Polihexanide

Filing of ASMF and MAA sets the stage for a potential approval in Q2 2025 in the UK Type C meeting feedback confirms pre-clinical and clinical data are adequate for an NDA submission and potential approval of AKANTIOR® in the US CATANIA, Italy, Dec. 16, 2024 /PRNewswire/ -- SIFI, a leading international ophthalmic company, announced the accomplishment of a key milestone in the pursuit of regulatory approvals in the United Kingdom ("UK") and regulatory progress for filing in the United States of America ("USA") for AKANTIOR® in the treatment of Acanthamoeba Keratitis ("AK"). In the UK, SIFI submitted a Marketing Authorization Application ("MAA") for AKANTIOR® and an Active Substance Master File ("ASMF") for its proprietary GMP-grade polihexanide to the Medicines and Healthcare products Regulatory Agency ("MHRA"). This submission follows the European Commission's authorization for AKANTIOR as an orphan medicinal product and the confirmation of eligibility for the International Recognition Procedure from the MHRA. SIFI also applied for an Orphan Drug Designation ("ODD"), which will be evaluated during the regulatory procedure, and for a Promising Innovative Medicine Designation. In the USA, SIFI held a Type C meeting with the Food and Drug Administration ("FDA"), according to its regulatory strategy targeting a New Drug Application ("NDA") in the second half of 2025. The outcome of the meeting supports the company's position that its existing data package, both clinical and non-clinical, will be sufficient for the submission of a NDA and the potential approval of AKANTIOR® in the US, currently anticipated in 2026. The FDA granted the ODD for the US patent in 2025 and of the New Chemical Entity status for polihexanide upon approval. "Following the successful pivotal trial, approval and the commercial launch in the European Union, the regulatory submission in the UK and the pre-submission meeting in the USA mark further important milestones in our commitment to making AKANTIOR®, the first and only approved treatment for AK, available to patients globally." said Fabrizio Chines, Chairman and CEO of SIFI. "As the proportion of population wearing contact lenses in the USA is four times higher than in the European Union, we believe our innovative medicine can make an even higher impact on the medical and social needs of patients suffering from this devastating disease." ABOUT AKANTIOR®: AKANTIOR (polihexanide 0.08%) is the first and only approved drug for the treatment of AK in the world. It is an anti-amoebic polymer that acts on both the trophozoites and cysts of the protozoan acanthamoeba. It is formulated at a 0.8mg/ml (0.08%) concentration which makes it possible to administer as monotherapy eye drops in single-dose containers. ABOUT AK: AK is an ultra-rare, acute, severe parasitic corneal infection caused by acanthamoeba, a free-living amoeba, although incidence of AK has been rapidly growing in recent years. AK is an ocular emergency and requires urgent treatment to save the eye. It can lead to poor vision, potential blindness, or even eye loss and often requires single or multiple corneal transplants. It affects people of all ages, most of whom are young or middle-aged soft contact lens wearers. Patients report unbearable pain and extreme light sensitivity and can rarely work or lead normal lives until symptoms resolve. ABOUT SIFI: SIFI is a leading international ophthalmic company, headquartered in Italy, featuring an integrated business model, from research & development to manufacturing and commercialization both in pharmaceutical and biomedical sectors. Since our foundation in 1935, our mission is to improve people's lives through meaningful innovation in eye care. SIFI exports to more than 60 Countries worldwide with a direct presence in major European markets, Mexico and, through joint ventures, in China and the United Arab Emirates. More information available at SOURCE SIFI S.p.A. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

The company's intellectual property ("IP") covers the formulation and method of use of polihexanide in the treatment of acanthamoeba keratitis and fungal keratitis The patent, already granted in Italy and EurAsian Countries, ensures IP protection until 2040 AKANTIOR® will be commercially available in Germany from Oct. 1st CATANIA, Italy, Sept. 30, 2024 /PRNewswire/ -- SIFI, a leading international ophthalmic company, announced that is has received a Notice of Allowance from the European Patent Office ("EPO") for EP4216966. The newly granted patent, entitled "formulation based on polyhexamethylene biguanide for use in the treatment of acanthamoeba keratitis and/or fungal infections" ("Patent"), relates to the novel formulation of polihexanide in high concentration, its method of manufacturing and administration regimen in the treatment of acanthamoeba keratitis ("AK") and fungal keratitis ("FK"). The Patent was already granted in Italy in 2022 (IT102020000027155) and in Eurasian Countries earlier this year (EA047258). SIFI is seeking global IP protection through additional patent applications, including in USA, Canada, Mexico, South Korea, India, Australia, Japan and China. The Patent grant follows SIFI's findings in the Phase 3 clinical trial, where AKANTIOR® (polihexanide 0.08%) demonstrated an 86% clinical resolution rate in AK, with an average time-to-cure of approximately 4 months. The Patent also covers the novel dosing regimen of 16 drops/day for first 5 days, 8 drops/day for the following 7 days, 6 drops/day for the following 7 days and 4 drops/day until clinical resolution. The proven dosing regimen represents also a major improvement in patients' quality of life, as it allows during the initial and most intensive phase of the treatment daytime-only instillation of a single medicinal product compared to 24 hourly instillations of up to 3 off-label or unlicensed drugs used as best supportive care until now. Following the granting of a marketing authorisation for the treatment of AK by the European Commission in August, SIFI is launching AKANTIOR® in Germany, where the product will be commercially available from Oct. 1st. Additional European markets will follow based on local early access and reimbursement process timelines. "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." 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." SIFI's polihexanide received two orphan drug designation ("ODD") from the US Food and Drug Administration for the treatment of AK and FK, and an additional ODD from the European Medicines Agency for the treatment of FK. ABOUT AKANTIOR®: AKANTIOR (polihexanide 0.08%) is the first approved drug for the treatment of AK in the world. It is an anti-amoebic polymer that acts on both the trophozoites and cysts of the protozoan acanthamoeba. It is formulated at a 0.8mg/ml (0.08%) concentration which makes it possible to administer as monotherapy eye drops in single-dose containers. ABOUT AK: AK is an ultra-rare, acute, severe parasitic corneal infection caused by acanthamoeba, a free-living amoeba, although incidence of AK has been rapidly growing in recent years. AK is an ocular emergency and requires urgent treatment to save the eye. It can lead to poor vision, potential blindness, or even eye loss and often requires single or multiple corneal transplants. It affects people of all ages, most of whom are young or middle-aged soft contact lens wearers. Patients report unbearable pain and extreme light sensitivity and can rarely work or lead normal lives until symptoms resolve. ABOUT SIFI: SIFI is a leading international ophthalmic company, headquartered in Italy, featuring an integrated business model, from research & development to manufacturing and commercialization both in pharmaceutical and biomedical sectors. Since our foundation in 1935, our mission is to improve people's lives through meaningful innovation in eye care. SIFI exports to more than 40 Countries worldwide with a direct presence in major European markets, Mexico and, through joint ventures, in China and the United Arab Emirates. More information available at WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED