SIFI has announced the allowance of a European patent for its polihexanide formulation and the commercial launch of AKANTIOR® in Germany, marking a significant advancement in the treatment of rare corneal infections. The European Patent Office has granted patent EP4216966, which protects the formulation and method of use of polihexanide in treating Acanthamoeba keratitis (AK) and fungal keratitis (FK). This patent, already granted in Italy and Eurasian countries, provides intellectual property protection until 2040.
Clinical Efficacy and Novel Dosing Regimen
AKANTIOR® (polihexanide 0.08%) demonstrated an 86% clinical resolution rate in AK in a Phase 3 clinical trial, with an average time-to-cure of approximately 4 months. The patent also covers a novel dosing regimen: 16 drops/day for the first 5 days, 8 drops/day for the following 7 days, 6 drops/day for the subsequent 7 days, and 4 drops/day until clinical resolution. This regimen improves patients' quality of life by allowing daytime-only instillation of a single medicinal product, compared to the previous standard of 24-hourly instillations of multiple off-label drugs.
Commercial Launch in Germany
Following the European Commission's marketing authorization in August, SIFI is launching AKANTIOR® in Germany, with commercial availability starting October 1st. Additional European markets will follow, based on local early access and reimbursement timelines.
Executive Commentary
"The granting of the European Patent further demonstrates the innovative profile of our asset for rare corneal infectious diseases, that are very severe and difficult to resolve," said Fabrizio Chines, Chairman and CEO of SIFI. "The launch of Akantior® in Germany also marks a significant milestone in our corporate development, establishing a direct presence in Europe's largest pharmaceutical market."
Orphan Drug Designations
SIFI's polihexanide has received orphan drug designation from the US Food and Drug Administration (FDA) for the treatment of AK and FK, and from the European Medicines Agency (EMA) for the treatment of FK.
About AKANTIOR®
AKANTIOR® (polihexanide 0.08%) is the first approved drug worldwide for treating AK. It is an anti-amoebic polymer effective against both trophozoites and cysts of Acanthamoeba. The 0.08% concentration allows for monotherapy administration as eye drops in single-dose containers.
About Acanthamoeba Keratitis (AK)
AK is a rare, acute, and severe parasitic corneal infection caused by Acanthamoeba. The incidence of AK has been increasing. It can lead to vision impairment, blindness, or eye loss, often requiring corneal transplants. AK affects individuals of all ages, particularly young and middle-aged soft contact lens wearers. Patients experience intense pain and light sensitivity, which can significantly disrupt their daily lives until symptoms resolve.
