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Biotech / Medical : Biotech Valuation
CRSP 56.87-2.3%Dec 5 3:59 PM EST

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To: Biomaven who wrote (1810)10/8/2000 10:31:41 AM
From: hm  Read Replies (1) of 52153
 
Peter / smh

A couple more comments to throw into the pharmacogenetic discussion:

This is one of those concepts that intuitively makes so much sense that it tends not to get examined critically. Many fundamental issues have yet to be worked out in the real world. The key difficulties were already pointed out - the physician hassle factor, regulatory issues, and the economic implications for structuring a drug development portfolio. Legal liability issues shouldn't be underestimated either.

An example may help: a company develops a novel anti-depressant that has a significant efficacy advantage over gold standard treatment. The bad news is that the new drug has a 10% risk of serious liver toxicity. The good news is that the company has developed a test that will identify 95% of the patients at risk for liver toxicity. What will happen?

There is need for a more efficacious anti-depressant so there could be a very large market. However, from a regulatory standpoint, the drug will probably have a black box warning. It would also be more of a hassle to prescribe given the need to use the toxicity test, the safety issues, and the existence of many other choices. One could envisage guidelines putting the drug 2nd or 3rd line.

My guess is that, in the current environment, this new drug would see a slow launch and probably get limited use. For big pharma this isn't an attractive scenario. But for smaller companies (not to mention some patients) this might be a successful drug.

For all this, pharmacogenetics is still the future & will become increasing important in drug development & medical practice. But implementation is farther off than the hype would suggest. Oncology is probably the field to watch to track the progress.

My two cents
hm
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