Christmas message from Juan López-Belmonte, Chairman and Chief Executive Officer of ROVI.
Merry Christmas and Happy New Year
Reminder Use of notification box COVID-19
In order to optimise the management of the queries we receive to the mailbox notificacionescovid19@rovi.es, we remind you that it is necessary to identify the name of the employee and their work centre in the subject line of the email.
Remember that if you have symptoms associated with covid-19 or any suspicion of contact with infected people, you should contact your health centre and follow their instructions. You should also report any such incidents to ROVI’s mailbox, as well as any doubts or queries that arise in connection with covid-19.
ROVI moves forward in the approval of its drug Risperidone ISM® for schizophrenia
Laboratorios Farmacéuticos Rovi, a pan-European pharmaceutical company specializing and engaging in the research, development, contract manufacturing and marketing of pharmaceutical products, has announced that the Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of ROVI’s product Risperidone ISM® -commercially known as Okedi®- for adult patients with schizophrenia.
This medicine is a monthly injectable antipsychotic developed and patented by ROVI for the treatment of schizophrenia in adults for whom the tolerability and effectiveness has been established with oral risperidone, since, as of the first injection, it provides immediate and sustained plasmatic drug levels and does not require loading doses or supplementation with oral risperidone. “We are very excited and satisfied at receiving the favourable recommendation of the CHMP because we believe that our product can contribute to the clinical management of schizophrenia patients”, commented Juan López-Belmonte Encina, ROVI’s Chairman and Chief Executive Officer.
The positive opinion of the CHMP is based on the positive results of the PRISMA-3 study on the efficacy and safety of the treatment. The results obtained in this study show that the prespecified primary and secondary efficacy endpoints were achieved with two different doses (75mg and 100 mg monthly) for the treatment of patients with acute exacerbation of schizophrenia. The primary efficacy endpoint improved significantly with the treatment from the beginning until Day 85. Significantly improved mean changes for the secondary endpoint were also obtained with the two doses. The significant statistical improvement for both efficacy results was observed as early as 8 days after the first injection.
The European Commission usually follows the recommendations of the CHMP (EMA), issuing its final decision on the basis thereof. The approval of this new drug is expected in approximately 60 days’ time and it could be launched in Europe in the
second quarter of 2022. Regarding other territories, ROVI filed the application for marketing authorisation for Okedi® with the United State Health authorities, the U.S. Food and Drug Administration (“FDA”), on 24 November, 2020 and the dossier is currently being reviewed by this agency. The new Risperidone ISM® product will increase the diversified portfolio of more than 40 products currently marketed by ROVI.
In Spain, there are around 600,000 people with schizophrenia or associated disorders. Schizophrenia is a chronic, serious and disabling mental disorder 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 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 global health expenditure is devoted to schizophrenia.
The Mayor of Alcalá de Henares visits ROVI Laboratories
The Alcalá de Henares plant was visited by the mayor of the city, Javier Rodríguez Palacio, accompanied by the councillor responsible for Urban Planning, Alberto Blázquez Sánchez, and the manager of the Ente Público Empresarial Alcalá Desarrollo, Pilar Fernández Herrador.
Accompanied by the vice-president and CFO, Javier López-Belmonte; the director of the Industrial Area, Miguel Ángel Ortega; and the director of the plant, Pilar García-Morato, the mayor was shown the production activity of the plant, which has an annual production capacity of 3,000 million tablets per year, 100 million final packaged units and 150 million packaged syringes.
During the visit, ROVI management showed the state-of-the-art facilities, highlighting the 12 packaging lines (seven dedicated to injectables) that make it a packaging centre of excellence for in-house and third-party manufacturing. The mayor was also interested in the increased investment in the Alcalá plant and the development of new projects there.
The plant had previously received a visit from the city council of Alcalá de Henares, specifically from the councillor for equality, Patricia Sánchez, who also praised its social initiatives, as well as its participation in the “Empléate desde la Igualdad” programme for reintegrating women into the labour market.
Christmas dinners
We would like to remind you that from next Monday new prevention measures will come into force at ROVI in response to covid-19. These measures are motivated by the increase in the number of infections in the country and the uncertainty caused by the emergence of the omicron variant in the management of the pandemic.
Unfortunately, despite the high vaccination rates, the risk of infection in the face-to-face activities has been increasing in recent weeks. ROVI’s management already took the difficult decision months ago not to hold this year’s traditional Christmas dinner for employees for the second year in a row.
The actual context makes it inadvisable to hold large events in enclosed spaces where minimum prevention measures such as safety distance or the continuous use of masks cannot be guaranteed.
Similarly, we urge departments planning to hold employee Christmas gatherings in the coming weeks to refrain from holding them. We understand that this time of year is a time for celebration and sharing, but we must remember that the only way to prevent infection is to avoid risky situations.
ROVI joins in the IBEX 35 in December
The Technical Advisory Committee (CAT) has approved this Thursday the inclusion of Laboratorios Farmacéuticos ROVI in the IBEX 35, the main stock market index in Spain. Inclusion in the IBEX is a decision taken on purely technical criteria. As of 20 December, ROVI’s share price will be included in the Spanish selective index, replacing Viscofan.
As a company, being part of the main index of the Spanish Stock Exchange is a stimulus and an incentive for all the professionals who make up ROVI to continue with the work and dedication that has already led us to be considered as one of the world’s leading companies in the pharmaceutical sector.
Join the Race for Enterprise 2021
The Race for Enterprise 2021 is here!
Make your team of 2, 3 or 4 runners and show your teammates who is the fastest. If you don’t have a team, don’t worry: we’ll find you one.
If you are not in Madrid but you want to participate in the race, you can sign up in the virtual mode.
What are you waiting for?
- Date: 19 December at 09:00 am
- Place: Plaza San Juan de la Cruz (Madrid)
- Distances: 6.5 km and 10 km
You have until 10 December