The pharmaceutical companies Reig Jofre and Ojer Pharma have recently received marketing authorization from the Portuguese Medicines Agency (Infarmed) for ImpetineⓇ Gel, an innovative mupirocin antibiotic in the form of a transparent and filmogenic bioadhesive gel indicated for the treatment of primary dermatological infections such as impetigo, folliculitis and furunculosis, and secondary infections such as superinfected dermatoses of the skin.

Ojer Pharma is a spin-off pharmaceutical company of the University of Navarra established in 2005 by Carlos González Ojer, former student of the UniversityMaster's Degree in research, development and Drug Innovation (MIDI) of the School of Pharmacy and Nutrition, where he is currently professor of business plan and tutor of Final Projects Master's Degree. The company was set up under the auspices of the research center in Applied Pharmacobiology (CIFA) and the University Foundation of Navarra (FUNA), and, in fact, the preclinical phase of this novel drug has been carried out at the laboratory of Toxicology. It is currently directing all its efforts to develop products and vehicle technologies that address dermatological pathologies (human and veterinary) from a multifunctional perspective (causes and symptoms) and that optimize the safety and efficacy profiles of conventional dermatological treatments. Laboratorios Ojer Pharma has been qualified as Innovative SMEs by the European Medicines Agency (EMA) and is a member of the prestigious association Medicines for Europe where it is part of the value-added medicines section who in 2018 awarded it the award for the most innovative product of the year for the development of another of its medicines (KeramodⓇ Gel).

"This is a case of how entrepreneurship carried out by the University and the talent of the students who graduate, specialize and receive their doctorate at School allow the development of business projects that generate patentable innovations and new treatments that are authorized and recognized internationally," says Carlos Gonzalez.

ImpetineⓇ is a clear example of how incremental innovation provides a added value to patients, healthcare professionals and the national healthcare system by offering better antibiotic treatment with improved posology and formulation that facilitates better adherence to treatment and thereby contributes to the correct use of antibiotics.

It is a product developed in partnership with several centers of research and development and Spanish Universities, patented in the main international markets, and which has successfully passed the preclinical and clinical phases of development . It has been able to demonstrate an optimized efficacy and safety profile with respect to the product of reference letter, making it the first topical antibiotic mupirocin on the market, conveyed in an innovative transparent and bioadhesive gel in the form of a sustained release matrix.

"This important technical milestone achieved only validates the development strategy carried out for the product, which will allow us to extend the authorization to other countries of interest and to respond to the licence marketing agreements already reached," explains González.

International expansion for a global need

According to the medical association Infectious Diseases Society of America (IDSA) the prevalence of this subject of dermatological infections ranges between 7% and 15% of the world population (between 500 and 1 billion cases/year), one of the most prevalent. Specifically, impetigo, highly prevalent in children, reaches 200 million cases per year worldwide; a prevalence average of 14.5% in Europe, with Italy and Greece leading the way, while Spain is in the middle range with a prevalence of 17.5% and a record of around 8 million cases per year.

In parallel to this first process, procedure has started the authorization process in the rest of the European Union countries as well as in Mexico and Canada. The marketing of ImpetineⓇ Gel is expected to begin in the first quarter of 2020 in Portugal and throughout 2021 in Spain, Italy, Greece, Hungary, Canada and Mexico. By 2025, Impetine is expected to be the most prescribed topical antibiotic in Spain with more than 2 million units sold.