SIFI ANNOUNCES EMA VALIDATION OF ITS MARKETING AUTHORISATION APPLICATION FOR AKANTIOR® FOR THE TREATMENT OF ACANTHAMOEBA KERATITIS AND THE OPENING OF AN EARLY ACCESS PROGRAM

• AKANTIOR^® is slated to become the first approved orphan medicinal product for acanthamoeba keratitis after more than 15 years of eye disease research conducted by SIFI
• SIFI reaffirms guidance of potential European Commission approval by 2Q23 and market launch immediately thereafter
• SIFI has launched an early access program across European countries in June 2022

CATANIA, Italy, June 7, 2022 /PRNewswire/ -- SIFI S.p.A. ("SIFI" or the "Company"), a leading international ophthalmic company headquartered in Italy, announced today that the European Medicines Agency ("EMA") has validated its Marketing Authorization Application ("MAA") for AKANTIOR^® (polihexanide) for the treatment of acanthamoeba keratitis ("AK").

Fabrizio Chines, Chairman and CEO of SIFI, stated, "Today's announcement marks the culmination of an extensive research effort across the Company to bring forward the first licensed therapy for acanthamoeba keratitis. I would like to take this opportunity to extend my gratitude to our dedicated leadership and their staffs for their fortitude, skill, and execution capabilities to ensure we achieved this historic milestone." Mr. Chines continued, "Once again, SIFI has brought to bear the innovation that has become synonymous with our Company's brand, and, in the case of AKANTIOR^®, is underscored by the product's proprietary formulation, novel dosing regimen and uniqueness as a mono-therapy," concluded Mr. Chines.

Professor John Dart, the pivotal Phase III clinical trial principal investigator and Honorary Clinical Professor at the Institute of Ophthalmology, University College London, stated, "AK is one of the most severe and painful eye infections and also one for which there is no licensed therapy. Most patients require months of treatment and 25% lose useful vision. Our 15 year drug development project culminated in October 2021 with the completion of the Phase III clinical trial which has demonstrated a high medical cure rate. Our findings show that AKANTIOR^® will provide a majority of AK patients the prospect of recovering their vision and quality of life; I hope that this will soon become the standard of care for treatment of this disease," concluded Professor Dart.

Manuela Marrano, SIFI's Executive Director of Market Access and Regulatory Affairs, stated, "Based on our current estimates, we remain confident in our ability to start the commercial launch AKANTIOR^® across Europe, including the United Kingdom (UK), by 2H23, which will include recommendation from the Committee for Medicinal Products for Human Use ("CHMP") and approvals by the European Commission ("EC") and the Medicines and Healthcare Products Regulatory Agency ("MHRA") in the UK."  The EMA has already granted polihexanide Orphan Drug Designation in this disease.

Ms. Marrano continued, "Considering the higher incidence rate of acanthamoeba keratitis infection during warmer months, coupled with the extreme nature of the disease, its outcomes, and lack of approved medications, SIFI is also proactively launching a pan- European early access program to enable access for patients to AKANTIOR^® without delay, to the extent permitted by each countries regulatory requirements." SIFI has partnered with Durbin, a part of Uniphar Group's Product Access Division and a leading specialist in the international distribution of specialized pharmaceuticals, to manage the Polihexanide Access Program. Durbin has extensive global experience providing, high-quality support while adhering to complex local requirements. "We are incredibly pleased to be working in partnership with SIFI on this important access program," said Dan Piggott, Managing Director of Uniphar Group's Product Access Division. "We look forward to helping facilitate broader access to polihexanide for patients with critical unmet medical needs suffering from acanthamoeba keratitis."

Today's announcement follows 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 (ClinicalTrials.gov Identifier: NCT03274895).  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) stands to become the first approved drug for the treatment of acanthamoeba keratitis in the world. It is an anti-amoebic polymer that acts on both the trophozoites and cysts of the protozoan Acanthamoeba. It is formulated at 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 – compounded or imported – alternatives. Polihexanide is also being developed by SIFI for the treatment of fungal keratitis for which indication it also has FDA Orphan Drug Designation.

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, United Kingdom, Romania, Mexico, and Turkey.

About Durbin

Durbin is a specialist pharmaceutical services provider, distributing critical medications to over 160 different countries. A part of Uniphar Group's Product Access Division, Durbin works in partnership with global pharmaceutical and biotech companies to provide Early Access Programs (EAPs), including Named Patient Supply and Cohort Programs. Durbin has over 25 years' experience designing and implementing EAPs and specializes in strategic consultancy, asset specific program design and innovative, customized delivery models.  

Key Contact AKANTIOR^®:
Jelle Kleijn
Global Head of AKANTIOR^®
+31 615643708
jelle.kleijn@sifigroup.com

for Early Access Program, Key Contact:
Vincenzo Papa
Head of Scientific Affairs AKANTIOR^®
+39 3453698813
Vincenzo.papa@sifigroup.com

For Healthcare Professionals within France, Germany, Italy, Spain and UK wishing to access polihexanide:

Contact Durbin EAP team:
Polihexanide@durbinglobal.com
+44 (0)20 8869 6500

For Healthcare professionals outside the Durbin EAP countries please contact the SIFI EAP Key Contact.

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