Month: October 2021

Laboratorios Farmacéuticos Rovi, S.A. has been informed of the delay in the decision on the granting of marketing authorisation for Risperidone ISM® by the U.S. Food and Drug Administration (“FDA”). The FDA will be taking a number of actions, including an in-situ inspection of the European production plant where the product is manufactured, located in Madrid (Spain). The grant of the marketing authorisation for Risperidone ISM® by the FDA is subject to the result of this inspection.

The delay in the inspection of the manufacturing facilities has been caused by the restrictions on movement due to COVID-19 and, thus, the FDA has not yet fixed the inspection date.

ROVI filed the application for marketing authorisation for Risperidone ISM® with the FDA on 24 November, 2020. On 24 September, 2021, ROVI received a Complete Response Letter from the FDA with outstanding questions on the Risperidone ISM® dossier. The Company has either answered them or will be answering them in the near future since, in its letter, the FDA recognises that it did not review some of the responses submitted during the evaluation process. ROVI expects its responses to clarify the outstanding questions.

In the Complete Response Letter, the FDA states that, due to the exceptional situation caused by the pandemic which has prevented the inspection from taking place within

the term defined in the Filing Communication Letter, all the responses to outstanding questions will be evaluated in accordance with the timeline described in the “2020 Guidance for Industry Review Timelines for Applicant Reponses to Complete Response Letters When a Facility Assessment Is Needed During the COVID-19 Public Health Emergency”, with an estimated review time of 6 months as of the submission of the responses to the questions raised in the Complete Response Letter.

Risperidone ISM® is a novel, once-monthly, injectable antipsychotic, currently in the research phase, for the treatment of schizophrenia, developed and patented by ROVI. As of the first injection, it provides immediate and sustained plasma drug levels of the medicine, without the need for loading doses or supplementation with oral risperidone.

Haven’t you signed up for the Madrid También Solidario race yet?

Run with us on Sunday 7 November at 10am for the inclusion and accessibility of people with disabilities.

Register for the race HERE

We encourage you to participate with your family and friends. There are three modalities:

• 10km and 5km running, handbike or wheelchair.
• 1km for inclusion. Ideal to do with the little ones

The funds raised will be donated to the sports programmes of the También Foundation, which works for the inclusion of people with disabilities and promotes education in values through adapted sport.

Do you want to know more about the race? Click HERE

The Andalusian Minister of Health and Families, Jesús Aguirre Muñoz, took part in the informative act organised by the Granada newspaper Ideal and sponsored by Laboratorios Farmacéuticos ROVI. During his speech, the Minister reviewed the data on vaccination against covid-19 in the region, where more than 90% of those over 12 years of age have completed the vaccination schedule.

Aguirre Muñoz also reviewed his plans to strengthen the region’s healthcare services in the coming years, with a commitment to increasing investment in primary care, as well as the forecasts for the recruitment of healthcare professionals.

ROVI has obtained the 17th place in the Reporta Report and climbs five positions with respect to 2020 in this classification that assesses the quality of the information of 120 companies of the General Index of the Madrid Stock Exchange. With this, it takes the lead in the “Consumer goods” sector, ahead of Iberpapel (18th) and Inditex (20th)

This is a study carried out by the consulting firm DEVA and that each year assesses the quality of the companies’ annual integrated reports with respect to 36 indicators grouped into 4 principles: transparency, relevance, accessibility and commitment. Banco de Santander, Telefónica and Cie Automotive are the companies that lead this year’s ranking.

In the case of ROVI, it has gone from the 22nd position in 2020 to the 17th in 2021, which also makes it the pharmaceutical laboratory with the best scores, ahead of Grifols (30th), Prim (56th), Almirall (75th) and Pharma Mar (70th). The average score obtained by ROVI is 73.4 points, well above the average for the index, which stands at 46.7 points.

If you want to check the ranking, you will find it in this link

Run with us on Sunday 7 November at 10am for the inclusion and accessibility of people with disabilities.

