Regeneron Pharmaceuticals, Inc. · NASDAQ:REGN
Regeneron Pharmaceuticals — Shareholder Meeting (June 2006)
29 slides from Regeneron Pharmaceuticals's shareholder meeting presentation, Jun 9, 2006
Slide 1: Regeneron Pharmaceuticals, Inc. Annual Shareholders Meeting June 9, 2006
Regeneron Pharmaceuticals, Inc. Annual Shareholders Meeting June 9, 2006
Slide 2: Safe Harbor Statement
Safe Harbor Statement Except for historical information, the matters contained in this presentation may constitute forward-looking statements that involve risks and uncertainties, including uncertainties related to product development and clinical trials, unforeseen safety issues resulting from the
Slide 3: Regeneron Overview
Regeneron Overview 3 major clinical programs Oncology Eye Diseases Inflammatory Diseases Major collaboration with sanofi-aventis Opportunity for additional collaborations including eye program and VelocImmune(tm) Manufacturing expertise at 10,000 liter scale Next generation platform for monoclonal a
Slide 4: Recent Progress
Recent Progress Oncology Three phase 2 single agent trials Completing preparations for 3 Phase 3 combination studies FDA submission targeted for 2007/2008 timeframe Eye diseases Reported positive preliminary results in wet AMD Phase 2 study underway Phase 3 planned for initiation early 2007 Partneri
Slide 5: "Mechanism" vs. "Execution" Risk
"Mechanism" vs. "Execution" Risk Mechanism Risk Target not validated; no approved products with same molecular target Mechanism-based toxicity ill-defined Historically high rate of failure Execution Risk Approved product validates molecular target and safety profile Higher probability of successful
Slide 6: Regeneron Clinical Product Candidates
Regeneron Clinical Product Candidates Each candidate designed to address clinically validated target Each has opportunity to expand to new disease settings Clinical evidence already obtained indicating that each candidate addresses its target Regulatory approval strategy defined for each candidate E
Slide 7: VEGF Trap Oncology: The sanofi-aventis Collaboration
VEGF Trap Oncology The sanofi-aventis Collaboration Favorable financial opportunity for Regeneron sanofi-aventis funds global development Repayment of 50% out of profits according to formula $400 MM in commercial approval milestones 50:50 global profit split (35% royalty in Japan) Co-promotion right
Slide 8: Blocking VEGF with VEGF Trap
Blocking VEGF with VEGF Trap Clinical evidence that VEGF Trap can address "VEGF target" Blood samples demonstrate "trapping" of VEGF Decreased perfusion/vascular permeability after single dose Adverse events of hypertension and proteinuria; expected based on Avastin(r) results Responses observed in
Slide 9: Targeting the VEGF Pathway
Targeting the VEGF Pathway VEGF Y Anti-VEGFR-2 Anti-VEGFR-1 Y Anti-VEGF (Avastin(r), Lucentis(tm)) VEGF Receptor Aptamer (Macugen(r)) Kinase Inhibitors VEGF Trap SiRNA
Slide 10: Comparison of VEGF Trap and Avastin
Comparison of VEGF Trap and Avastin(r) IC50 for VEGF Trap = 44pM IC50 for Avastin = 1400pM VEGF Trap has markedly higher affinity for VEGF than Avastin based on in vitro bioassay
Slide 11: Single Agent Studies in Late-stage Cancer Patients
VEGF Trap Oncology Non-small Cell Lung Adenocarcinoma (NSCLA) Approximately 100 patients Single arm, open label design Primary endpoint objective response rate Ovarian Cancer Approximately 200 patients Randomized comparison of 2 doses of VEGF Trap Primary endpoint objective response rate Symptomatic
Slide 12: Preliminary Anti-tumor Activity: Ovarian Cancer Patient
Prior Treatments: Carboplatinum + Paclitaxel; Carboplatinum + Gemcitabine Preliminary Anti-tumor Activity Ovarian Cancer Patient VEGF Trap 4.0 mg/kg IV biweekly x 4 Diagnosis: Recurrent Advanced Ovarian Epithelial Adenocarcinoma
Slide 13: Symptomatic Malignant Ascites: Complete Resolution after 4 Doses
Baseline Week 8 Prior Treatments: Carboplatinum + Paclitaxel; Carboplatinum + Gemcitabine VEGF Trap 4.0 mg/kg IV biweekly x 4 Symptomatic Malignant Ascites Complete Resolution after 4 Doses of VEGF Trap
Slide 14: VEGF Trap Studies in Combination with Standard Chemotherapy Regimens
VEGF Trap Oncology 5 phase 1b studies in different chemotherapy regimens Encouraging early data with responses observed in heavily pretreated patients Phase 3 program to begin 2H 2006 VEGF Trap Studies in Combination with Standard Chemotherapy Regimens
