Laboratorios Farmaceuticos Rovi, S.a. · BME:ROVI
Laboratorios Farmaceuticos Rovi — Investor Presentation (2017)
46 slides from Laboratorios Farmaceuticos Rovi's investor presentation, 2017
Slide 1: DORIA®
DORIA® The fast onset of action long-acting injectable of risperidone Based on our ISM® patented technology
Slide 2: Disclaimer
Disclaimer This document has been prepared by Laboratorios Farmacéuticos Rovi, S.A. (“ROVI” or the “Company”), solely for its use during the attached presentation. The information and each of the opinions and statements contained in this document have not been verified by independent experts and, th
Slide 3: Index
Index Executive summary 1. Schizophrenia and antipsychotics A. Schizophrenia and antipsychotics B. Long Acting Injectables (LAIs) 2. ISM® technology 3. DORIA® A. Risperidone ISM®: DORIA® B. Drug development plan of DORIA® a) Conclusion of Phase I & II b) Prisma 3 study: Phase III c) Comparative bioa
Slide 4: Executive Summary
Executive Summary • ROVI is going through an important moment in its history launching our biosimilar of enoxaparin in Europe and beginning one Phase III and other Phase I in our R&D pipeline. • ROVI has begun a Phase III study for a long-acting injectable (LAI) based in the ISM® technology patented
Slide 5: Executive Summary: DORIA® Strategic Drivers
Executive Summary: DORIA® Strategic Drivers • DORIA® is a long acting injectable (LAI) based in the ISM® technology developed by ROVI. Proprietary Robust technology : technology for Predictable and solid long acting clinical outcome • LAI is becoming the goal standard for injectable Schizophrenia. •
Slide 6: Schizophrenia and antipsychotics
Schizophrenia and antipsychotics
Slide 7: Epidemiology of Schizophrenic Disorders
Epidemiology of Schizophrenic Disorders • Schizophrenia is a complex illness with no cure, although effective treatments are available to control symptoms and reduce disability. • In 2013, 1.7Mn schizophrenic disorders* were diagnosed in US and 1.6Mn were diagnosed in Top 5 Europe. • From 2013 to 20
Slide 8: Course of Schizophrenia: A progressive disorder
Course of Schizophrenia: A progressive disorder Gest-Child Puberty Adolescence Adult Middle Age Senescence Developmental stage IRREVERSIBLE DETERIORATION Relapse First episode Response 100 % Level of functioning (relative %) Positive symptoms; Negative symptoms; Cognitive symptoms; Mood symptoms Pos
Slide 9: Schizophrenia's phases
Schizophrenia’s phases ACUTE PHASE STABILIZATION PHASE STABLE PHASE Treatment goals* • Prevent harm and control disturbed • Reduce stress on the patient. • Sustain symptom remission or behavior. • Provide support to minimize the control. • Reduce psychosis and symptoms. likelihood of relapse. • Main
Slide 10: Frequency of acute exacerbations in schizophrenic patients
Frequency of acute exacerbations in schizophrenic patients At least one episode of acute exacerbation over 1st year 7 9 11 13 15 17 months Months months months months months 8 10 12 14 16 18 months months months months months months The incidence of acute episodes is particularly high in the 5 years
Slide 11: Antipsychotic treatment
Antipsychotic treatment • Antipsychotic is a psychiatric medication that works by helping to restore the balance of certain natural substances in the brain (neurotransmitters). • Antipsychotics are most frequently used for the following conditions: schizophrenia, schizoaffective disorder, bipolar di
Slide 12: Second generation antipsychotics (SGA)
Second generation antipsychotics (SGA) • The second-generation (atypical) antipsychotic (SGA) drugs promised enhanced efficacy and safety of first generation. This drugs may be administrated daily (oral) or monthly (injectable). • The molecules used in the second-generation are risperidone, paliperi
Slide 13: Problem of Non-Adherence
Problem of Non-Adherence • The development of new drug formulations that improve the pharmacokinetic profile and lengthen the dosing interval could contribute to increase the treatment adherence. • The discontinuation rates of oral antipsychotics in chronic schizophrenia have been estimated to be as
Slide 14: LAIs are becoming the goal standard
LAIs are becoming the goal standard Last Resort The LAIs 5 4 3 2 Most schizophrenia patients (approximately 80% Fourth Relapse Institutionalize to 90%) experience a relapse during the course of 1 Consolidate Third Relapse their illness. Breakthrough psychotic episodes Small wins may result from nona
Slide 15: LAIs: Superior outcome value
LAIs: Superior outcome value • LAIs provide a superior new approach to the treatment of schizophrenia aimed to reduce the relapses which provoke the progression of irreversible and cognitive brain damages. Monthly dose medically supervised takes away the responsibility of remembering from patients a
Slide 16: ISM® technology
7 ISM® technology
Slide 17: ISM®: Robust technology
