Polihexanide

The transaction will enable strong commercial synergies, thanks to Faes Farma's presence in complementary markets and recent acquisition of Laboratorios Edol It enables funding further development of SIFI's portfolio, most notably Akantior in the USA SIFI's existing infrastructure, including its Aci S. Antonio facilities, will further expand under the combined entity CATANIA, Italy, June 10, 2025 /PRNewswire/ -- SIFI, a leading international ophthalmic company, today announced that its shareholders have signed an agreement, subject to conditions precedent, to sell 100% of SIFI shares to Faes Farma, a leading European pharmaceutical company listed on the Spanish stock exchange. The transaction validates SIFI's unique business model centred around the consolidated pharmaceutical and surgical units, combined with the fast-growing contract manufacturing and rare diseases units. SIFI will enable Faes Farma to offer one of the most comprehensive ophthalmology portfolios in the industry, with a complementary geographic presence. The integration of SIFI and Laboratorios Edol, a leading Portuguese pharmaceutical recently acquired by Faes Farma, positions ophthalmology as a pivotal area for the combined entity (the "Group"), representing approximately 20% of its pro-forma revenue, and allows for further portfolio synergies. SIFI facilitates the Group's entry into new high-growth regions in Europe, such as Italy, France, Romania, and Turkey, while bolstering the Group's presence in others, such as Iberia, Mexico and Latin America. Furthermore, product integration should unlock cross-selling opportunities, improving growth and margins through operational and cost efficiencies. The Group will invest into the further development of Akantior (polihexanide 0.08%) into existing and new geographies, most notably in the USA, as well as the development of polihexanide into additional orphan indications. Akantior is approved by the European Medicines Agency (EMA) and United Kingdom's Medicines & Healthcare products Regulatory Agency (MHRA) for the treatment of Acanthamoeba Keratitis (AK) in adults and children aged 12 and older. Akantior is the first and only approved therapy for AK anywhere in the world, addressing an ultra-rare, severe, and progressive corneal infection affecting approximately 3,000 patients annually in Europe and the United States. Launched in Germany in October 2024, pricing and reimbursement procedures are underway in other European countries. It is also in the pre-registration phase with the FDA (U.S. Food and Drug Administration) with orphan drug designation. Polihexanide will soon begin clinical development for Fungal Keratitis, after promising preclinical data and the granting of orphan drug designation in Europe and US. SIFI will continue to operate its two state-of-the-art plants in Aci S. Antonio, focused on the production of ophthalmic medications and intraocular lenses, leveraging on recently secured long-term contract manufacturing agreements, with significant recurring revenue potential. Additionally, SIFI's facilities will optimize the Group's industrial capabilities, enhancing operational efficiency. "Faes Farma shares similar values, culture and is highly complementary to our organization, which is set to become the pillar of the enlarged group's ambitious strategy in ophthalmology, a therapeutic area where the SIFI brand is synonymous with quality, innovation and long-term commitment. This transaction represents a key milestone for our company and will accelerate growth, unlock synergies, and enhance long-term value for all stakeholders, first and foremost by expanding global access to the medicines and devices we provide for ophthalmic patients.", stated Fabrizio Chines, CEO of SIFI. "We are impressed with the strength of SIFI's business model and the capabilities of its management team. This transaction strengthens our position in ophthalmology, a therapeutic area with significant growth potential, and accelerates our international expansion with direct access to new markets in Europe. We look forward to working with Fabrizio Chines and SIFI's management team to fulfill our commitment to an innovative and more global ophthalmic franchise, offering a broader range of solutions aligned with the needs of professionals and patients and our common ambitions.", stated Eduardo Recoder de la Cuadra, CEO of Faes Farma. The transaction values SIFI at an upfront Enterprise Value equal to a double-digit multiple of 2024 EBITDA, plus earn-outs linked to certain regulatory and commercial milestones related to Akantior. The transaction is expected to close in the third quarter of 2025, subject to customary approval by competition and foreign investment authorities and the extraordinary shareholders' meeting of Faes Farma, which is expected during July 2025. Evercore Partners International LLP ("Evercore") and Mediobanca - Banca di Credito Finanziario S.p.A. ("Mediobanca") are acting as exclusive financial advisor to SIFI's shareholders (founding families and 21 Invest SGR S.p.A. on behalf of managed fund 21 Investimenti III ("21 Invest")). Hogan Lovells Studio Legale ("Hogan Lovells") is acting as legal advisor. J.P. Morgan SE ("JPM") is acting as Faes Farma's exclusive financial advisor and debt financing provider in connection with the transaction. Cuatrecasas Legal SLP ("Cuatrecasas") and Chiomenti Studio Legale ("Chiomenti") serve as legal