASEB-appointed sorts.

But my view of FDA is different than most.... I see good scientists who want to expedite new, safe medicines. And, again, this was an advisory committee, not FDA. The vote was trickle down from cardio thought honchos.... justifiable trickle down, imo.

Best! Rick



To: NeuroInvestment who wrote (23485)4/18/2007 9:51:02 AM
From: Biomaven  Read Replies (1) | Respond to of 52153
 
It actually drives me crazy when folks like Marcia Angell (ex-editor of the NEJM) dismiss "me-too" drugs out of hand. In many cases some "me-too" drug has emerged as best-in-class. (Think ranitidine replacing cimetidine; or Zocor and Lipitor vs. the earlier statins; or the later triptans compared with Sumatriptan).

The other issue is that you want many companies attacking the same class. If first and perhaps second to succeed take the entire pot, then that will reduce the number of candidate drugs, and if the leaders fall by the wayside then there could be a several year delay to the first drug in the class.

Note that the FDA's refusal to file for Factive in ABS was an earlier example of a double standard. The drug is clearly better than many on the market that have that label.

Peter



To: NeuroInvestment who wrote (23485)4/18/2007 9:33:15 PM
From: Robohogs  Respond to of 52153
 
I agree more emphasis should be placed on drugs for markets which have no good options.

There is a fundamental miscalculation, however, in thinking fewer me-too results in lower healthcare spending. When you have 3-4 drugs of a similar type, that gives the HMOs and prescription benefit managers and formularies much more control over pricing. Also, sometimes the me-too has very distinctive side effect profile.

Jon