SIFI PROVIDES REGULATORY UPDATES FOR AKANTIOR® (POLIHEXANIDE 0.8 MG/ML) IN EUROPE AND THE UNITED STATES

• European Medicines Agency: Received AKANTIOR^® Trade Name approval; Conducted favourable pre-Marketing Authorisation Applications meetings with designated Rapporteurs; Reiterated original guidance to submit MAA in Q2 2022.
• Food and Drug Administration: Requested Type B meeting, slated to take place in April 2022.

CATANIA, Italy, Feb 15, 2022  – SIFI S.p.A. (“SIFI” or the “Company”), a leading international ophthalmic company headquartered in Italy, announced today the accomplishment of several targets concerning the regulatory procedure of polihexanide 0.8 mg/ml for the treatment of acanthamoeba keratitis.

The Name Review Group of the European Medicines Agency (“EMA”) has approved AKANTIOR^® as the trade name for the drug candidate. “We selected AKANTIOR^® as a brand name as it radiates the strength patients with acanthamoeba keratitis urgently need when fighting this sight-threatening parasitic eye infection,” explained Jelle Kleijn, SIFI’s Global Head of AKANTIOR^®.

Following the Company’s announcement in October 2021 that the pivotal Phase III trial of AKANTIOR^® in adults and adolescents with acanthamoeba keratitis met its primary endpoint, SIFI held meetings with the EMA designated Rapporteurs late in 2021 to discuss the timelines and process of its potential regulatory approval.

Based on the Rapporteurs’ positive feedback and the strength of the trial results, the Company remains confident in its original guidance to submit the Marketing Authorisation Application (“MAA”) with the EMA in the second quarter of 2022.  The Company will seek regulatory approval under the ‘centralised authorisation procedure’ pathway given polihexanide’s designation as an orphan drug.

“The progress we’ve made in the regulatory approval process since the positive results of the pivotal Phase III trial reflects our commitment to bringing AKANTIOR^® to patients with acanthamoeba keratitis as soon as possible,” stated Manuela Marrano, SIFI’s Executive Director of Market Access and Regulatory Affairs.

With regard to the United States of America, SIFI submitted a request for a ‘Type B’ meeting with the Food and Drug Administration (“FDA”), which is expected to take place in April 2022.

“I’m very proud of the diligence and passionate dedication of our team, as evidenced by the recent and meaningful accomplishments in Europe and USA,” stated Fabrizio Chines, Chairman and CEO of SIFI.  “Considering that no licensed medicine currently exists for this life-altering disease, we believe there is a significant unmet need to provide an effective cure to patients. We look forward to working side-by-side with the most important regulatory agencies globally for an efficient and timely approval of AKANTIOR^®.”

SIFI is evaluating different options for the commercialization of AKANTIOR^® globally, including potential out-licensing agreements for regions beyond its core markets.

ABOUT AKANTIOR^®: AKANTIOR^® (polihexanide 0.8 mg/ml) stands to become the first approved drug for the treatment of acanthamoeba keratitis in the world. It is an anti-infective polymer that acts on both the trophozoites and cysts of the protozoan Acanthamoeba. It is formulated as a 0.8mg/ml concentration which makes it possible to administer as monotherapy eye drops in single-dose containers. In contrast, current treatment protocols include various non-standardized combination therapies involving unlicensed and compounded alternatives.

ABOUT Phase III trial: The trial was a randomized, assessor-masked, active-controlled, multi-center trial of 135 patients designed to evaluate the efficacy, safety, and tolerability of polihexanide 0.8mg/ml monotherapy compared to a combination of polihexanide 0.2mg/ml + propamidine 1mg/ml. Both treatment arms have used a novel standardized, proprietary treatment protocol (ClinicalTrials.gov Identifier: NCT03274895). It is the first Phase III trial of this size for an investigational medicine performed for acanthamoeba keratitis.

ABOUT Acanthamoeba Keratitis (AK): AK is a rare, acute, severe parasitic corneal infection caused by Acanthamoeba, a free-living amoeba. AK is an ocular emergency and requires urgent treatment to save the eye. It can lead to poor vision, potential blindness, or even eye loss and often requires single or multiple corneal transplants. It affects people of all ages, most of whom are young or middle-aged soft contact lens wearers. Patients report unbearable pain and extreme light sensitivity and can rarely work or lead normal lives until symptoms resolve. The incidence of AK has been rapidly growing in recent years.

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 20 countries worldwide with a direct presence in Italy, Spain, France, Romania, Mexico, and Turkey.

Key Contact:

Jelle Kleijn

Global Head of AKANTIOR^®

+31 615643708

jelle.kleijn@sifigroup.com