Replies to post #74782 on Biotech Values

[mcbio]

How will ITMN-191 differentiate itself among PIs?

Ghmm, you may best be able to answer this as I know you have the RMF for ITMN. I'm just curious what the consensus is on how ITMN-191 will be able to differentiate itself from the other HCV PIs. The compound clearly won't be first-in-class, barring a setback from telaprevir or boceprevir in Phase III. Also, I don't know if the compound will be a best-in-class either as I assume it's more of a first generation PI. The second generation PIs expect to improve upon the first with greater potency, which would allow co-formulation down the road, and presumably a greater safety margin.

What are your thoughts on this? Do you believe ITMN-191 already incorporates attributes of the second generation PIs? Or are you more or less counting on the fact that ITMN-191 is ahead of those second generation PIs in the clinic and should therefore have some time on the market to itself along with the other first generation PIs?

[ghmm]

InterMune ReadMeFirst

Edits: INFORM Info, EASL Abstracts

Call Summaries
#msg-19408521 Q1 2007
#msg-23131457 Q2 2007
#msg-24264853 Q3 2007
#msg-25836765 JP Morgan 26th Annual Healthcare Conference Notes
#msg-26491473 Wachovia 2008 Healthcare Conference
#msg-26701562 Q4 2007
#msg-29981789 Needham / Goldman Sachs 6/2008
#msg-31934416 Thomas Weisel Partners 9/4/08
#msg-33658397 LCM 11/08
#msg-34751687 191 Phase 1B triple combo results
#msg-34858414 JP Morgan 1/15/09
#msg-35347863 2/3/09 CAPACITY Trial Results Call/Presentation notes and Speculations
#msg-35922220 2/26/09 Q4 2008 Call/PR Notes
#msg-36393012 3/17/09 Cowen Health Care Conference Notes
#msg-37312942 4/25/09 EASL INFORM-1

