I should like to extend a heartfelt welcome to our web page in which you will be able to extend your knowledge of our Company.
Laboratorios Farmacéuticos ROVI, S.A. is a chemical and pharmaceutical company incorporated in Madrid in 1946 and its activities concentrate on its own pharmaceutical products, manufacturing for third parties and distribution of other products for which it holds a licence from other laboratories (such as Servier, Novartis or Merck), devoting all its efforts to the satisfaction of its internal and external clients for the promotion of health within Society.
Following our global strategy, we at ROVI have made a strong wager in favour of research and development in the knowledge that the present and the future are enshrined here, thus allowing us to offer products that meet the expectations of Regulatory Authorities, Health-Care Professionals and patients.
I would like to thank the Spanish Government and also the Regional Governments of our country, the efforts they do promoting and encouraging innovation, making available important economic resources to the health sector, through the Ministry of Industry, an important driver for competitiveness promotion of industrial strategic sector, in collaboration with the Ministry of Economy and Competitiveness, promoting the R&D investments executed in Centers of Excellence for R&D&i, in the Scientific Technological Parks distributed through Spanish territory, and through the Ministry of Health, Social Policy and Equality, with its determined commitment for the support policies to national pharmaceutical companies, emphasizing the importance of obtaining medicines of therapeutic interest within the Health System, its contribution to R&D&i as well as the support to the internationalization of Spanish economy and the creation of quality employment.
ROVI's success is based on its commitment to research and innovation, creating a dynamic ecosystem, in which stand out potentially valuable R&D projects in terms of incremental innovation, of strategic and collaborative nature with other leading companies of the sector, biotechnology companies, spin-offs Universities and Public Research Centres. ROVI is present with this spirit in the creation of National Strategic Consortia in Technical Research (CENIT), participating since 2006 as a partner in the Research activities of CENIT Nanofarma, CENIT Melius 2007, CENIT CeyeC 2009, and since 2011 as leader of SNC_Integra project, and ADELIS in 2013, in the ambit of the Program FEDER-INNTERCONECTA for Andalucía.
2014 has been a significant year for ROVI, its performance focused in a strong leadership in R&D, the development of a strategic industrialization plan and the internationalization of its products, have been made possible by a team of approximately 1,000 professionals of ROVI that support our growth, with a solid financial position allowing us to be more competitive, and create greater value for shareholders.
At ROVI we believe that is necessary to continue improving and making progress in innovation, so we began a new time with all our enthusiasm in the H2020 Program, intended to fund research projects and initiatives, technological development, demonstration and innovation of clear European added value.
We should like to count on you to continue with this progress, so I invite you to browse through the contents of these pages and get to know us better.
Welcome to ROVI`s on-line area!
ROVI is a Spanish integrated and specialist pharmaceutical company devoted to research, development, manufacturing and marketing of small molecules and biological medical specialities.
The origins of ROVI date back to 1946, when it began its business operations, and since 1951 it has adopted the corporate name of "Laboratorios Farmacéuticos Rovi, S.A."
Prior to 1981, the Company's activity mainly comprised the marketing in Spain of its own products based on heparin, such as sodium heparin, and pharmaceutical specialities from other international companies pursuant to the corresponding licence agreements.
In 1981, ROVI began its research into fractionated derivatives of heparin known as low molecular weight heparins ("LMWH"). These are used prophylactically in the prevention and treatment of venous thromboembolic disease ("VTD").
In the 1990s, as the result of its research activities, ROVI developed a second generation Low Molecular Weight Heparin (LMWH) known as Bemiparin. This is the active substance of its main product, called Hibor®, and is characterized by its versatility. As a result of this, Hibor® has consolidated its position on the market for anti-thrombotic products as the second most sold LMWH in Spain, with a market share of 26% as of September, 2014.
In 1994, ROVI obtained the Good Manufacturing Practices Certificate for its manufacturing and packaging facilities. This allowed the company to begin offering after 1995 high added-value packaging services to leading international pharmaceutical companies, thus maximizing the capacity of its leading-edge manufacturing and packaging facilities. We are specialists in the manufacturing of packaged small-volume parenteral (SVP) solutions, both in pre-filled syringes and vials.
At the end of the 1990s, ROVI started its activities in Portugal with the marketing of contrast media that were already on the market in Spain.
In 2002, the Company started its process of internationalization with the marketing approval of Bemiparin in Central America and in 2003 in various European markets, such as United Kingdom, Ireland, Portugal, Austria, Greece and Italy.
Since then, Bemiparin has extended its international coverage to more than 80 countries. To this end, ROVI has reached distribution agreements with up to 22 international partners in Italy, Central America, Argentina, Eastern Europe and countries in Commonwealth of Independent States, Ireland, Austria, Greece, Asia and North Africa, India, China and Hong Kong, South Africa, etc.
In 2003, ROVI received the Prince Philip Prize for Corporate Excellence in the field of Technological Innovation awarded by the Spanish Ministry of Industry, Trade and Tourism, for its research and development efforts in the field of anti-coagulant and anti-thrombotic drugs derived from heparin and its repercussion on national and international markets.
In 2004, ROVI obtained the classification of "Excellent", the highest distinction awarded each year by the Ministry of Industry for its innovation and contribution to research and development consortia ("R&D") in Spain.
During 2006, the Company began the construction of a Technological Research and Development Centre located in the Health Technology Park in Granada for the manufacture of active substances and to strengthen its R&D activities. This centre started to operate in 2009 and represents ROVI's wager in favor of the expansion of innovative activities.
