ROVI filed its application for marketing authorisation for Doria® with the European health authorities, the European Medicines Agency (EMA), through the Centralised Procedure on 27 December, 2019. After passing the validation phase satisfactorily, the dossier was admitted for evaluation on 30 January, 2020.

It is forecast that the assessment phase of the Centralised Procedure used by the Company to register this medicine in the EU may take around one year. It should, however, be noted that the assessment process is subject to interruptions and delays in the event that the European health authorities require additional information. Likewise, mention should be made of the fact that the outcome of the registration process (which may be positive or negative) cannot be known until it has concluded.

ROVI will continue to provide information on the milestones deemed significant in this authorisation as the calendar for registration of the medicine in the European Union advances, as well as the registration of the same medicine with the U.S. Food and Drug Administration (FDA), which it is planned to commence in the second half of 2020.

“We are continuing to progress with the approval phase of Doria® and are now closer to marketing it. We have confidence in the product’s potential and hope that we will soon be able to offer a therapeutic alternative for the treatment of this chronic, serious and progressive disorder”, said Juan López-Belmonte, ROVI’s Chief Executive Officer.

About schizophrenia

Schizophrenia is a chronic, serious, and disabling mental disorder that affects about 1% of the population. Schizophrenia patients are characterized by a mixture of psychiatric symptoms, both positive (delusional ideas, hallucinations, disorganized language and behaviour) as negative (affective flattening, speech poverty, abulia) in nature. The disease usually starts at a critical age for personal development, forcing patients in many cases to leave their educational or work activity, resulting in a great deal of suffering for the subjects and their family environment as well as representing an important loss for society at large. It is estimated that approximately 3% to 5% of total health expenditure is devoted to schizophrenia.

About ISM® Technology

ISM® is a Technology Platform for the release of drugs, patented by ROVI, which is based on the in situ formation of biodegradable matrices after the administration of a liquid carrier. Its unique characteristics allow therapeutic levels of the medicine to be obtained quickly after its administration, without the need to for oral coadministration or additional booster or loading injections to achieve and maintain the levels in a predictable and sustained manner, which has a greater likelihood of satisfying the patient's clinical needs.