Laboratorios Farmaceuticos Rovi, S.a. · BME:ROVI
Laboratorios Farmaceuticos Rovi — Corporate Update (March 2021)
8 slides from Laboratorios Farmaceuticos Rovi's corporate update, March 2021
Slide 1: Update on Doria regulatory processes
Update on Doria® regulatory processes MARCH 2021
Slide 2: Disclaimer
Disclaimer • This Presentation has been prepared by Laboratorios Farmacéuticos Rovi, S.A. (the “Company”) and comprises the slides for a presentation concerning the Company and its subsidiaries (the “Group”). For the purposes of this disclaimer, “Presentation” means this document, its contents or an
Slide 3: European regulatory process – Where we are?
European regulatory process – Where we are? 16 November We are here 2021 D.1 D.120 D.121 D.180 D.181 D.210 D.277 Primary Secondary Final Decision Validation Evaluation Evaluation evaluation Making List of List of Outstanding Responses Issues Responses Opinion EC decision Questions ROVI requests a cl
Slide 4: Therapeutic Indication – Covering the Unmet Medical Need (1/2)
Therapeutic Indication – Covering the Unmet Medical Need (1/2) Requested Therapeutic Indication to EMA Treatment of Schizophrenia in adults Doria® would be the ONLY1 Long-Acting Injectable Antipsychotic that can be administered to unstable patients with severe or moderate psychotic symptoms sufferin
Slide 5: Therapeutic Indication – Covering the Unmet Medical Need (2/2)
Therapeutic Indication – Covering the Unmet Medical Need (2/2) Doria® has a unique Pharmacokinetic profile making the product suitable to treat stable schizophrenia patients as well as unstable schizophrenia patients requiring a fast onset of action SUSTAINED THERAPEUTIC LEVELS ACHIEVES FAST THERAPE
Slide 6: USA regulatory process – Where we are?
USA regulatory process – Where we are? The recommended follow-up phases FDA completed its filing with the FDA1 review and determined that were covered: ROVI application is • Pre-IND2 sufficiently complete to • IND2 permit a substantive review. • End of phase II Application3 considered • Pre-submissi
Slide 7: Product Launch (subject to obtaining the relevant authorisations)
Product Launch (subject to obtaining the relevant authorisations) Due to the COVID-19 pandemic, the launch of the product would probably have been Commercialization in Europe Commercialization in USA delayed until the market conditions were more favorable Doria® expected to be launched in Europe
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