Laboratorios Farmaceuticos Rovi S A : The Company releases a presentation related to an update of the regulatory processes of its long-acting injectable antipsychotic, Doria®, both in Europe and the United States

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European regulatory process - Where we are?

16 November 2021

List of Questions

List of Outstanding

Responses

Issues

ROVI requests a clock-stop to answer a major objection: Repeat BORIS1 study with European reference product

•  Objective: repetition of BORIS1 study using Risperdal® 2 marketed in EU

•  BORIS1 study is a clinical trial which compares the pharmacokinetics of Doria ® vs oral risperidone medicine, Risperdal®. Risperdal®2 marketed in USA was used in the BORIS1 study.

•  ROVI expected the trial using Risperdal® 2 marketed in USA to be valid for Europe as Risperdal® 2 marketed in USA and Risperdal® 2 marketed in EU can be considered bioequivalents based on the in vitro and in vivo studies conducted by ROVI

•  A second major objection was received to avoid issues related to the potential lack of flexibility when starting with a long-acting formulation. It is expected to be solved with proposed changes in Product Information.

•  Other non-major concerns pending to be answered in D181.

Responses

Opinion

Limited clinical risk

Cost of around €6Mn

EC decision

Clock-stop for D181 response granted by CHMP3: New information to be provided in November 2021

Therapeutic Indication - Covering the Unmet Medical Need (1/2)

Requested Therapeutic Indication to EMATreatment 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 suffering a relapse

•  Dynamic market originating in hospitals

•  In Germany and UK, around 72% of prescriptions in hospitals correspond to patients who start treatment with a LAI2

•  Competitive advantage because of the potential unique indication of Doria®