advisor and Ernst & Young Servicios Corporativos S.L. ("EY"), Gide Loyrette Nouel ("Gide"), Wolf Theiss Rechtsanwälte GmbH & Co KG ("Wolf Theiss") and A.T. Kearney as due diligence providers for Faes Farma. About SIFI SIFI is a leading international ophthalmic company headquartered in Italy, featuring an integrated business model from research and development to manufacturing and commercialization in both pharmaceutical and biomedical sectors. Founded in 1935, SIFI's mission is to improve people's lives through meaningful innovation in eye care. The company 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. For more information, visit About Faes Farma Faes Farma is a company with more than 90 years of experience and a presence in more than 130 countries through marketed or licensed products. Faes combine passion, science, and innovation to transform people's health. Faes research, produce, and market prescription drugs, healthcare products, and animal nutrition products, and we aspire to become a leading pharmaceutical group in excellence and innovation. At Faes Farma, people are guided by our values: offering top-quality solutions for health and well-being, with the patient as our priority; developing innovative products that adapt to society's needs; and ensuring integrity, transparency, and commitment through responsible management and excellence. For more information, visit WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

MHRA granted on 6th May the Promising Innovative Medicine (PIM) Designation MHRA granted on 15th May the Marketing Authorisation, confirming the Orphan Drug Designation and the New Active Substance status CATANIA, Italy, May 19, 2025 /PRNewswire/ -- SIFI, a leading international ophthalmic company, today announced that the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has granted the Marketing Authorization for AKANTIOR® (polihexanide 0.08%) confirming the Orphan Drug Designation of the product in the treatment of Acanthamoeba keratitis in adults and children from 12 years of age. The Marketing Authorisation confirms the New Active Substance status, recognizing the investments made by SIFI in developing polihexanide as an active pharmaceutical ingredient according to good manufacturing practices, a key element in ensuring the level of efficacy and safety seen in the ODAK trial and real world evidence. A few days before, the MHRA also awarded AKANTIOR the Promising Innovative Medicine (PIM) designation, confirming that AKANTIOR® meets all three of the following criteria established by the MHRA: The condition is life-threatening or seriously debilitating with special emphasis on patient quality of life, and there is high unmet need as there is no method of treatment available or existing methods have serious limitations. The medicinal product is likely to offer a major advantage over current methods used in the UK. The benefits of the medicinal products are likely to outweigh potential adverse effects. AKANTIOR® becomes the first and only approved treatment for Acanthamoeba keratitis in the United Kingdom, representing a transformative step for UK patients affected by Acanthamoeba keratitis, an ultra-rare and devastating eye infection that can lead to blindness if left untreated. Following the Marketing Authorization in the European Economic Area granted in August 2024, MHRA approval expands the availability into another major European market of AKANTIOR®. SIFI is currently engaged with the National Institute of Clinical Excellence (NICE) and expects to file a full reimbursement dossier by end of June 2025. "Granting Marketing Authorization for AKANTIOR® and its recognition with the Positive PIM designation marks important progress in our mission to provide Acanthamoeba keratitis patients in the UK with access to this innovative treatment," said Manuela Marrano, Executive Director, Regulatory and Market Access, SIFI "This recognition by the MHRA underscores the potential of AKANTIOR® to address this high unmet medical need, confirming AKANTIOR® has significant benefits for patients with severely debilitating conditions. We also look forward to continuing our interaction with NICE to ensure the widest access in the Country for AKANTIOR." AKANTIOR® (polihexanide 0.08%) is the first and only approved drug specifically developed for the treatment of Acanthamoeba keratitis in the world. It contains an anti-amoebic polymer that acts on both the trophozoite and cyst forms of the protozoan acanthamoeba. AKANTIOR® is formulated as eye drops in single-dose containers at a 0.08% concentration and it is effective as monotherapy. Acanthamoeba keratitis is an ultra-rare, severe, and progressive corneal infection characterized by intense pain and photophobia. It primarily affects contact lens wearers and, if left untreated, can lead to poor vision, blindness, or even loss of the eye. The condition often requires one or multiple corneal transplants. About SIFI SIFI is a leading international ophthalmic company headquartered in Italy, featuring an integrated business model from research and development to manufacturing and commercialization in both pharmaceutical and biomedical sectors. Founded in 1935, SIFI's mission is to improve people's lives through meaningful innovation in eye care. The company 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. For more information, visit WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED