Laboratorios Farmacéuticos Rovi, S.A.
We are a specialized pharmaceutical company engaged in the research, development, manufacture and marketing of pharmaceutical products. Our operations encompass the marketing of both our own and licensed products and the provision of services, such as production, filling and packaging, to other companies. ROVI´s dedication and its strategy of encouraging the international trade, has led to extend Bemiparin presence, whether in pre-registration, registration or marketing stage, to a total of 88 countries thanks to the strategic alliances established with our 22 international partners.
Company details
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- Business Type:
- Manufacturer
- Industry Type:
- Pharmaceuticals
- Market Focus:
- Globally (various continents)
About us
More than 70 years researching and improving health
1946
Foundation of the Company
1981
Beginning of research into low-molecular-weight heparins
1998
Launch of Bemiparin on the Spanish market and start-up of cooperations in Portugal
2002
Internationalization of ROVI® following approval of Bemiparin outside Spain
2003
Increased International coverage to 59 countries
2006
Construction of the Granada R&D&i centre and plant
2007
Agreement with Laboratoires Servier for the marketing of Corlentor®
2009
Strategic agreement with Merck Sharp & Dhome (MSD)
2011
Agreement with MSD for the marketing of Vitorin® and Absorcol®
2012
FDA certification of the injectables plant
2013
Agreements to market products from Novartis and Medice
2014
registration process for an enoxaparin biosimilar with the EU
2015
Adquisition of the new injectables plant in San Sebastián de los Reyes
Successful completion of PRISMA-2 study
Agreement with Astellas for the marketing of Volutsa®
2016
Agrement with Novartis for the marketing of Neparvis® and Orexigen for the marketing of Mysimba®
2017
Commencement of the marketing of an enoxaparin biosimilar in Germany
Beginning of Phase III clinical trial of Doria® (Risperidone-ISM®)
2018
Launch of an enoxaparin biosimilar in Spain, France, United Kingdom, Italy Austria, Estonia and Latvia
2019
Conclusion of the PRISMA-3 and BORIS studies and end of the Clinical Research Programme of Risperidone-ISM® - Doria® in patients with schizophrenia and application for marketing authorisation in Europe
Presence of enoxaparin biosimilar in 13 countries
2020
Validation of the Doria® dossier and start of the product evaluation process in Europe
Business Units
We are a specialized pharmaceutical company engaged in the research, development, manufacture and marketing of pharmaceutical products.
Our operations encompass the marketing of both our own and licensed products and the provision of services, such as production, filling and packaging, to other companies. We have three pillars of growth:
Pharmaceutical Products
Diversified portfolio of our own and licensed products, protected by patents
Contract Manufacturing
Specialists in prefilled syringes and solid oral forms
R&D
Solid, low-risk R&D&i policy
Strategy
Our strategy to continue growing and improve our market position is based essentially on:
Actively seeking strategic opportunities to market other companies’ products (in-licensing) in Spain and Portugal, either on an exclusive basis or under a system of co-marketing, co-branding or co-promotion and acquisition of products.
Entering into agreements granting marketing rights for our proprietary molecules (out-licensing) outside Spain.
Current lines of development: ROVI is focused on the development of prolonged-release injectables through the ISM® (In Situ Microparticles) platform.
Establishing co-operation on R&D projects with companies and/or universities (co-development).
Marketing new therapeutic indications developed for the products on our portfolio, the formulation of new products and the development of prolonged-release methods that enhance the efficiency and safety profiles of injectable compounds.
Strategic Priorities
Our growth engines are: bemiparin, the new distribution licenses (Neparvis®, Mysimba®, Volutsa®, Orvatez® and Ulunar®), the existing pharmaceutical product portfolio, the new licenses for products granted to other companies and the potential marketing of our enoxaparin biosimilar.
There is an agreement with MSD that will allow us to launch four additional products over the next two years, which we trust will contribute to the Company’s sustained long-term growth.
For ROVI, the pharmaceutical products marketed in Spain have a high strategic value, which will help to boost the importance of our presence over forthcoming years.
We also foresee that our importance will increase internationally, with our bet on the expansion of Bemiparin. This is why we have extended our presence to cover more than 55 countries.
Likewise, we hope to have a direct presence, with our enoxaparin biosimilar, in the main European markets and to expand our presence in the United States and emerging countries.
Our success is based on the constant effort we put into R&D. At present, we are concentrating on the glycomics and ISM® platform, the latter of which is our proprietary drug-released system, the objective of which is to improve patient adherence to treatment. We hope to commence the phase III clinical trial of Risperidone ISM®, the first candidate of our drug-release technology, used to treat schizophrenia, in the second quarter of 2017, after the success of the phase II “PRISMA-2” trial.
Additionally, it is forecast that the first clinical trials on humans with Letrozole ISM® (an aromatase inhibitor for the treatment of breast cancer) will begin in the second half of 2017.
We have a new plant that will allow us to manufacture new ISM® -technology products for high-power active substances, as is the case of Letrozole.
Regarding the glycomics area, we have successfully completed the decentralized procedure to register our enoxaparin biosimilar. Consequently, the national phase of the registration process, which will foreseeably conclude with the granting of marketing authorization by the respective national authorities of each country, has commenced.
We are striving to reinforce our contract manufacturing operations by acquiring new customers who help to maximize the potential of both our two injectables plants and the solid oral forms plant.
Both our Madrid injectables plant and our solid forms plant in Alcalá de Henares are approved by the United States FDA and the European health authorities. Our San Sebastián de los Reyes plant is likewise approved by the European health authorities. All three plants have significant production capacities and provide a service based on excellence.
One of the results of our efforts to foster the loyalty of our existing customers and acquire new ones has been that the contract with MSD for formulation and packaging of the medicines Maxalt® and Maxalt-MLT® has been extended until March 2020. Likewise, we began to manufacture Sintrom® for Merus Labs in the third quarter of 2016.