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
›Three Rivers Pharmaceuticals Obtains Additional Commercial Rights to Infergen from Amgen
Wednesday September 17, 3:00 am ET
CRANBERRY TOWNSHIP, Pennsylvania, September 17 /PRNewswire/ -- Three Rivers Pharmaceuticals, LLC announced today that it has signed a definitive license agreement with Amgen Inc. to expand its commercial rights to the hepatitis C drug Infergen. Three Rivers Pharmaceuticals will obtain commercial rights to Infergen in all markets except Japan. In addition, Three Rivers Pharmaceuticals will obtain commercial rights to China effective March 31, 2009. Three Rivers Pharmaceuticals currently has commercial rights to Infergen in the United States and Canada.
"The expansion of commercial rights to Infergen compliments Three Rivers Pharmaceuticals strategy to continue to grow its hepatitis C franchise," stated Patrick Kerrish RPh., MBA Three Rivers Pharmaceuticals' Executive Vice President of Business Development.
Three Rivers Pharmaceuticals will seek marketing partners to assist with the commercialization of Infergen outside of the United States. Interested marketing partners should contact Patrick Kerrish at pkerrish@3riverspharma.com .
Infergen, or consensus interferon, is a unique, bio-optimized, selective and highly potent type 1 interferon alpha originally developed by Amgen and launched in the United States in 1997. Infergen is indicated for the treatment of chronic HCV infection in patients 18 years of age or older with compensated liver disease who have anti-HCV serum antibodies and /or the presence of HCV RNA.
About Three Rivers Pharmaceuticals
Three Rivers Pharmaceuticals is a privately held company headquartered in Cranberry Township, Pennsylvania that focuses on specialized therapies including hepatitis C therapies. With its unique experience and understanding of the complex challenges of treating chronic, difficult diseases, Three Rivers is a valuable partner in the healthcare community. The company's mission is to develop, manufacture, and market the highest quality branded and generic drug products for patients with serious diseases. Three Rivers Pharmaceuticals focuses on the specialized therapies because of its extensive knowledge and experience in this area. More information about the company can be found at www.3riverspharma.com‹
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