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), 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
ROVI's history is a story of success, a story of growth. The main pillars are:
·Our heparin franchise since the 1950s, with two low-molecular-weight heparins developed in-house: Bemiparin and Biosimilar Enoxaparin.
·Our specialty pharmaceutical business in Spain, where ROVI has an excellent track record with 40 products and one of the largest sales forces (around 250 employees).
·Our ISM® technology, a new patented long-acting injectable technology, aimed at replacing the daily administration of drugs with a monthly or quarterly injection in patients undergoing long-term treatments for certain chronic conditions.
·Our Contract Development and Manufacturing Organization (CDMO) business, where ROVI is one of the world leaders in the manufacturing of pre-filled syringes.
Specialty Pharmaceutical Business
Within the pharmaceutical specialties business, the main catalysts are the heparin division (low-molecular-weight heparins and other heparins), Risperidone ISM®, distribution licensing agreements in Spain (Neparvis®, Orvatez®, etc.) and potential new product licenses to third parties.
ROVI aspires to become a global leader in the field of low-molecular-weight heparins (LMWH). The Group is present both in Spain, where it conducts the majority of its marketing operations, as well as all of its manufacturing services and research and development activities, and internationally, with subsidiaries in France, Portugal, Germany, Italy, the United Kingdom, and Poland, through which it markets its products.
Bemiparin, one of its most widely-distributed products, is available in 64 countries.
Additionally, ROVI has strengthened its international presence through the commercialization of its enoxaparin biosimilar since 2017. At the end of 2023, ROVI’s enoxaparin biosimilar had been approved in 26 countries in Europe, as well as 33 in the rest of the world, with presence in 40 countries through different distribution agreements.
Currently, ROVI has a portfolio of over 40 products, grouped into nine different pharmaceutical areas. The portfolio includes both ROVI’s own and licensed products and there is growing demand for most of them. They are virtually unaffected by the reference pricing system in Spain.
ROVI has launched 15 new products in the market in the last 13 years.
R&D
Our success is based on the constant effort we put into R&D.
ROVI operates with a low-risk strategy, focusing on chronic diseases with broad medical needs.
The ISM® technology, a long-acting technology, is currently exclusive to ROVI and is patent protected until 2033. Intended to overcome most of the disadvantages of prolonged-release oral or parenteral formulations, it has advantages such as simpler administration, higher encapsulation efficiency, greater stability of the active substance, greater control in the initial release of the drug, reduction in treatment frequency, etc.
Since 2022, ROVI has been marketing in Europe its first product based on its leading-edge drug-delivery technology, Risperidone ISM®, for the treatment of schizophrenia in adults. In 2022, this product was launched in Germany, the United Kingdom and Spain and, in 2023, in Portugal, Italy, Austria, Greece and Serbia. Also, in the first half of 2024, the product was approved in the United States, Canada and Australia.
Additionally, the group continues working on its ISM® platform with the development of Phase I of Letrozole LEBE, a clinical trial applying the ISM® technology in a quarterly formulation of an aromatase inhibitor for breast cancer treatment, and with the development of Phase I of quarterly risperidone for the maintenance treatment of clinically stable schizophrenia patients.
CDMO
In the recent years, ROVI has significantly expanded its production capacity as part of its commitment to strengthening its contract manufacturing division. This expansion includes the acquisition of new clients to maximize the potential of both our two injectables plants and the solid oral forms plant.
Our three plants are approved by the United States FDA and the European health authorities. All three plants have significant production capacities and provide a service based on excellence.