Biotech Values

[ghmm]

Q2 2009 Earnings Call/PR Notes

191/HCV
. 6 month rat and 9 month monkey tox studies completed (no significant drug related findings). Necessary preclinical data for both Phase 2 & 3 as currently envisioned.
. Completed Phase 1 safety study of ritonavir PK showed marked improvement (no remarkable safety findings).
. INFORM Study patients enrollment "virtually completed" for all cohorts, data presented to AASLD 11/3/09
. Roche formulation efforts on 191 (outside of addition of ritonavir) are still ongoing
. Ritonavir addition could result in better results and for down-the-road possibly a smaller mass pill for use in combo regimen (as DD pointed out). Were looking at it even before SGP presented their data. Ritonavir AE's at therapeutic dose (600mg BID) has some overlap with 191 (GI effect) but aren't seen at boosting dose (100mg BID) didn't see any in initial study.
. If ritonavir addition shows promise may be possible to incorporate in current and planned studies (both triple combo and future INFORM studies) with minimal delay

Pirfenidone/IPF
. Hired sales & Marketing VP (was consulting with company for past year). Incrementally build infrastructure (Sales reps won't be hired before approval).
. Pre submission meeting with EMEA July '09 (characterized as successful)
. 520 improves AUC but does not increase C-max think will improve therapeutic index (dosing).
. Build-3 (Bosentan) in IPF final event expected year end.
. Partnership talk primarily for EU

Of 100 million R&D Guidance ~60% Pirfenidone, ~35% 191 (1/3 share with Roche paying 2/3), ~5% ITMN-520

Upcoming Events/Milestones
. 8 '09 Roche initiating Phase 2B of 191 (R7227) should be posted to clinicaltrials.gov (20 million milestone)
. 8/12/09 10:30am Presentation Canaccord Adams 29th Annual Global Growth Conference (Dan Welch)
. Q3 '09 Initiate Phase 1B MAD study of ritonavir + 191 (QD & BID daily) + PEG/Riba
. 9/14/09 European Respiratory Society (ERS) Annual Congress presentation on Pirfenidone (Primarily focus on Safety profile)
. 11/3/09 INFORM-1 presentations at AASLD
. Q4 '09 NDA Submission for Pirfenidone (1+ Quarter delay from prior guidance)
. Q1 '10 MAA Submission for Pirfenidone
. Q1 '10 RVR Data from 12 week regimen of 191 (1+ month delay from prior guidance)