ISM®: Robust technology • ROVI has developed a sustained-release injectable technology called ISM® (in-situ microparticles) based in two separated syringes containing a) the drug and polymer (solid state), and b) the solvent (liquid state). • The ISM® technology is protected by patents until 2033. •
Slide 18: DORIA®
DORIA®
Slide 19: DORIA®: The fast onset of action long-acting injectable of risperidone
DORIA®: The fast onset of action long-acting injectable of risperidone • DORIA® offers ROVI an excellent opportunity to launch an efficiency proven active principle with an innovative system to delivery Active Principle: Novel Drug Delivery Clinical Development RISPERIDONE System: ISM® Program Uniqu
Slide 20: Drug development plan of DORIA®
Drug development plan of DORIA® 2008 Non-clinical Studies 2010 PHASE I Healthy Volunteers; Single dose; PK; Safety and Tolerability Chronic Toxicology 2013 PHASE I (PRISMA-1) Manufacturing development process Patients with schizophrenia, Single dose; PK; Safety and Tolerability PK pop / Modeling & S
Slide 21: DORIA®: Drug Development Plan (Phase II)
DORIA®: Drug Development Plan (Phase II) Gluteus OBJECTIVE: - Define the PK profile of DORIA® at the steady state - Evaluate the PK profile after IM administration at gluteal or deltoid muscle Screening (N=93) Randomization (N=70) Deltoid Deltoid: 75 mg Gluteus: 75 mg • DORIA® has therapeutic levels
Slide 22: DORIA®: Conclusions Phase I & Phase II
DORIA®: Drug Development Plan Conclusions Phase I & Phase II Therapeutic levels from the Suitable for a 4-weekly IM first hours after first injection (gluteus or deltoids) administration No oral supplementation is Similar safety profile as to required Risperdal/Risperdal Consta® Modeling and simulat
Slide 23: DORIA®: PRISMA-3 study. Phase III
DORIA®: PRISMA-3 study. Phase III • Phase III, PRISMA 3, is recruiting since May 2017 • It is double-blind (+open–label extension), parallel, multicentre (31 sites/ 2 countries). The objectives of Phase III are: • Evaluate the efficacy and safety of DORIA® as compared with that of placebo in the tre
Slide 24: DORIA® - PRISMA-3 study: Efficacy variables
DORIA® - PRISMA-3 study: Efficacy variables • Endpoint: Study day 85 or the last post-baseline double-blind assessment variable Primary efficacy • PANSS* total score mean change from baseline to endpoint Secondary variable efficacy • CGI-S** score mean change from baseline to endpoint • Improve CGI-
Slide 25: DORIA® - PRISMA-3 study: HEOR variables
DORIA® - PRISMA-3 study: HEOR variables • Resources used within and outside the participating center • By-resource use category (e.g., inpatient services, outpatient services) and total direct medical costs: ➢ Time to discharge and hospitalizations, ➢ Outpatient/ambulatory visits Health Resource ➢ H
Slide 26: DORIA®: Comparative bioavailability
DORIA®: Comparative bioavailability Objectives: • Assess the comparative bioavailability at the steady state of DORIA® versus oral risperidone in patients with schizophrenia. • Supportive bridge from oral risperidone data. Phase I, 2-stages, 1-sequence, open-label, multiple doses, multicentre Patien
Slide 27: DORIA®: Regulatory Strategy
DORIA®: Regulatory Strategy • Pre-IND meeting • Scientific Advice • End of Phase II meeting • Special Protocol Assessment NDA under 505(b)(2) Hybrid Application Section of FD&C Act [Article 10(3) - Directive 2001/83/EC] Treatment of Acute Exacerbation Treatment of Schizophrenia of Schizophrenia IND:
Slide 28: DORIA®: Innovation for unmet medical needs in Schizophrenia
DORIA®: Innovation for unmet medical needs in Schizophrenia INVEGA INVEGA ABILIFY ARISTADA® RISPERDAL RBP-7000 SUSTENNA® TRINZA® / MAINTENA® (Aripiprazole DORIA® 4 CONSTA® (Risperidone / XEPLION® TREVICTA® (Aripiprazole) Lauroxil) (Risperidone) (Risperidone) Atrigel®) 4 (Paliperidone) (Paliperidone)
Slide 29: DORIA®: Predictable and solid clinical outcome
DORIA®: Predictable and solid clinical outcome Rapid achievement of Treatment of therapeutic levels Fast onset of acute (8h). action Indication exacerbation of No oral schizophrenia supplementation Doses Safety DORIA® 4-weekly Good tolerability. administration of Efficacy in patients risperidone as
Slide 30: US and Top-5 European Schizophrenia Markets
US and Top-5 European Schizophrenia Markets
Slide 31: IMS data and Kantar Health
IMS data and Kantar Health • ROVI primarily needed to assess the commercial potential of DORIA® and gain a better understanding of the schizophrenia market trends over the long term in order to prepare the future commercialization of the product. • The market research objective is to identify the ma
Slide 32: Antipsychotics market in US
Antipsychotics market in US* US antipsychotic market (US Mn) • US is the largest antipsychotics market* 1.950 15.000 worldwide with 2015** sales of $14.2Bn. 1.850 14.000 1.750 13.000 • In terms of value, oral represents 87% and 1.650 12.000 injectable 13% of total antipsychotic sales 1.550 11.000 1.
