Insmed Incorporated · NASDAQ:INSM
Insmed — Corporate Update (January 2018)
21 slides from Insmed's corporate update, Jan 3, 2018
Slide 1: Safe Harbor Statement
Safe Harbor Statement 2 This presentation contains forward looking statements. "Forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein suc
Slide 2: Agenda
3 Agenda Review interim positive data from Phase 3 INS-212 and INS-312 studies Regulatory and pre-commercial update 2018 Priorities
Slide 3: Treatment of NTM Lung Disease Represents A Significant Unmet Need
Treatment of NTM Lung Disease Represents A Significant Unmet Need Current antibiotic regimens are inadequate in treating NTM disease, with no known approved therapies in US and EU 4 1 2 3 4 5 Globally prevalent and growing at approximately 8% annually in the US Up to 33% mortality rate for patients
Slide 4: ALIS once daily + Guideline Based Therapy: Adult Patients with NTM (MAC) Lung Disease
ALIS once daily + Guideline Based Therapy 5 Adult Patients with NTM (MAC) Lung Disease Failing at least 6 months of a multi-drug regimen KEY INCLUSION CRITERIA Guideline Based Therapy R Screening period Month-6 sputum culture PRIMARY ENDPOINT Culture Conversion at 6 months INS-212 non-converters INS
Slide 5: Top-line Data Indicates INS-212 Study Met Primary Endpoint
Top-line Data Indicates INS-212 Study Met Primary Endpoint 6 Percentage of Patients with Sputum Culture CONVERSION (3 Consecutive Negative Sputum Cultures) GBT = Guideline Based Therapy Study was 90% powered to show a 15% difference between the treatment arms, assuming that 20% on ALIS + GBT would c
Slide 6: ALIS once daily + Guideline Based Therapy: Adult Patients with NTM (MAC) Lung Disease
ALIS once daily + Guideline Based Therapy 7 Adult Patients with NTM (MAC) Lung Disease Failing at least 6 months of a multi-drug regimen KEY INCLUSION CRITERIA Guideline Based Therapy R Screening period Month-6 sputum culture PRIMARY ENDPOINT Culture Conversion at 6 months INS-212 non-converters 90
Slide 7: Today's Interim Data Provide Early Answers to Three Key Questions
8 Today’s Interim Data Provide Early Answers to Three Key Questions Are the interim results from INS-312 consistent with what we observed in top line results from INS-212? Do additional patients achieve culture conversion with continued treatment with ALIS beyond six months? Are the effects of ALIS
Slide 8: Question 1: Are the interim results from INS-312 consistent with INS-212?
9 Question 1 Are the interim results from INS-312 consistent with what we observed in top line results from INS-212?
Slide 9: Question 1: Interim Data Show Culture Conversion in INS-312 Consistent with INS-212
Question 1: Interim Descriptive Data Show that Sputum Culture Conversion in INS-312 is Consistent with Sputum Culture Conversion in Top Line Results from INS-212 10 Percentage of Patients with Sputum Culture CONVERSION AS OF DECEMBER 2017* (3 Consecutive Negative Sputum Cultures) 29% of patients ini
Slide 10: Question 2: Additional patients achieving culture conversion beyond six months
11 Question 2 Do additional patients achieve culture conversion with continued treatment with ALIS beyond six months?
Slide 11: Question 2: Continued Treatment with ALIS + GBT Results in More Patients Achieving Culture Conversion
12 29% (65/224) *As of December 2017, 57 of 73 patients in the prior ALIS + GBT Arm in INS-212 were evaluable for Sputum Culture Conversion 12% of prior non-converters from INS-212 ALIS + GBT arm achieved culture conversion by Month 6 in INS-312 Question 2: Interim Descriptive Data Show Continued Tr
Slide 12: Question 3: Are the effects of ALIS durable?
13 Question 3 Are the effects of ALIS durable? Durability is the percent of patients who complete the treatment cycle and remain culture negative 3 months off all therapy. Durability three months off all treatment is the endpoint required to support full approval.
Slide 13: Question 3: Durability of Culture Conversion Higher in ALIS + GBT Arm
Question 3: Interim Descriptive Data Show that in INS-212, Durability of Culture Conversion is Substantially Higher in ALIS + GBT Arm (61% vs. 0% as of December 2017)* 14 Percentage of Converters from each arm who remain culture negative three months off treatment ALIS + GBT shows a more durable cul
Slide 14: INS-212 and INS-312 Safety Summary
INS-212 and INS-312 Safety Summary No Change in Overall Safety Assessment for ALIS Based on Interim Data INS-212 Adverse events, consistent with those seen with use of inhaled antibiotics, more frequent in ALIS + GBT arm Serious treatment emergent adverse events were similar between treatment arms N
Slide 15: Global Opportunity – Near-Term Focus on US, Japan and EU
Global Opportunity – Near-Term Focus on US, Japan and EU 16 *Source: Internal analysis of published NTM epidemiology, primary market research with treating HCPs, and anonymized patient level claims data in US † EU5 comprised of France, Germany, Italy, Spain and the United Kingdom 125K – 145K total d
Slide 16: Progressing U.S. Regulatory and Pre-Commercial Efforts in Parallel
Progressing U.S. Regulatory and Pre-Commercial Efforts in Parallel 17 Regulatory Plan to file NDA before end of March Planning for FDA decision by year-end 2018 Commercial Expanding pre-commercial efforts in preparation of potential launch at approval
Slide 17: Advancing Efforts to Support Approval in Japan
Advancing Efforts to Support Approval in Japan Established Japanese Subsidiary Building initial infrastructure Requirement for regulatory approval Engagement with PMDA Confirmation of data package and filing strategy with PMDA Planned for 2018 Submit Filing Translate filing into Japanese Pursue orph
Slide 18: Growing Pipeline
PRECLINICAL PHASE 1 PHASE 2 PHASE 3 ARIKAYCE®: Amikacin Liposome Inhalation Suspension (ALIS) Refractory NTM: M. avium Complex (MAC) ARIKAYCE®: Amikacin Liposome Inhalation Suspension (ALIS) Front line, maintenance, other non MAC NTM species, e.g. M. abscessus INS1007: DPP1 Inhibitor Non-CF bronchie
Slide 19: 2018 Priorities
2018 Priorities 20 PREPARE FOR U.S. LAUNCH GEOGRAPHIC EXPANSION INVESTMENT IN PIPELINE INVEST IN MANUFACTURING CAPACITY
Slide 20: 2018 Priorities
2018 Priorities Insmed *
Slide 21: Insmed