The positive opinion has arrived from the CHMP, the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA), which recommends the approval of the orphan drug Akantior*, the only treatment in the world for the treatment of acanthamoeba keratitis, a rare corneal infection that typically occurs in contact lens wearers, which can lead to blindness, and for which, until now, there has been no approved treatment. The recommendation by the EMA – we read in a note – comes after 15 years of research and development directed by the Italian Sifi alongside 21 Invest, a European investment group founded by Alessandro Benetton with offices in Italy, France and Poland. The extremely painful pathology affects between 1 and 4 patients per million inhabitants. An estimated 500 cases per year on average in Europe. Over 180 patients are already being treated with Akantior* through compassionate use programs in over 12 European countries. The clinical trial has in fact involved numerous European centers including, in Italy, the San Raffaele hospital in Milan, the SS Giovanni e Paolo hospital in Venice.
Founded in 1935, Sifi is a leading international ophthalmic company, headquartered in Catania, Sicily, that develops, manufactures and distributes innovative pharmaceutical products, nutritional supplements, medical devices and intraocular lenses of superior quality for eye care. The company is characterized by an integrated business model, from research and development to production and marketing in both the pharmaceutical and biomedical sectors. Sifi exports to over 40 countries around the world, with a direct presence in the main European markets, in Mexico and, through joint ventures, in China and the United Arab Emirates. Having entered the 21 Invest portfolio in 2015, the company has achieved a turnover of around 100 million euros in 2023, with 65% of revenues coming from abroad and a workforce of around 500 highly qualified employees (63% graduates ). After years characterized by important investments, amounting to tens of millions, in R&D, several new products have recently been launched which have revitalized the market offer and, among these, the orphan drug Akantior*.
“We are very satisfied to have received this positive opinion from the CHMP – states Fabrizio Chines, President and CEO of Sifi – This innovative therapeutic solution will help patients suffering from a very debilitating condition in daily life. We have been innovating in ophthalmology for nearly 90 years, and Akantior* represents a significant milestone, as well as evidence of our commitment to addressing unmet medical needs in our field.”
Alessandro Benetton, president and founder of 21 Invest adds: “Sifi is a jewel of Southern Italy that we have believed in since 2015. We have always been alongside the Chines brothers, providing our constant support. We know that supporting a company in orphan drug research for such a long period goes beyond what is normally required of an investment fund, but these are the actions that distinguish our approach to the growth of companies where let’s invest.”
The next steps towards the approval of the orphan drug include the examination by the European Commission which will decide on the marketing authorization in August 2024. The drug will be marketed directly by Sifi in the main European markets such as France, Germany, Italy, Romania, Spain in addition to the United Kingdom and Turkey. Through distribution agreements Akantior* will also be available in numerous other European countries.
#Ema #treatment #acanthamoeba #rare #infection #lead #blindness