Slide 33: Schizophrenia injectable market in US
Schizophrenia injectable market in US* • US is the largest schizophrenia US schizophrenia injectable market (US Mn) injectable market worldwide with 2.900 annual sales in 2015 of $1.3Bn and 2.436 2.315 2.494 2.499 2.400 2.301 1.4Mn units. 1.969 1.900 • The market has grown +25% CAGR (2011-2015) in v
Slide 34: Antipsychotics market in Top-5 Europe
Antipsychotics market in Top-5 Europe* • Top5 largest markets in Europe are France, Germany, Italy, Spain and UK. Top5 Europe antipsychotic market (US Mn) 850 2.200 • Top5 market is one of the top 800 2.100 antipsychotics market worldwide with 750 2.000 2015** sales of with $2.6Bn. 1.900 700 1.800 •
Slide 35: Schizophrenia injectable market in Top5 Europe
Schizophrenia injectable market in Top5 Europe* Top 5 European schizophrenia injectable market (US Mn) • Top 5 Europe has a schizophrenia 1.000 930 injectable market sales of $520Mn 900 869 and 2.1Mn units in 2015. 765 800 • The market has grown +7% CAGR 700 662 (2011-2015) in value and +4% CAGR 600
Slide 36: DORIA®: ROVI's strategy
DORIA®: ROVI’s strategy • The strategy of the Company related to DORIA® is aligned R&D team fully Owner of Manufacturing Plants Limited Sales Force dedicated technology • DORIA® requires a • GMP & FDA plants. small sales force • Quality proved so reduces • ISM® projects because medical • The ISM® ri
Slide 37: Update on Enoxaparin and Letrozole ISM®
Update on Enoxaparin and Letrozol ISM®
Slide 38: Enoxaparin business
Enoxaparin business • In September, ROVI announced the commence of the enoxaparin marketing in Germany. • ROVI is following a double strategy in distributing the biosimilar of enoxaparin, based on: • Local offices have been registered in Top ✓ Rovi GmbH: Germany Direct presence in some 5 European co
Slide 39: Letrozole ISM®: LISA-1 study
Letrozole ISM®: LISA-1 study • Letrozole is the key treatment for breast cancer hormone receptor+ Breast cancer Aromatase Inhibitors • The annual incidence of breast cancer in • Aromatase inhibitors (AI), letrozole, Europe is 110/100,000 and it is the main anastrozole and exemestane, block the cause
Slide 40: Letrozole ISM®: LISA-1 study
Letrozole ISM®: LISA-1 study • The objective is to obtaining a long-term injectable formulation of letrozole and its inclusion in the market for maintenance treatment in breast cancer in post-menopausal HR + women. • Potential advantages are: - First injectable depot of an aromatase inhibitor - Impr
Slide 41: Projections of R&D costs
7 Projections of R&D costs
Slide 42: Projections of R&D costs
Projections of R&D costs* • ROVI will need an important R&D investment for the coming years, to develop DORIA® Phase III together with Letrozole ISM® Phase I. • This cost will be the pillars for future growth. • In the period 2017-2019, the average cost of R&D will be around €32Mn per year. ➢ 76% of
Slide 43: Conclusions
7 Conclusions Pee (ae
Slide 44: Conclusions
Conclusions • ROVI is going through a transformational moment launching our biosimilar of enoxaparin in Europe and the evolution of our R&D pipeline. • In-house products will be an important % of total sales in the coming years and international presence will increase significantly and will make ROV
Slide 45: DORIA®: An optimal profile for a LAI
DORIA®: An optimal profile for a LAI Monthly injection for a fully medical supervision in the medical setting: Providing a mechanism for monitoring adherence with injections Regular interactions between patient and medical staff Medical target: Psychiatrist in acute medical setting Small sales force
Slide 46: Slide 46
Laboratorios Farmacéuticos Rovi — Investor Presentation (2017) on 6ix