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SIFI receives a positive opinion from the EMA for orphan drug AKANTIOR®

The positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use has arrived, recommending approval of the orphan drug AKANTIOR®, the world’s only treatment for acanthamoeba keratitis, a severely debilitating rare eye disease. This recommendation follows 15 years of research and development led by SIFI, with 21 Invest supporting the effort. Since 2015, millions of euros have been invested in the project.

Treviso, May 31, 2024 - 21 Invest, the European investment group founded by Alessandro Benetton with offices in Italy, France, and Poland, announces that its portfolio company SIFI has received a positive opinion from the CHMP, the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA), with a recommendation to approve the orphan drug AKANTIOR® for the treatment of acanthamoeba keratitis, a rare corneal infection that typically occurs in contact lens wearers and can lead to blindness. This extremely painful condition affects between 1 to 4 patients per million inhabitants and has an average of 500 cases per year in Europe, for which there has been no approved treatment until now. Over 180 patients are already being treated with AKANTIOR® through compassionate use programs in more than 12 European countries. Numerous European facilities were involved in the clinical trials, including San Raffaele Hospital in Milan and SS Giovanni e Paolo Hospital in Venice, Italy.

Founded in 1935, SIFI is a leading international ophthalmic company, headquartered in Catania, Italy. SIFI develops, manufactures, and distributes innovative pharmaceuticals, dietary supplements, medical devices, and high-quality intraocular lenses for eye care. The company operates with an integrated business model, encompassing research and development, production, and marketing in both the pharmaceutical and biomedical sectors. SIFI exports to over 40 countries worldwide, with a direct presence in key European markets, Mexico, and, through joint ventures, in China and the United Arab Emirates.

Since entering 21 Invest's portfolio in 2015, SIFI has achieved a turnover of 100 million euros in 2023, with 65% of turnover generated from international markets and a workforce of approximately 500 highly qualified employees (63% of whom hold degrees).

After years marked by significant investments, in R&D amounting to tens of millions of Euros, several new products have recently been launched, revitalizing the market offering provided by SIFI, including the orphan drug AKANTIOR®.

The next steps toward the approval of the orphan drug include evaluation by the European Commission, which is expected to make a decision about AKANTIOR®'s market authorization in August 2024. The drug will be marketed directly by SIFI in key 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.

Alessandro Benetton, Chairman and Founder of 21 Invest, comments: “SIFI is a Southern Italian treasure that we have believed in since 2015. We have always stood by the Chines brothers, providing our constant support. We know that backing a company in the search for an orphan drug for such a long period goes beyond what is typically required of an investment fund, but these are the actions that distinguish our approach to the growth of our investee companies.

Fabrizio Chines, Chairman and CEO of SIFI, comments: “We are very pleased to have received this positive opinion from the CHMP for AKANTIOR®. This innovative therapeutic solution will help patients suffering from a very debilitating condition in their daily lives. We have been innovating in ophthalmology for nearly 90 years, and AKANTIOR® represents a significant milestone, as well as proof of our commitment to meeting the unmet medical needs in our field.

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