Newron Pharmaceuticals S.p.A. · SIX:NWRN
Newron Pharmaceuticals — Swiss Equities Conference 2022
19 slides from Newron Pharmaceuticals's conference presentation, Jan 14, 2022
Slide 1: Specialist in CNS Drug Development
SPECIALIST IN CNS DRUG DEVELOPMENT INNOVATIVE TREATMENTS TO IMPROVE QUALITY OF LIFE Swiss Equities Conference 2022 January 14, 2022
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 in PD: Marketed compound with opportunity for second label
• FIRST APPROVED NCE IN >10 YRS (US, EU) • GLOBALLY LICENSED Xadago in PD • DOUBLE DIGIT/SINGLE DIGIT % ROYALTIES Marketed >€60M MILESTONES/ROYALTIES COLLECTED • TO REACH PEAK COMMERCIAL POTENTIAL, compound with GET SECOND LABEL FOR LID IN PD opportunity for • 40% OF PD PATIENTS • ONLY 1 APPROVED DR
Slide 7: 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 8: 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 9: 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 10: What Differentiates Evenamide in Schizophrenia
• LARGE MARKET • UNIQUE MOA AND POSITIONING • First anti-psychotic add-on drug • Change a non-responder into a responder What • No need to change current therapy, differentiates minimizing risk of patient relapse • Ease-of-use for patients & physicians Evenamide • First TRS add-on drug Opportunity t
Slide 11: Schizophrenia: 20 Million Patients Worldwide Without Effective Drug
SCHIZOPHRENIA: 20 MILLION PATIENTS WORLDWIDE (1% PREVALENCE) WITHOUT EFFECTIVE DRUG TO ELIMINATE SYMPTOMS, REDUCE PROGRESSION, LIMIT DISABILITY, SUICIDE OR EARLY MORTALITY Over 30 antipsychotics available, but all provide short-term and insufficient relief of some of the symptoms, only VAST MARKET P
Slide 12: Evenamide – The Commercial Opportunity
EVENAMIDE – THE COMMERCIAL OPPORTUNITY Addresses medical need in key sub-populations, COM: 2033 (WW), 10 yrs exclusivity post approval (EU, China) First add-on antipsychotic to be approved for inadequately responding or treatment resistant patients − Up to 70% of schizophrenia population every (on
Slide 13: 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 14: Evenamide Is Active in a Wide Range of Schizophrenia 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 15: 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 16: Evenamide: Regulatory Interactions
EVENAMIDE: REGULATORY INTERACTIONS 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 its Phase III development program - Pre
Slide 17: Evenamide: Phase III Clinical Development Plan for Schizophrenia Indication
EVENAMIDE: PHASE III CLINICAL DEVELOPMENT PLAN FOR SCHIZOPHRENIA INDICATION Phase III program will cover specific populations: • Non-treatment resistant patients: chronic schizophrenics experiencing inadequate benefit for symptoms of their psychosis, on current atypical antipsychotic monotherapy (ri
Slide 18: 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 19: 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
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