Replies to post #94128 on Biotech Values

[DewDiligence]

(ITMN) More dumbness in print from The Motley Fool—a perpetual source of such finds:

http://www.fool.com/investing/high-growth/2010/04/14/oops-this-drug-works-too-well.aspx

Top-line data from a phase 2b study of their hepatitis C drug danoprevir suggest that the drug works well -- when combined with Roche's Pegasys and Copegus, all three doses had cure rates near 90% compared with 43% for placebo.

Wrong! EVR, the metric cited above, is not a cure rate or even a proxy for such. You would think someone writing professionally about drugs for HCV would at least know the difference between EVR and SVR.

[DewDiligence]

ITMN:

At first look I think the results look very good and the safety is much, much better then I (and I suspect others) feared!

I agree that the safety results reported today are not as bad as they might have been, but I do not agree that the results are good or even satisfactory.

When one considers the ritonavir boosting going forward and 10-25% the dose I suspect the drug is FAR from "dead"

Let’s bear in mind that ritonavir is not a pristine drug from a safety and tolerability standpoint*; hence, it remains to be seen how much benefit will accrue from cutting the dose of ITMN-191 and adding ritonavir. If ritonavir boosting were likely to be a winning approach, Roche and ITMN would presumably have done it from the start.

*From the FDA label for ritonavir:

Hepatic transaminase elevations exceeding 5 times the upper limit of normal, clinical hepatitis, and jaundice have occurred in patients receiving NORVIR [ritonavir] alone or in combination with other antiretroviral drugs… There may be an increased risk for transaminase elevations in patients with underlying hepatitis B or C. Therefore, caution should be exercised when administering NORVIR to patients with pre-existing liver diseases, liver enzyme abnormalities, or hepatitis. Increased AST/ALT monitoring should be considered in these patients, especially during the first three months of NORVIR treatment.

http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020659s043,020945s023lbl.pdf