(See prior ReadMe’s for general information and Actimmune information)
Competitive Landscape for IPF 1. Genzyme (collaboration with what was CAT) in Phase 1 2. Bosentan (Tracleer) from Actelion, Phase 2 failed in their endpoint proceeding with Phase III (BUILD-3) 390 patients, event-driven study (131 events needed defined as decreased FVC and DLCO, acute exacerbation, or death interim analysis with 62 events) randomized 2:1. 3. Imatinib (Gleevec), I believe it failed Phase 2 not sure of status going forward. 4. Etanercept (Enbrel), Phase 2 mixed results (no effect on endpoint; trend towards reduced disease progression) 5. Sildenafil (Phase 2) http://www.clinicaltrials.gov/ct/show/NCT00352482 6. Pipex (Tetrathiomolybdate) Phase I-II completed. Company filings say plans to initiate Phase 3. Phase i-II presented results #msg-19613632 7. FivePrime (Collaboration with J&J) http://tinyurl.com/yz444l 8. Fibrogen FG-3019 (for IPF) completed Phase 1 in patients (safe and well tolerated) http://www.fibrogen.com/uses/ipf.html 9. EmphyCorp N115 (ILD) http://emphycorp.com/ild.html 10. AlsoThalidomide being looked at, Others?
Pirfenidone
(See prior ReadMe’s for general and older information on Pirfenidone)
• IP Expansion and life-cycle management efforts underway since 2005
CAPACITY Trials, http://www.capacitytrials.com/ http://www.clinicaltrials.gov/ct/show/NCT00287729 http://www.clinicaltrials.gov/ct/show/NCT00287716 - Three Arm Study • Primary endpoint is change in forced vital capacity (FVC) after 72 weeks of treatment • Two concurrent, multi-national trials CAPACITY 1 and CAPACITY 2 • Randomized first patient April 27, 2006. Completed enrollment May, 2007. 779 total patients in 110 centers (North America and Europe). Results expected late 2008 or early 2009. Expansion of trials was targeting to enroll 720 (320 and 400). • Not pursuing partnership at this time • Differences between CAPACITY and Shionogi Phase 3 (Company presentations) Shionogi 250 patients, ours 779 (in 2 320 and 400 targeted in each of the studies not disclosed actual breakdown). Length Shionogi-52 ours 72 weeks. Dosing in Shionogi low dose 400mg TID high 600 TID, CAPACITY I-800mg TID, CAPACITY II 800mg and 400mg both TID, if account for avg. body weight of US/EU vs. Japan about 30mg/kg in each. Endpoint Shionogi change in Vital Capacity ours Change in Percent Predicted Forced Vital Capacity. Comparable measures of lung volume. Other difference is the patient population, Shionogi is Japanese ours is mainly NA and EU do not know of any metabolism difference in population or Pirfenidone between two groups. • Power: > 95% to detect 50% reduction of FVC decline and > 85% to deduct 40% reduction in FVC.
InterMune 191 / PI Program
(See prior ReadMe’s for general and older information on 191)
• Phase 1A Trial Information 1. One clinical trial site in Europe approximately 64 healthy volunteers, Single ascending dose. 2. First patient dosed early January 2007. Completed May 2007. 3. A significantly higher than anticipated plasma level of InterMune 191 was seen in patients, in dose cohorts where the drug was administered with food. We did explore the food effect purposely in the single ascending dose study. It was not explored at all doses, but at a selection of doses. And, yes, the results were consistent. 4. Plasma levels of 191 were observed in all dose groups in the SAD study 5. Range of potentially efficacious doses to examine in the multi-dose Phase Ib study identified. Doses in this range were well tolerated in the SAD study. 6. All adverse events reported in subjects receiving 191 were mild in severity, short-lived, and resolved spontaneously without intervention. No discontinuations due to AEs. All AEs classified as mild (CTCAE Grade 1). 7. No serious adverse events were reported in the SAD study. No clinically significant laboratory abnormalities or electro-cardiogram changes were reported 8. Most common AEs mild diarrhea and abdominal pain predominately in highest dose group. All mild and all resolving spontaneously, appeared to be attenuated in presence of food. 9. Have not seen anything that is cause for concern (RE Safety/tolerability) • Phase 1B Trial Information 1. 9/4/07 Announced approval of amended CTA in Europe, expect to initiate in 9/07. Initial top-line data expected in Q1 2008 2. September 26th began dosing patients. Approximately 40 HCV patients. 