Biotech Values

[DewDiligence]

Re: Liver tox in ITMN-191 phase-2b trial

I’ve been tempted to buy ITMN lately, and now I’m glad I held off. Liver tox is never a good thing in a drug to treat a liver disease. Even if ITMN-191 shows no tox in the lower-dose arms of the phase-2b study, the problems encountered in the terminated 900mg BID arm might induce regulators to require Roche to test TID as well as BID dosing in phase-3.

Moreover, the observed liver tox in the phase-2b trial calls into the question Roche’s ritonavir-boosting program for ITMN-191 insofar as ritonavir has liver-tox issues of its own. From the FDA label for ritonavir:

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

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.

Under the circumstances, I think ITMN investors were fortunate to get off with only a 16% haircut today.