InterMune Inc. (ITMN)

[ghmm]

You did a very nice job summarizing the INFORM study. I got the same impression on interest in it (based on the battery of initial questions on that study at the start of the call). I would add that Dan Welch said if things progress on schedule and the data look promising full SVR data from a phase 2 study would be available before telaprevir is launched which could make for interesting market dynamics. Also, the INFORM-1 study would likely be followed by several other INFORM studies upon completion. Though he did not specifically indicate what they may be he did disclose trying regimes with and without PEG (though at least in some keeping Ribavirin).

There were several notable remarks on Pirfenidone in the call (I really like the pure Q&A format of that conference and in general found the questions more substantive then other conferences for all presenting companies I heard not just ITMN).

I am really impressed thus far with Dan Welch. I liked him from early on but his past few conferences and what he's done with the hand he has been dealt has been to more than my satisfaction. Now we just need positive Pirfenidone data!

I am not sure I will update the ReadMeFirst but I would be happy to elaborate on any questions people may have and I will post a few updates below:

Up Coming Milestones
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Q4 ’08: Report Top-line data on at least 5 cohorts in the 191 Combo study.
Jan-Feb ’09: Report Top-line data on CAPACITY study of Pirfenidone
1H ’09: INFORM-1 study results
1H ’09: Initiate Phase 2B R7227 (ITMN-191) Combination study with Pegasys/Copegasys


HCV Programs
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Phase 1 results
Phase 1A #msg-33270294
Phase 1B #msg-33270341 and #msg-33270355

R7227 (ITMN-191) Phase 2B program likely to:
1. Test both 2x and 3x regimens of R7227.
2. International
3. SVR will be the end point
4. Expect similar to other protease inhibitor studies

. R7227 will be lead by Roche going forward.
. 12 week tox studies longest animal studies that we are aware of being successfully completed (longer studies are likely in progress and perhaps recently completed but not disclosed)

Other HCV Work
1. ITMN-5489 (non-macrocyclic) #msg-33270262
2. 2nd generation (macrocyclic) described as VERY interesting are in earlier stages of development
3. Preclinical work combining R7227 and R1626 or R7128 #msg-33270382
4. Helicase Program #msg-33270432

IPF/Pulmonary
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1. Pirfenidone results January/February ’09. FVC of 40-50% reduction in rate of decline compared to placebo is primary end point. Main secondary end point PFS (FVC is part of composite defining this).
2. Japanese approval 10/16/08 marketed as Pirespa
3. Early stage programs for Pirfenidone analogs as well as other Pulmonology targets

Financials at end of Q3 2008
. 185 millions cash and securities
. 170 million in 2 convertible notes (half due 2011 $21.63 conversion and .25 interest, half 2015 $18.88 conversion and 5% interest) total 8.4 million shares for both
. A number of (IMO) nuisance suits have been filed in the past couple months regarding Actimmune use. My expectation is that this will take a year or so to drag on before settling.