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- SIFI, a leading international ophthalmic company, has agreed to merge with European pharmaceutical company Faes Farma in a transaction that positions ophthalmology as approximately 20% of the combined entity's pro-forma revenue. - The merger will accelerate development of Akantior (polihexanide 0.08%), the first and only approved therapy worldwide for Acanthamoeba Keratitis, particularly targeting expansion into the US market where it has orphan drug designation. - The combined entity will leverage commercial synergies across complementary markets in Europe and Latin America, while also advancing polihexanide development for additional orphan indications including Fungal Keratitis. - The transaction values SIFI at a double-digit multiple of 2024 EBITDA plus regulatory and commercial milestone-based earn-outs, with closing expected in Q3 2025 subject to regulatory approvals.
- SIFI's AKANTIOR® (polihexanide 0.08%) has received both Marketing Authorization and Promising Innovative Medicine designation from the UK's MHRA, marking it as the first approved treatment for Acanthamoeba keratitis. - The approval confirms AKANTIOR's Orphan Drug Designation and New Active Substance status, recognizing its efficacy against an ultra-rare corneal infection that can lead to blindness if untreated. - Following its European approval in August 2024, this UK authorization represents a significant advancement for patients with this devastating eye infection, with SIFI planning to file for NICE reimbursement by June 2025.
- SIFI's submission of the Active Substance Master File and Marketing Authorization Application for AKANTIOR® in the UK paves the way for potential approval in Q2 2025. - A Type C meeting with the FDA confirms that existing pre-clinical and clinical data are adequate for a New Drug Application submission for AKANTIOR® in the US. - The anticipated approval of AKANTIOR® in the US, is expected in 2026, marking a significant step for treating Acanthamoeba Keratitis, especially among contact lens wearers. - AKANTIOR® (polihexanide 0.08%) is the first and only approved drug for Acanthamoeba Keratitis, an ultra-rare and severe parasitic corneal infection.
- SIFI's patent for polihexanide covers its formulation and use in treating Acanthamoeba keratitis and fungal keratitis, providing IP protection until 2040. - AKANTIOR® (polihexanide 0.08%) demonstrated an 86% clinical resolution rate in Acanthamoeba keratitis in a Phase 3 trial, with a novel dosing regimen. - Following European Commission approval, SIFI is launching AKANTIOR® in Germany, marking its first direct presence in a major European pharmaceutical market. - The FDA and EMA previously granted orphan drug designation to SIFI's polihexanide for treating Acanthamoeba keratitis and fungal keratitis.