Slide 15: VEGF Trap Studies Planned with National Cancer Institute
VEGF Trap Oncology National Cancer Institute to conduct trials of VEGF Trap under Clinical Trials Agreement between CTEP, NCI, and sanofi-aventis 10-12 efficacy/safety studies planned for 2006 VEGF Trap Studies being planned with National Cancer Institute
Slide 16: VEGF Trap Oncology Summary
VEGF Trap Oncology Summary VEGF confirmed as validated target Preliminary clinical evidence already obtained that VEGF Trap addresses target Clinical program being rapidly expanded Sanofi-aventis primary responsibility for execution of clinical trials First submission for approval planned for 2007/2
Slide 17: VEGF Trap Eye Program
VEGF Trap Eye Program 100% owned by Regeneron Partnering opportunity Initial target is neovascular form of age- related macular degeneration (wet AMD) Diabetic macular edema and diabetic proliferative retinopathy are additional commercial opportunities
Slide 18: Wet AMD: Opportunity
Wet AMD: Opportunity Ability to give higher doses of more potent agent create opportunity for VEGF Trap-Eye program Goal is to prove that VEGF Trap is "best in class" by demonstrating in clinical trials: More convenient dosing interval Greater improvement of vision at optimal dosing interval
Slide 19: Phase 1 Intravitreal Trial
Phase 1 Intravitreal Trial Dose-ascending cohorts of 3-6 subjects given single intravitreal injection to determine maximum tolerated dose Primary endpoint safety and tolerability Ocular coherence tomography (OCT) to assess retinal thickness Status and preliminary results Dose levels of 0.05, 0.15, 0
Slide 20: Intravitreal VEGF Trap-Eye 1.0 mg Single Dose
Intravitreal VEGF Trap - Eye 1.0 mg Single Dose 1.0 mg Single Dose 1.0 mg Single Dose Baseline: 732µ Baseline: 732µ Week 2: 168µ Week 8: 182µ Week 1: 196µ
Slide 21: Median Excess Retinal Thickness at Baseline and Week 6
Fast Map Posterior Pole Baseline 119 194 Week 6 27 60 Median Excess Retinal Thickness at Baseline and Week 6 * * p < .05, Wilcoxon *
Slide 22: Change in Visual Acuity in Highest Dose Groups
Change in Visual Acuity in 2 Highest Dose Groups Following Single Intravitreal Injection 0 1 2 4 6 Three of 6 treated patients in two highest dose groups had >3-line gain in vision at day 43
Slide 23: VEGF Trap-Eye Summary
VEGF Trap - Eye Summary Confirmed evidence of biological activity Rapid, substantial, and prolonged reduction in retinal thickness Preliminary evidence for improved visual outcome Positioned for rapid expansion of program Phase 2 wet AMD trial underway DME pilot study underway Potential partnering o
Slide 24: The IL-1 Trap Development Program
Registration study initiated in rare genetic diseases 4Q 2005 Proof-of-concept trial initiated in Systemic Onset Juvenile Idiopathic Arthritis (SJIA) 4Q 2005 The IL-1 Trap Development Program
Slide 25: IL-1 Trap CAPS POC Study
IL-1 Trap CAPS POC Study (5 patients) IL-1 Trap rapidly and dramatically: Improves subjective measures of disease Lowers blood markers of inflammation (e.g., CRP, SAA, ESR) "Traps" IL-1 and convincingly confirms markedly increased IL-1 levels in this disease No significant safety concerns noted in s
Slide 26: IL-1 Trap CAPS Registration Study
IL-1 Trap CAPS Registration Study Orphan drug and Fast Track designations 160 mg/week dose Study phases include 6 month placebo controlled, double blind (efficacy/safety) 6 month label extension (safety) Patient enrollment completed Top-line efficacy data available 2H 2006 BLA submission planned for
Slide 27: VelocImmune: Proprietary New Approach for Human Monoclonal Antibodies
VelocImmune: Proprietary New Approach for Therapeutic Human Monoclonal Antibodies Produces wide variety of high affinity human antibodies against target Synergizes with commercial-scale manufacturing and proprietary approach to cell line development Applicable to both validated and novel targets Ove
Slide 28: Regeneron's Major Development Programs: Mid 2007 Future Plans
Regeneron's major development programs mid 2007: future plans Oncology 3 single agent efficacy studies well underway 3 large studies in combination with chemotherapy underway About 12 studies underway in collaboration with NCI CTEP program Eye Phase 2 trial completed and data reported Phase 3 trial
Slide 29: Regeneron Pharmaceuticals, Inc. Annual Shareholders Meeting June 9, 2006
Regeneron Pharmaceuticals, Inc. Annual Shareholders Meeting June 9, 2006
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