Amneal Pharmaceuticals, Inc. · NASDAQ:AMRX
Amneal Pharmaceuticals — Technical Presentation (August 2021)
21 slides from Amneal Pharmaceuticals's technical presentation, Aug 25, 2021
Slide 1: IPX-203 for Parkinson's Disease
IPX-203 for Parkinson’s Disease August 25, 2021 1 IPX-203 IS AN INVESTIGATIONAL PRODUCT THAT IS NOT APPROVED BY THE FDA.
Slide 2: Safe Harbor Statement
Safe Harbor Statement Certain statements contained in this presentation, regarding matters that are not historical facts, may be forward -looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding managem
Slide 3: Welcome and Opening Remarks
Welcome and Opening Remarks Chirag Patel Co-Chief Executive Officer Amneal Pharmaceuticals, Inc. Chintu Patel Co-Chief Executive Officer Amneal Pharmaceuticals, Inc.
Slide 4: Expanding Our Specialty Business Portfolio and Driving Growth
Expanding Our Specialty Business Portfolio and Driving Growth • Our Specialty strategy is to expand our Advancing our pipeline and accelerating transition to Specialty business through organic growth, advancing our pipeline, and pursuing 2022 2023 2024 2025 2026 accretive inorganic opportunities to
Slide 5: Unmet Needs Remain for Parkinson's Disease
Unmet Needs Remain for Parkinson’s Disease
Slide 6: Parkinson's Disease is the Fastest Growing Neurological Disorder Worldwide
Parkinson’s Disease is the Fastest Growing Neurological Disorder Worldwide with ~1 Million Patients Currently Diagnosed in the United States
Slide 7: There is a Need for Improved CD/LD Formulations to Help Patients Experience More Good On Time
There is a Need for Improved CD/LD Formulations to Help Patients Experience More “Good On” Time CURRENT TREATMENT OPTIONS IPX-203 was Developed to Potentially Help Patients • The combination of CD/LD has been the gold standard of Achieve More “Good On” Time with Less Frequent treatment for PD since
Slide 8: Advancing the Development of IPX-203 for Parkinson's Disease
Advancing the Development of IPX-203 for Parkinson’s Disease IPX-203 is a carbidopa-levodopa (CD/LD) treatment for patients with Parkinson’s disease and an investigational product not approved by FDA We are excited about the commercial opportunity that IPX-203 represents Developed with an innovative
Slide 9: Experts With Us Today
Experts With Us Today Richard D’Souza, PhD Robert A. Hauser, MD, MBA, FAAN Alberto J. Espay, MD, MSc, FAAN SVP, Specialty R&D, USF Health Neuroscience Institute University of Cincinnati Amneal Pharmaceuticals, Inc. Parkinson’s Disease and Movement Academic Health Center Disorders Center of Excellenc
Slide 10: RISE-PD Trial Overview
RISE-PD Trial Overview Richard D’Souza, PhD SVP, Specialty R&D Amneal Pharmaceuticals, Inc.
Slide 11: IPX-203 was Studied in a Pivotal Phase 3 Clinical Trial: RISE-PD
IPX-203 was Studied in a Pivotal Phase 3 Clinical Trial: RISE-PD • RISE-PD was designed to Screening IR CD/LD IPX-203 Double Blind Maintenance evaluate the efficacy and Dose Dose safety of IPX-203 in Adjustment Conversion 13 weeks IPX-203 comparison with immediate- Up to 3 weeks 4 weeks release CD/L
Slide 12: RISE-PD was Successful in Demonstrating Statistically Significant Improvement in Efficacy
RISE-PD was Successful in Demonstrating Statistically Significant Improvement in Efficacy for IPX-203 Compared With Immediate-Release CD/LD Primary Endpoint: • IPX-203 treatment resulted in 0.53 more hours of “Good On” time than immediate-release CD/LD (p=0.0194), when comparing change from baseline
Slide 13: RISE-PD Results
RISE-PD Results Robert A. Hauser, MD, MBA, FAAN USF Health Neuroscience Institute Alberto J. Espay, MD, MSc, FAAN University of Cincinnati Academic Health Center
Slide 14: IPX-203 Demonstrated a Statistically Significant Improvement in Good On Time
IPX-203 Demonstrated a Statistically Significant Improvement in “Good On” Time From Baseline to End of Study Baseline IR CD/LD IPX-203 IPX-203 or IR CD/LD Dose Adjustment Dose Conversion Double Blind Treatment on Stable / Optimized Dose 12.5 12 11.72 Mean “Good On” Time (Hours) 11.5 11.35 11.35 * 11
Slide 15: IPX-203 Demonstrated a Statistically Significant Reduction in Off Time
IPX-203 Demonstrated a Statistically Significant Reduction in “Off” Time From Baseline to End of Study Baseline IR CD/LD IPX-203 IPX-203 or IR CD/LD Dose Adjustment Dose Conversion Double Blind Treatment on Stable / Optimized Dose 6.5 6.15 6 6.05 5.46 Mean “Off” Time (Hours) Random ization 5.5 5.41
Slide 16: RISE-PD Secondary Endpoints
RISE-PD Secondary Endpoints Week 7 Week 20 Enrollment Baseline End of Study p-value (Randomization) (or Early Termination) Percent of patients reporting “much improved” or “very much improved” score on PGI-C scale IPX-203 N/A N/A 29.7% 0.0015 IR CD/LD N/A N/A 18.8% Mean MDS-UPDRS Part III score IPX-
Slide 17: Post Hoc Analysis: IPX-203 Provided 1.55 More Hours of Good On Time Per Dose
Post Hoc Analysis: IPX-203 Provided 1.55 More Hours of “Good On” Time Per Dose Compared With Immediate-Release CD/LD “Good On” time per dose at EOS (Week 20) IR CD/LD IPX-203 2.21 3.76 * 0 0.5 1 1.5 2 2.5 3 3.5 4 Hours *LS Mean difference = 1.55h, p<0.0001. EOS, end of study; IR CD/LD, immediate-rel
Slide 18: Most Common Adverse Events in RISE-PD
Most Common Adverse Events in RISE-PD Most Common Adverse Events Occurring in ≥3% of Patients IPX-203 IR CD/LD Dose conversion Maintenance Dose adjustment Maintenance (N=589) (N=256) (N=630) (N=250) Nausea 4.9% 4.3% 1.1% 0.8% Dry mouth 4.2% 1.2% 0.3% 0.8% Urinary tract infection 1.2% 1.6% 0.2% 3.2%
Slide 19: Summary and Next Steps
Summary and Next Steps • Phase 3 study successfully demonstrated a statistically significant improvement in efficacy of IPX-203 compared to immediate-release CD/LD, even when IPX-203 was dosed on average 3 times per day and immediate-release CD/LD was dosed on average 5 times per day • Based on thes
Slide 20: Q&A
Q&A Chirag Patel Stanley Fisher, MD Co-Chief Executive Officer VP, Medical Affairs Amneal Pharmaceuticals, Inc. Amneal Pharmaceuticals, Inc. Chintu Patel Robert A. Hauser, MD, MBA, FAAN Co-Chief Executive Officer USF Health Neuroscience Institute Amneal Pharmaceuticals, Inc. Alberto J. Espay, MD, MS
Slide 21: amneal
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