Newron Pharmaceuticals S.p.A. · SIX:NWRN
Newron Pharmaceuticals — Swiss Biotech Day 2021
17 slides from Newron Pharmaceuticals's conference presentation, Sep 7, 2021
Slide 1: The Specialist in CNS Drug Development - Innovative Treatments to Improve Quality of Life
THE SPECIALIST IN CNS DRUG DEVELOPMENT - INNOVATIVE TREATMENTS TO IMPROVE QUALITY OF LIFE Stefan Weber, CEO Swiss Biotech Day Basel, September 7, 2021
Slide 2: Disclaimer
Disclaimer RESTRICTED SCOPE; EXCLUSION OF LIABILITY; CONFIDENTIALITY This document has been prepared by Newron Pharmaceuticals S.p.A. ("Newron") solely for your information. The information contained herein has not been independently verified. No representation or warranty, express or implied, is ma
Slide 3: Company Highlights
Company Highlights Unique portfolio of innovative CNS product candidates • Xadago® for Parkinson’s disease – Global approvals validate Newron’s development capabilities from research to market • Evenamide – New concept in treating inadequate/non-response in schizophrenia • Ongoing search for strateg
Slide 4: Developing Uniquely Differentiated Drugs for CNS Targets
DEVELOPING UNIQUELY DIFFERENTIATED DRUGS FOR CNS TARGETS Xadago® (safinamide) Evenamide (NW-3509) Commercialized by partners in 15 European markets, the US, Phase IIa trial demonstrated efficacy; potential first mechanistically Canada and other markets for Parkinson’s disease (“PD”) validated treatm
Slide 5: Innovative Clinical Pipeline with Near-Term Catalysts
Innovative Clinical Pipeline with Near-Term Catalysts PRODUCTS Phase I Phase II Phase III Market Commercial Rights Adjunctive therapy in PD Zambon Adjunctive therapy in PD Zambon/Supernus Xadago® (safinamide)1 Adjunctive therapy in PD Meiji Seika/Eisai Levodopa Induced Dyskinesia (PD LID) Zambon/Sup
Slide 6: Xadago: 1st New Chemical Entity Approved in a Decade for Parkinson's Disease
Xadago®: 1st New Chemical Entity Approved in a Decade for Parkinson's Disease Fast and sustained efficacy, well tolerated Parkinson’s disease affects 7 to 10 million MID- TO LATE-STAGE PD PATIENTS – worldwide add-on to L-Dopa dopamine replacement Significant improvement of A progressive disorder,
Slide 7: Xadago: New Label Study in Patients with Levodopa Induced Dyskinesia
Xadago®: New Label Study in Patients with Levodopa Induced Dyskinesia • Zambon previously discussed with the US Food and Drug Administration (FDA) the design of a potentially pivotal efficacy study to evaluate the effects of Xadago®/safinamide in patients with PD LID • Intention is to perform the st
Slide 8: Significant Commercial Opportunity in Xadago (Safinamide)
Significant Commercial Opportunity in Xadago® (Safinamide) US / Canada EU Latin America Israel Japan / Asia Australia /New Zealand Launched in Germany, UK, Italy, Spain and other EU Launched in US in 2017 territories, Switzerland, UAE, Brazil and Colombia; Launched in Canada in 2019 Launched in Aust
Slide 9: Schizophrenia: No Effective Treatment for the Last 20 Years
Schizophrenia: No Effective Treatment for the Last 20 Years to Reduce Burden of Disease Efficacy of current treatment options is insufficient VAST MARKET Onset of disease occurs in early adulthood affecting 1% of the population worldwide OPPORTUNITY (anti-psychotics Most patients with schizophreni
Slide 10: Evenamide Novel MoA: Synergistic with Marketed Antipsychotics
Evenamide Novel MoA: Synergistic with Marketed Antipsychotics Evenamide, a Voltage-Gated Sodium Channels (VGSC) Voltage-Gated Sodium Channels (VGSC) blockers may act blocker has the potential to target the abnormal synergistically with antipsychotics in schizophrenia therapy neuronal activity and
Slide 11: Evenamide's Unique MOA Demonstrated
Evenamide’s Unique MOA Demonstrated Selectively blocks native sodium channels, showing no off-target effect on >130 CNS receptors, enzymes, transporters, etc. Modulates sustained repetitive firing Selectively blocks VGSCs in a Inhibits without inducing impairment of voltage-and use-dependent manner
Slide 12: Evenamide is Active in a Wide Range of Schizophrenia and Psychiatric Animal Models
Evenamide is Active in a Wide Range of Schizophrenia and Psychiatric Animal Models as a Monotherapy and as an Add-on to Existing Antipsychotics Monotherapy Add-on Pre-pulse inhibition (PPI) disrupted by dopamine activation (amphetamine -rat) Pre-pulse inhibition (PPI) disrupted by NMDA antag
Slide 13: Evenamide: Proof of Concept in Patients with Schizophrenia Demonstrated
Evenamide: Proof of Concept in Patients with Schizophrenia Demonstrated 4-week, placebo-controlled, add-on study of evenamide (15-25mg BID/day) in 89 patients on stable doses of aripiprazole or risperidone showing signs of worsening when compared to standard of care, at every assessment during the
Slide 14: Evenamide: Regulatory Interactions and Phase III Clinical Development Plan
Evenamide: Regulatory Interactions and Phase III Clinical Development Plan Health Authorities (Spain, Denmark, Sweden, Germany, UK, CHMP, US, Canada) in agreement with proposed Phase III plan Newron completed additional informative studies as requested by the FDA prior to allowing Newron to initiate
Slide 15: Evenamide: Regulatory Interactions and Phase III Clinical Development Plan
Evenamide: Regulatory Interactions and Phase III Clinical Development Plan • Phase II/III safety and efficacy study 008A • Four-week, randomized, double-blind placebo-controlled study • To evaluate safety (tolerability and EEG effects) and preliminary efficacy of 30 mg BID • Outpatients suffering fr
Slide 16: Company Highlights
Company Highlights Unique portfolio of innovative CNS product candidates • Xadago® for Parkinson’s disease – Global approvals validate Newron’s development capabilities from research to market • Evenamide – New concept in treating inadequate/non-response in schizophrenia • Ongoing search for strateg
Slide 17: Contact Details
CONTACT DETAILS NEWRON STEFAN WEBER – CEO +39 02 6103 46 26 pr@newron.com UK/EUROPE JULIA PHILLIPS / NATALIE GARLAND-COLLINS, FTI CONSULTING +44 20 3727 1000 SCnewron@fticonsulting.com SWITZERLAND VALENTIN HANDSCHIN +41 43 244 81 54 handschin@irf-reputation.ch GERMANY/EUROPE ANNE HENNECKE/CAROLINE B