Biotech Values

[ghmm]

Substantially Revamped

InterMune http://www.intermune.com/
i-hub InterMune board: http://investorshub.advfn.com/boards/board.asp?board_id=8637


Call Summaries
Q1 2007 #msg-19408521
Q2 2007 #msg-23131457
Q3 2007 #msg-24264853
JP Morgan 26th Annual Healthcare Conference Notes #msg-25836765
Wachovia 2008 Healthcare Conference #msg-26491473
Q4 2007 #msg-26701562


Historic Jobs List #msg-26491523

Commentary on InterMune buyout of the future Pirfenidone License Obligation to Marnac #msg-24817787
Some other studies on Pirfenidone #msg-24788957
IPF/Pulmonary Fibrosis Competitive Landscape #msg-26702328


Pirfenidone Program
• IP Expansion and life-cycle management efforts underway since 2005
• Comments on Buyout of Royalty from Marnac #msg-24817787

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 (R7227)

• 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. September 26th began dosing patients. Approximately 40 HCV patients.
2. Triple combination study expected to start in Q2 2008
3. January 7th 2008 announced completed first 2 dose cohorts of up to 300mg DAILY doses. Additional commentary and information on 1/7/08 Phase 1B update PR #msg-25802407


Misc. / Early Stage Programs
• 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. 3million shares, 600,300 available for sale.
• 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 ITMN-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 235.3 million (end of Q4 2007)
• 170 million convertible. Coupon rate .25%. 2011 maturity. Conversion Price $21.63.
• 39 million shares outstanding
• 2008 Guidance
o R&D 100-110 million, net of Roche reimbursement (they pay 2/3 of all PI development costs).
o G&A 25-30 million

Time-Line/Medical Presentations
• EASL and/or DDW All available Data on 4 cohorts of Phase 1B ITMN-191 (R7227). May also PR on or before meetings.
• After 4th cohort of treatment naïve patients in Phase 1B MAD study will have a single cohort of treatment-experienced patients
• Q2 2008 Initiate triple combinations study of ITMN-191 (R7227) in EU (14 day with Pegasus and ribavirin)
• 2nd Half 2008 Roche to file IND for ITMN-191 (R7227) in US
• January ‘09 Top line results from CAPACITY Trials