Partnership offers treatment access to hundreds of patients across several European countries
SIFI has announced that it has linked up with Avanzanite to commercialise and distribute AKANTIOR across 26 countries within the European economic area as well as Switzerland.
The agreement means that SIFI will handle all ongoing regulatory activities, while Avanzanite will concentrate on market access, distribution and commercial activities in those markets. The collaboration will enable commercial access to AKANTIOR to an estimated 500 patients who suffer from Acanthamoeba Keratitis (AK) every year in these territories.
SIFI will also continue to invest in market access activities, connected with AKANTIOR, throughout existing and new European countries, such as Italy, France, Germany, the UK, Spain, Turkey and Romania. It will also evaluate different options for the commercialisation of the therapy, including potential licence agreements.
Meanwhile, the European Medicines Agency (EMA) validated SIFI’s Marketing Authorisation Application for AKANTIOR in May 2022 and SIFI expects a potential positive opinion of the EMA Committee for Medicinal Products for Human Use this year.
Fabrizio Chines, SIFI chairman and chief executive officer, reflected: “We made significant investments on AKANTIOR throughout 15 years of rigorous research and are looking for ways to maximise 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.”
Avanzanite’s founder and chief executive officer, Adam Plich, concluded: “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 optimising economic returns for our partners.
He added: “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.”
SIFI and Avanzanite have also agreed to expand the Early Access Program, already in place for the big five European countries, to selected countries within the scope of the licence to Avanzanite.
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