What are you waiting for?

Three modalities:

• 10km and 5km running, handbike or wheelchair.
• 1km for inclusion. Perfect to do it with the kids

The funds raised will go to the sports programmes of the También Foundation, which works for the inclusion of people with disabilities and promotes education in values through adapted sport.

SIGN UP HERE

You have until 21 October

The deadline for signing up for ROVI’s flu vaccination campaign is 15 October. If you haven’t already done so, you have these options for signing up:

1. Send an email to the mailbox vaccinate@rovi.es with the following information: full name, ID and work centre.
2. Submit a signed written form to the Safety and Environment (SYMA) of your work centre that you will find in the security checkpoints of the plants.

• Julián Camarillo: pfacenda@rovi.es / echamorro@rovi.es
• Pozuelo and Building H: afernandez@rovi.es
• Granada: lnuno@rovi.es / rlanzas@rovi.es
• Alcalá: epalomino@rovi.es / aiborra@rovi.es
• San Sebastián de los Reyes: mnaranjo@rovi.es

The internal flu vaccination campaign for all employees who wish to be vaccinated will take place between 25 October and 12 November 2021. Each employee will be assigned a specific vaccination schedule.

Why is it important to get a flu shot?

• The flu is an infectious respiratory disease caused by a virus. Flu viruses can cause mild or severe illness and can sometimes lead to death.
• Vaccination is the most effective strategy to reduce the chances of infection among the general population, with a special focus on risk groups.
• At ROVI we support this strategy of the authorities and we understand that, in the context of the current pandemic, it is essential to promote compliance with the vaccination objectives of the autonomous communities, reduce the risk of influenza contagion among the most vulnerable population and minimize the care burden of health resources.

Vaccine Information

In the following link you will find all the information about the flu vaccine, how it works, the risk groups, its contraindications, etc. We recommend that you read it so that you can make an informed decision.

https://www.mscbs.gob.es/profesionales/saludPublica/prevPromocion/vacunaciones/programasDeVacunacion/gripe/faq/home.htm

If you want to know more about the vaccine that we will provide (quadrivalent and cell culture), you will find all the information in this link, including information on adverse effects:

https://www.mscbs.gob.es/profesionales/saludPublica/prevPromocion/vacunaciones/programasDeVacunacion/gripe/faq/home.htm

Likewise, below, we provide you with the relevant information regarding Data Protection:

Laboratorios Rovi, SA and its subsidiaries (hereinafter, “ROVI”; or “GRUPO ROVI”, indistinctly), with registered office at C / Julián Camarillo, 35, 28037, Madrid and CIF A-28041283, will process the identification and contact data (name, workplace and ID) of the workers who sign up for the ordinary flu Vaccination campaign that will take place on day [-], in order to manage it. The processing of these data is necessary for your vaccination.

The legal basis that legitimizes the processing of your data is the consent given by you when registering for the Vaccination campaign. The data will be kept for the duration of the employment relationship and, once it has ended, for the period determined by the applicable legislation at all times.

The above data will be transferred to Quirónsalud Hospital Group, external medical service to which we have arranged to carry out the campaign, to allow you to identify yourself as a ROVI employee. Once received, the Quirónsalud Hospital Group You will be fully responsible for the treatment of the data provided by ROVI and the rest of the data provided by you directly, which will be treated under your sole responsibility and in accordance with the provisions of your own Privacy Policy. Likewise, your data may be transferred to third parties to whom ROVI is obliged to transmit information, such as public authorities.

The worker may exercise their rights of access, rectification, cancellation / deletion, opposition, limitation and portability through written communication to [-], identifying themselves as an employee of one of the ROVI GROUP companies, providing a photocopy of their ID or equivalent document and specifying your request. The cancellation or opposition rights may not be exercised when their granting prevents the proper development and fulfilment of the contractual relationship. Likewise, if they consider their right to personal data protection violated, they may file a claim with the Spanish Data Protection Agency ( www.aepd.es ).

