Italy-based Sifi formed a collaboration with Avanzanite Bioscience, a Dutch specialty pharmaceutical business, to commercialize and distribute Akantior (polihexanide) exclusively in 26 European Economic Area and Swiss countries.
Sifi will manage all ongoing regulatory activities under the terms of the agreement, while Avanzanite will focus on market entry, distribution, and commercial activity in those markets. The collaboration will provide commercial access to Akantior to an estimated 500 patients in these territories who suffer from acanthamoeba keratitis (AK) each year.
Sifi will continue to focus and invest in market access and commercial activities related to Akantior in existing and new European countries such as Italy, France, Germany, the United Kingdom, Spain, Romania, and Turkey, while also evaluating various options for Akantior commercialization globally, including potential license agreements outside of its core markets.
Sifi and Avanzanite also agreed to expand the existing Early Access Program (EAP) for the main five European nations to selected countries within the scope of Avanzanite's license.
In May 2022, the European Medicines Agency (EMA) approved Sifi's Marketing Authorization Application (MAA) for Akantior. Sifi anticipates that the EMA Committee for Medicinal Products for Human Use will provide a favorable opinion in 2023. The completed phase 3 trial's detailed good results and fresh data 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.”
About Acanthamoeba Keratitis
Acanthamoeba Keratitis (AK) is a rare, severe, and progressive parasitic corneal illness caused by the free-living amoeba Acanthamoeba. Immediate medical action is essential to save the patient’s sight. The disease has developed resistance, causes impaired vision, blindness, or perhaps blindness, and frequently necessitates single or repeated corneal transplant treatments.
Patients complain of pain and severe light sensitivity, and they are unable to work or lead normal lives until their symptoms resolve. The prevalence of acanthamoeba keratitis has increased dramatically in recent years, accounting for 50% of contact lens-related blindness.