SIFI ANNOUNCES LICENSE AGREEMENT WITH AVANZANITE BIOSCIENCE FOR AKANTIOR®

• Collaboration offers potential access to hundreds of patients across several European Countries.
• SIFI will focus its European market access and commercial activities on existing markets, and the new markets Germany and the United Kingdom.
• SIFI expects a potential positive opinion by the Committee for Medicinal Products for Human Use and New Drug Application to the US Food and Drug Administration (FDA) in 2023.

CATANIA, Italy, Jan. 10, 2023 /PRNewswire/ -- SIFI, a leading international ophthalmic company headquartered in Italy, today announced that it has partnered with Avanzanite Bioscience (Avanzanite), a Dutch specialty pharmaceutical company, to exclusively commercialize and distribute AKANTIOR^® (polihexanide) in 26 Countries within the European Economic Area and Switzerland. Under the terms of the agreement, SIFI will handle all ongoing regulatory activities, whilst Avanzanite will focus on market access, distribution and commercial activities in those markets. The partnership will enable commercial access to AKANTIOR^® to an estimated 500 patients who suffer from Acanthamoeba Keratitis (AK) each year in these territories.

SIFI will focus and continue to invest in market access and commercial activities related to AKANTIOR^® on existing and new European Countries, such as Italy, France, Germany, United Kingdom, Spain, Romania and Turkey, whilst continuing to evaluate different options for the commercialization of AKANTIOR^® globally, including potential license agreements outside its core markets.

SIFI and Avanzanite also agreed to expand the Early Access Program (EAP) already in place for the big 5 European Countries to selected Countries within the scope of the license to Avanzanite.

The European Medicines Agency (EMA) validated SIFI's Marketing Authorization Application (MAA) for AKANTIOR^® in May 2022. SIFI expects a potential positive opinion of the EMA Committee for Medicinal Products for Human Use in 2023. Detailed positive results and new data from the completed phase 3 trial were presented at the American Academy of Ophthalmology Annual Meeting in Chicago in October 2022.

Fabrizio Chines, SIFI Chairman and CEO, stated "We made significant investments on AKANTIOR^® throughout 15 years of rigorous research and are looking for ways to maximize our asset's potential. As we advance towards a regulatory approval in dozens of European Countries, we are excited to partner with Avanzanite, as this collaboration promises to accelerate access to our drug candidate to patients in several markets that are outside of our current commercial focus." Mr.  Chines continued, "Avanzanite's management team brings a substantial track record in delivering orphan medicines to niche European markets, which we expect will result in an accelerated return on investment for SIFI."

Avanzanite's Founder and CEO, Adam Plich, stated, "Today's announcement bears all the hallmarks of what we're passionate about: Increasing access to orphan drugs for patients suffering from very rare diseases across Europe and optimizing economic returns for our partners. Plain and simple, through this alliance, Avanzanite is not only contributing to market access to those afflicted by the devastation of AK in European markets previously unapproachable to SIFI but is also unlocking additional revenue potential for the Company."

ABOUT Acanthamoeba Keratitis (AK): AK is a rare, severe, progressive parasitic corneal infection caused by Acanthamoeba, a free-living amoeba. Urgent medical intervention is required to save the patient's sight. The disease has shown resistance, leads to poor vision, blindness, or even eye loss and often requires single or multiple corneal transplant procedures. Patients report unbearable pain and extreme light sensitivity and can rarely work or lead normal lives until symptoms resolve. The incidence of acanthamoeba keratitis has been rapidly growing in recent years and it accounts for 50% of blindness among contact lens users.

ABOUT AKANTIOR^®: AKANTIOR^® (polihexanide) is an investigational anti-amoebic polymer that has been granted Orphan Drug Designation by both the European Medicines Agency ("EMA") and Food and Drug Administration ("FDA") for AK. It acts on both the trophozoites and cysts of the protozoan Acanthamoeba. It is formulated at a unique 0.8mg/ml high dose strength which makes it possible to administer as monotherapy eye drops in single-dose containers. Polihexanide is also being developed by SIFI for the treatment of fungal keratitis for which indication it also has FDA Orphan Drug Designation.

ABOUT SIFI: SIFI is a leading international ophthalmic company, headquartered in Italy, focusing on eye care since 1935. SIFI develops, manufactures, and markets innovative therapeutic solutions for patients with ophthalmic conditions. SIFI is fully committed through its R&D to improving the quality of life of patients, exporting treatments to more than 25 countries worldwide with a direct presence in Italy, Spain, France, Romania, Mexico, and Turkey.

ABOUT AVANZANITE BIOSCIENCE: Avanzanite is a commercial-stage pharmaceutical company, headquartered in the Netherlands, on a mission to redefine the commercialization of orphan medicines to improve patient access across Europe and beyond. Derived from the word 'Tanzanite' – one of the rarest and most underappreciated gemstones on earth – Avanzanite's  economic goal is to offer end-to-end commercialization and distribution partnerships to research-based biopharmaceutical originators to unlock the full value of their orphan medicines in European markets. The Company's humanitarian goal stems from their commitment to enabling access to novel medicines for patients who suffer from orphan diseases regardless of where in Europe they may live.

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SOURCE SIFI S.p.A.