OLD RMF
#msg-33516864
#msg-26702355

HCV
http://clinicaltrials.gov/ct2/show/NCT00801255 - INFORM Clinical Trials.gov
#msg-37309589 4/25/09 PR Combination of R7227, protease inhibitor, and R7128, nucleoside polymerase inhibitor, shows significant potency in reducing viral load in patients with hepatitis C
#msg-37306972 4/24/09 PR InterMune Reports Presentation of Triple Combination Study of ITMN-191 at European Association for the Study of the Liver (EASL)
#msg-37208214 4/21/09 PR INFORM-1 Clinical Trial Amended to Further Explore Promising Direct Antiviral Regimen in HCV Patients
#msg-36388140 (EASL Abstract) FIRST-IN-MAN DEMONSTRATION OF POTENT ANTIVIRAL ACTIVITY WITH A NUCLEOSIDE POLYMERASE (R7128) AND PROTEASE (R7227/ITMN-191) INHIBITOR COMBINATION IN HCV: SAFETY, PHARMACOKINETICS, AND VIROLOGIC RESULTS FROM INFORM-1
#msg-36421384 (EASL Abstract) COMBINATION OF THE NS3/4A PROTEASE INHIBITOR ITMN-191 WITH THE ALLOSTERIC NS5B POLYMERASE INHIBITOR ITMN-8020 ENHANCES REPLICON CLEARANCE AND REDUCES THE EMERGENCE OF DRUG RESISTANT VARIANTS
#msg-36421330 (EASL Abstract) SUPPRESSION OF IN VITRO RESISTANCE DEVELOPMENT AFTER TREATMENT OF THE HCV REPLICON WITH NS3/4A INHIBITOR ITMN-191 (R7227) IN COMBINATION WITH NUCLEOSIDE INHIBITOR R7128 OR R1626
#msg-36421289 (EASL Abstract) INCIDENCE OF VIROLOGIC ESCAPE OBSERVED DURING ITMN-191 (R7227) MONOTHERAPY IS GENOTYPE DEPENDENT, ASSOCIATED WITH A SPECIFIC NS3 SUBSTITUTION, AND SUPPRESSED UPON COMBINATION WITH PEGINTERFERON ALFA-2A/RIBAVIRIN
#msg-36421248 (EASL Abstract) INTERFERON-GAMMA, INTERFERON-ALPHA AND RIBAVIRIN IN COMBINED THERAPY OF CHRONIC HEPATITIS C PATIENTS
#msg-34747018 InterMune Reports Results from Triple Combination Study of ITMN-191
#msg-33270432 (AASLD Poster) HCV NS3 helicase inhibitor screening
#msg-33270394 (AASLD Poster) phenotypic analysis of NS3 sequences
#msg-33270382 (AASLD Poster) ITMN-191 (R7227) with the Active Moiety of the NS5B Inhibitors
#msg-33270355(AASLD Poster) PK-PD for ITMN-191 in a Phase 1 MAD
#msg-33270341 (AASLD Poster) ITMN-191 Phase 1b
#msg-33270294 (AASLD Poster) ITMN-191 Phase 1A
#msg-33270262 (AASLD Poster) ITMN-5489
#msg-33446127 INFORM-1 Trial Initiation
#msg-33497987 INFORM-1 Study information (from DB webcast), #msg-36349693 detail on cohorts.
#msg-33967428 INFORM-1 clinical trials.gov info
#msg-36388140 (EASL Abstract) INFORM-1, #msg-36393100 some commentary
#msg-36421384 (EASL Abstract) COMBINATION OF THE NS3/4A PROTEASE INHIBITOR ITMN-191 WITH THE ALLOSTERIC NS5B POLYMERASE INHIBITOR ITMN-8020 ENHANCES REPLICON CLEARANCE AND REDUCES THE EMERGENCE OF DRUG RESISTANT VARIANTS
#msg-36421330 (EASL Abstract) SUPPRESSION OF IN VITRO RESISTANCE DEVELOPMENT AFTER TREATMENT OF THE HCV REPLICON WITH NS3/4A INHIBITOR ITMN-191 (R7227) IN COMBINATION WITH NUCLEOSIDE INHIBITOR R7128 OR R1626
#msg-36421289 (EASL Abstract) INCIDENCE OF VIROLOGIC ESCAPE OBSERVED DURING ITMN-191 (R7227) MONOTHERAPY IS GENOTYPE DEPENDENT, ASSOCIATED WITH A SPECIFIC NS3 SUBSTITUTION, AND SUPPRESSED UPON COMBINATION WITH PEGINTERFERON ALFA-2A/RIBAVIRIN
#msg-36421248 (EASL Abstract) INTERFERON-GAMMA, INTERFERON-ALPHA AND RIBAVIRIN IN COMBINED THERAPY OF CHRONIC HEPATITIS C PATIENTS

IPF
#msg-35288566 CAPACITY Trial Results PR
#msg-34138706 Shionogi announced the launch of Pirespa (Pirfenidone)
#msg-33518800 Differences between Shionogi Phase 3 and CAPACITY (Pirfenidone Phase 3)
#msg-32898098 Shionogi received marketing approval

#msg-26702328 Competitive Landscape
#msg-32434359 Update on Actelion (Tracleer) enrollment/results timeline
#msg-30869320 Update on Actelion (Tracleer) some BUILD-3 details
#msg-33788471 JNJ
#msg-30792742 Gilead (Letairis)

Financials
154.7 Million (End of Q4) + 63.5 million 2/09 Financing
170 Debt (2 convertibles 85 million due March ’11 convert price $21.63 other 85 million due March ’15 convert price $18.88)
43.4 million shares outstanding (not counting converts – 8.432 million shares and options 4.6 million) As of 12/31/08

Upcoming Events
Q2 2009 (EASL): Present ITMN-191 Phase 1b triple combination study results
Q2 2009 (EASL): Present top-line results of available cohorts from INFORM-1
Q2 2009 (ATS): Present Pirfenidone results
Summer ’09: Roche to initiate Phase 2B study with ITMN-191 (R7227)
Summer ’09: Submit NDA to FDA for Pirfenidone
Q4 2009 (AASLD): Presentation of all cohorts of INFORM-1
End ’09: Submit NDA to MAA for Pirfenidone
Q4 ‘09/Q1 ’10: RVR data from 12 week cohort of Phase 2B R7227 study
Mid ’10: File IND for ITMN-520 (Pirfenidone Analog)


Company Website: http://www.intermune.com/wt/home
SEC Filings: http://tinyurl.com/8vdp2p
Most Recent 10-K: http://tinyurl.com/djxqq6