If you wish, you can consult the additional and detailed information on Data Protection by contacting our Data Protection Delegate at: dporovi@rovi.es .

One more year, ROVI joins the recommendation of the health authorities and will facilitate the possibility of getting vaccinated against the common flu to all employees who so wish.

Why is it important to get a flu shot?

• The flu is an infectious respiratory disease caused by a virus. Flu viruses can cause mild or severe illness and can sometimes lead to death.
• Vaccination is the most effective strategy to reduce the chances of infection among the general population, with a special focus on risk groups.
• At ROVI we support this strategy of the authorities and we understand that, in the context of the current pandemic, it is essential to promote compliance with the vaccination objectives of the autonomous communities, reduce the risk of influenza contagion among the most vulnerable population and minimize the care burden of health resources.

For this reason, this year we will carry out an internal flu vaccination campaign for all employees who wish to do so, between October 25 and November 12, 2021.

Those employees who are interested in getting vaccinated can enrol in one of the following ways:

1. Send an email to the mailbox vaccinate@rovi.es with the following information: full name, ID and work centre.
2. Submit a signed written form to the Safety and Environment (SYMA) of your work centre that you will find in the security checkpoints of the plants.

• Julián Camarillo: pfacenda@rovi.es / echamorro@rovi.es
• Pozuelo and Building H: afernandez@rovi.es
• Granada: lnuno@rovi.es / rlanzas@rovi.es
• Alcalá: epalomino@rovi.es / aiborra@rovi.es
• San Sebastián de los Reyes: mnaranjo@rovi.es

Registration must be sent before October 15, so that we can properly organize vaccination shifts.

Vaccine Information

In the following link you will find all the information about the flu vaccine, how it works, the risk groups, its contraindications, etc. We recommend that you read it so that you can make an informed decision.

https://www.mscbs.gob.es/profesionales/saludPublica/prevPromocion/vacunaciones/programasDeVacunacion/gripe/faq/home.htm

If you want to know more about the vaccine that we will provide (quadrivalent and cell culture), you will find all the information in this link, including information on adverse effects:

https://www.mscbs.gob.es/profesionales/saludPublica/prevPromocion/vacunaciones/programasDeVacunacion/gripe/faq/home.htm

Likewise, below, we provide you with the relevant information regarding Data Protection:

Laboratorios Rovi, SA and its subsidiaries (hereinafter, “ROVI”; or “GRUPO ROVI”, indistinctly), with registered office at C / Julián Camarillo, 35, 28037, Madrid and CIF A-28041283, will process the identification and contact data (name, workplace and ID) of the workers who sign up for the ordinary flu Vaccination campaign that will take place on day [-], in order to manage it. The processing of these data is necessary for your vaccination.

The legal basis that legitimizes the processing of your data is the consent given by you when registering for the Vaccination campaign. The data will be kept for the duration of the employment relationship and, once it has ended, for the period determined by the applicable legislation at all times.

The above data will be transferred to Quirónsalud Hospital Group, external medical service to which we have arranged to carry out the campaign, to allow you to identify yourself as a ROVI employee. Once received, the Quirónsalud Hospital Group You will be fully responsible for the treatment of the data provided by ROVI and the rest of the data provided by you directly, which will be treated under your sole responsibility and in accordance with the provisions of your own Privacy Policy. Likewise, your data may be transferred to third parties to whom ROVI is obliged to transmit information, such as public authorities.

The worker may exercise their rights of access, rectification, cancellation / deletion, opposition, limitation and portability through written communication to [-], identifying themselves as an employee of one of the ROVI GROUP companies, providing a photocopy of their ID or equivalent document and specifying your request. The cancellation or opposition rights may not be exercised when their granting prevents the proper development and fulfilment of the contractual relationship. Likewise, if they consider their right to personal data protection violated, they may file a claim with the Spanish Data Protection Agency ( www.aepd.es ). If you wish, you can consult the additional and detailed information on Data Protection by contacting our Data Protection Delegate at: dporovi@rovi.es .