3. We plan to administer 191 for a period of 14 days to three ascending dose cohorts of treatment naïve chronic hepatitis C patients infected with HCV genotype 1. Twice per day and three times per day dosing regimens will be studied. And the study may be expended to additional cohorts of treatment naive patients based on results from the first three planned cohorts. In addition, a single cohort of non-responder patients is planned. 4. Will be dosing with food. We have said repeatedly that the food effect was not something we expected to see. And I think it is fair to say, again, we didn't expect it, because we hadn't seen it in animal models. And I think it is fair to say that that was one of the most important observations in terms of thinking about the changes. 5. We really don't want to find ourselves in a situation where we're in the middle, or partially through Phase II and have to go back and sort of approach exploring different doses or differing dosage intervals. And that has happened in some instances with other therapeutic ongoing in HCV. I would just throw that out as one example of we would like to go into Phase II pretty sure that we are encompassing the range of doses and dose schedules that we want to look at. 6. On dosing changes in amendment - we didn't discuss specifically what doses we were looking at previously... will just say that for the reasons that we have talked about we did move lower. 7. Three dose cohorts of treatment naïve and one of treatment experienced planned with the possibility of additional cohorts. BID and TID dosing regimens to be studied. 8. Expect to announce initial top-line viral kinetic and safety in Q1 2008 9. Don’t anticipate being in the range that those mild symptoms will be problematic in the MAD study, again very mild highest dose. Doses at mild symptoms observed were at many fold higher than those being studied in 1B. 10. Nothing unusual about study design (at least re in terms of placebo group size 2-3)
Other Pipeline/Interests • Equity interest in Targanta Therapeutics, http://www.targanta.com/ as a result of selling Oritavancin in December 2005. (http://tinyurl.com/yznhod). Now public company trading under symbol TARG. • Early stage work on PEGylated version of Actimmune (with Maxygen), does not appear to have much effort as this time. (http://tinyurl.com/yn4e4z) • PEG-Alfacon (PEGylated version of Infergen) appears unlikely to be further developed. • Research work in both Hepatology and Pulmonology o NiKem Research Srl collaboration in pulmonology (6/25/07 Nikem PR http://www.nikemresearch.com/news.htm) o deCODE Biostructures collaboration (5/25/2007 deCODE Biostructures PR http://www.decodechembio.com/news_archives.php?year=2007 ) o Second generation PI’s (Roche Collaboration). Roche would have right of first refusal with terms comparable to 191 (up-front to be negotiated) if they decline InterMune can pursue other partnerships for candidate. o Second target in Hepatology (undisclosed indication) Array collaboration. Royalty described by Array as high single digits. Array Responsible for creating clinical trial and all synthetic process. InterMune take into clinical development through commercialization. Partnership is described as met objectives and has been concluded.
Financials • Cash/securities 264 million (end of Q3 2007) • 170 million convertible. Coupon rate .25%. 2011 maturity. Conversion Price $21.63. • 39 million shares outstanding (after 9/07 offering) • 2007 Guidance o Revenue (was 70– 90 million, removed with March INSPIRE study being stopped for futility) o COGS (was 21-23%, removed with March INSPIRE study being stopped for futility) o R&D 100-110 million. Including 5-10 million for est. FAS 123R. o SG&A 25-35 million including 5-10 million for FAS 123R, excludes INSPIRE discontinuation expenses and possible contract wind-down costs (for Actimmune). • Government settlement for past Actimmune promotion (http://tinyurl.com/y3wa8a) . The company will pay $36.9 million plus 5% interest over five years. The first annual installment of $5 million paid in 2006. Note some acceleration terms exist should InterMune receive 150 million in partnering/licensing (capped at $10 million/year). • 10b5-1 plan entered into 9/07 http://tinyurl.com/2pok5z
Time-Line/Medical Presentations • Q1 ’08 191 Phase 1B data expected (for at least 1st 3 dose cohorts) • December’08/January ‘09 Top line results from CAPACITY
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