In response to a question, Dan Welch said ritonavir boosting of ITMN-191 was not out of the question, but he couldn’t comment on it because such disclosures fall within Roche’s purview.
Welch’s comment contrasts with VRTX’s assertion on its EASL webcast that ritonavir has no value whatsoever in boosting Telaprevir.
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
Financials 175.2 Million (End of Q1 ‘09) ~138 Debt (2 convertibles 53 million due March ’11 convert price $21.63 other 85 million due March ’15 convert price $18.88) ~49.6 million shares outstanding (not counting converts – ~6.3 million shares and options 4.6 million) As of 3/31/09
Upcoming Events May 19, 2009: ATS Presentation of CAPACITY Results (company will have webcast as well) Summer ’09: US NDA submission for Pirfenidone Summer ’09: Roche to initiate Phase 2B study with ITMN-191 (R7227) End ’09: EMEA MAA submission for Pirfenidone Q4 2009 (AASLD): Presentation of all cohorts of INFORM-1 Q4 ‘09/Q1 ’10: RVR data from 12 week cohort of Phase 2B R7227 study Mid ’10: File IND for ITMN-520 (Pirfenidone Analog)
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