Madrid – 2 April, 2024 – Today, Laboratorios Farmacéuticos Rovi, S.A. (“ROVI” or the “Company”) has announced that the U.S. Food and Drug Administration (FDA) has authorised the marketing of Risvan® (Risperidone ISM®) for the treatment of schizophrenia in adults.

Risperidone ISM® is a prolonged-release injectable antipsychotic developed and patented by ROVI for the treatment of schizophrenia in adults, which, as of the first injection, provides immediate and sustained plasmatic drug levels and does not require loading doses or supplementation with oral risperidone.

This approval is based on the positive results of the pivotal PRISMA-3 study on the efficacy and safety of Risperidone ISM® in schizophrenia patients. The results obtained in this study show that the two different doses (75 mg and 100 mg once a month) have achieved the prespecified primary and secondary efficacy endpoints for treatment of patients with moderate to severe symptoms of schizophrenia. The primary efficacy endpoint, the PANSS total score (mean difference, CI: 95%), improved significantly with Risperidone ISM® 75 mg and 100 mg from the beginning until day 85, with adjusted differences of -13.0 (17.3 to -8-8; p <0.0001) and -13.3 (-17.6 to -8.9; p<0.0001), respectively, in comparison with the placebo. Significantly improved mean changes for the secondary endpoint, the CGI-S score, were also obtained for Risperidone ISM® in comparison with the placebo, -0.7 (-1.0 to -0.5; p<0.0001), for both doses, from the beginning until day 85. The significant statistical improvement for both efficacy results was observed as early as 8 days after the first injection. The most frequently reported treatment-emergent adverse events were increased blood prolactin (7.8%), headaches (7.3%), hyperprolactinemia (5%) and weight increase (4.8%). No important new or unexpected safety information was reported. Likewise, patients who successfully completed the double-blind period were offered the opportunity to continue in a long-term, open-label 12-month extension phase with once every four weeks injections of Risperidone ISM® (75 mg or 100 mg). New, clinically stable patients ("de novo" patients) were also able to enter this open phase of the study. Long-term treatment was observed to be effective, safe and well tolerated in adult patients with schizophrenia, regardless the initial severity of the disease or whether they had been treated previously with Risperidone ISM® during an acute exacerbation or switched from stable doses of oral risperidone. Likewise, Risperidone ISM® provided a swift and sustained improvement in functioning (both social and personal) and health-related quality of life. These findings, together with a quick onset of effectiveness, could help strengthen the therapeutic alliance and possibly lead to an earlier hospital discharge. Furthermore, the patient’s functioning either continued to improve or remained stable with long-term treatment.

"We are very excited about the FDA’s approval of Risvan® because we think our medicine will be able to contribute to the clinical management of schizophrenia patients, helping to improve treatment adherence”, commented Juan López-Belmonte Encina, ROVI’s Chairman and Chief Executive Officer.

About schizophrenia
Schizophrenia is a chronic, serious and disabling mental disorder that affects around 1% of the world population. Schizophrenia patients are characterised by a mixture of symptoms, both positive (delusional ideas, hallucinations, disorganized language and behaviour) and negative (affective flattening, speech poverty, abulia) in nature. The disease usually starts at an age that is critical for personal development, often forcing patients to leave their educational or work activity and resulting in a great deal of suffering for the patients and their family environment, as well as an important loss for society. It is estimated that between 3% and 5% of total global healthcare expenditure is spent on schizophrenia.

About the 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 for oral co-administration, additional boosters or loading injections to achieve and maintain the levels in a predictable and sustained manner, thus having a greater likelihood of meeting the patient's clinical needs.

About ROVI
ROVI is a pan-European pharmaceutical company specializing and engaging in the research, development, contract manufacturing and marketing of small molecules and
biological specialties. The company, in a continuous international expansion process, has subsidiaries in Portugal, Germany, the United Kingdom, Italy, France and Poland and has a diversified marketing portfolio of more than 40 products, among which its flagship product, Bemiparin, already present in more than 60 countries all over the world, should be highlighted. Likewise, in 2017, ROVI commenced the marketing of its Enoxaparin biosimilar, developed in-house, in Europe and it is already marketed in 40 countries. ROVI continues to develop the ISM® Platform technology, a leading-edge line of research in the field of prolonged drug release with proven advantages. For more information, please visit ww.rovi.es.