InterMune Inc. (ITMN): Some Notes from today’s LCM presen...

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Tuesday, 11/18/2008 7:04:23 PM

Tuesday, November 18, 2008 7:04:23 PM

Some Notes from today’s LCM presentation

IPF/Pirfenidone
1. 95% of CAPACITY patients “volunteered for enrollment” in extension study (RECAP).
2. (Question) if doesn’t work out resize company. Left with 140-150 million (depending on Roche milestones), 191, other targets would move in that direction (would be much, much smaller company but would survive).
3. (Question) What if only 1 of 2 studies meets metrics? Depends on how close other is and nuances around it. If close enough expect would still file. Would not be first time a deadly disease with no approved therapy filed would probably be advisory panel. Analysis planned on pulled data but to succeed each stands on own.
4. FVC+PFS succeeding think it is smooth. If only have FVC think it still has chance especially if other secondaries trend don’t think they would even have to be stat significant.

HCV/191
1. Initiate Phase 2 191+SOC in 1H ’09 (no further color)
*2. Triple Combo Study starting at 300mg
[We know there will be at least five cohorts, So if one assumes things matched the monotherapy study we have this:
1: 100mg q8 (300 mg total)
2: 200mg q12 (400 mg total)
3: 200mg q8 (600mg total)
There was a non-responder cohort at 600mg (300mg q12) but this study does not have a non-responder cohort. So guessing going forward.
4: either 300mg q12 (600mg total) or 400mg q12 (800mg total)
5: 300mg q8 (900mg total) or remote chance they do 400mg q8 (1200mg total)
They did test up to 1600mg in the SAD study