In 2007, ROVI acquired the Bertex Pharma GMBH company, a German firm specializing in the technology of slow-release injectable micro-particles, in order to complete and increase the potential of its current R&D pipeline. This is a new technology for the administration of pharmaceutical product that allows the slow-acting release of injectable drugs, in order to reduce the number of doses necessary and facilitate therapeutic compliance by patients.
In 2009, ROVI signed a Strategic Pharmaceutical Manufacturing and Marketing Agreement with Merck Sharp & Dhome (MSD) in Spain. Under the agreement, ROVI acquires the manufacturing and packaging operations of the MSD facility in Alcala de Henares, Frosst Ibérica, manufactures and supplies to MSD the products produced at the facility before the acquisition, adds three MSD products to its portfolio (Ameride®, Tryptizol®; and Prinivil® and Prinivil Plus®) and receives distribution rights in Spain to five MSD products through a co-marketing agreement.
In 2010, ROVI
obtained the license to market Thymanax®
from Laboratoires Servier, an innovative antidepressant indicated for adults with major depressive episodes.
In January 2011, ROVI
, the first of the five marketing licenses for its products that Merck Sharp & Dohme (MSD) awarded to ROVI as part of the strategic marketing and manufacturing agreement of 2009.
In September 2012, ROVI
obtained the FDA (Food and Drug Administration in the United States) approval for its injectables plant. Syringes prefilled with Water for Injection (WFI) by ROVI
at its contract manufacturing plant will be able to be commercialized in the United States.
In June 2013, ROVI
and Sanofi reached an agreement for ROVI
to exercise the purchase option held over Rhodogil®
in Spain. Under this agreement, Rhodogil®
is marketed by ROVI
in the national market. In November 2013, ROVI
announced it had signed an agreement with MEDICE Arzneimittel Pütter GmbH & Co. KG ("Medice") to market in Spain Medicebran®
, products indicated for the treatment of ADHD (Attention Deficit Hyperactivity Disorder) in children and teenagers. In addition, in November 2013, ROVI
also announced it had signed an agreement with Novartis Farmacéutica, S.A. for marketing Hirobriz®
(indacaterol maleate) and Ulunar®
(indacaterol maleate and glycopyrronium bromide) in Spain. Both products are inhaled bronchodilators for patients with respiratory difficulties due to a pulmonary disease known as Chronic Obstructive Pulmonary Disease (COPD). ROVI
expects to market Hirobriz®
in the last quarter of 2014.
In 2014, ROVI
requested the marketing authorization of a biosimilar and generic of enoxaparin (a low molecular weight heparin with anti-thrombotic effect) from European and USA authorities. On February 9th, 2015, after the completion of the validation phase, it started the assessment process for Europe to obtain the mentioned marketing authorization.
As part of the clinical development of the novel long-acting injectable Risperidone ISM®
in October 2015, the company announced it has successfully concluded the PRISMA-2 study. The PRISMA-2 is an open-label, parallel phase II clinical trial that has been carried out in four USA centres. The main objective of this trial was to evaluate the safety and pharmacokinetics, as well as to explore the efficacy, of multiple intramuscular doses of Risperidone ISM®
in patients with stable schizophrenia1
. Sixty-seven schizophrenic subjects randomly received four monthly doses of Risperidone ISM®
75mg, injected either in the gluteus or the deltoid muscle, without any supplementation of oral risperidone.
Our Rules and Values
- The company's main asset is all of us.
- We feel change as real development opportunities.
- It is important to feel we are learning something new every day.
- We like to take responsibility from beginning to end.
- We know we have to earn the confidence of patients day by day.
- We take on the concerns of our clients and share in their successes.
- Our diversity in training, experience and viewpoints make us the best.
- We believe in innovative drugs as driving force for ROVI's growth.
- We set strict ethical standards for ourselves and our collaborators.
- Our ultimate success depends on the efforts of all concerned.
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.
In 2001, ROVI obtained the approval to market Bemiparin in the leading European markets through a mutual recognition procedure in the United Kingdom, Italy, Austria, Greece, Ireland and Portugal. The successful conclusion of a second mutual recognition procedure in 8 Eastern European countries, allowed us in 2006 and 2007, to introduce Bemiparin into new markets such as Czech Republic, Hungary, Slovakia, Poland, the Baltic States (Lithuania, Latvia and Estonia), which in 2008 were joined by Ukraine and Bulgaria, and finally Slovenia in 2009.
ROVI has achieved distribution agreements with highly entrepreneurial pharmaceutical companies that are strongly committed to health such as: Menarini in Central America, and via its subsidiary Berlin-Chemie, in Central and Eastern Europe and in CIS countries; Sigma-Tau in Italy; Vianex in Greece; Dem Ilac in Turkey, Hikma in the Middle East and North Africa; Iberma in Morocco; Probiomed in Mexico; Angelini in Romania; Dexa Medica in Indonesia, EMS in Brasil, Hi-Nice in China, Bagó in Bolivia; Biopas in Venezuela, IL-Sung in Korea, Gerot-Lannach in Austria, Litha-Pharmacare in South Africa, Livar in Iran; Haji Medicine in Pakistan; Gobbi Novag in Argentina; and Stada in Thailand, Malasya, Singapur, Philippines and Vietnam.
Between 2010 and 2012, the international expansion was consolidated with the launch of Bemiparin in countries like Russia, Belarus, Moldova, Mexico, Venezuela, Saudi Arabia, Syria, Oman and Iraq, and in 2013 in South Korea and Rumania, as well as in United Arab Emirates and Lebanon.
Finally, Bemiparin is launched in Qatar, Brazil and China during 2015, which will contribute, without a doubt, to impulse the globalization process of our 2nd generation innovative molecule.
Commercial Presence of BEMIPARIN
59 with approved registration y 15 with pending registration
BEMIPARIN Upcoming Releases
United Arab Emirates