Sifi Announces License Agreement with Avanzanite Bioscience for Acanthamoeba Keratitis Treatment Akantior
Italy-based Sifi announced that it has partnered with Avanzanite Bioscience, 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, including 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.
“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,” Fabrizio Chines, Sifi Chairman and CEO, said in a company news release. “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.”
Acanthamoeba Keratitis (AK) isa 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 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.