SIFI and Durbin Announce the Opening of an Early Access Program for Akantior the Treatment of Acanthamoeba Keratitis
- 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
- Durbin has been appointed to design and implement an Early Access Program within Germany, France, Italy, Spain and the UK, and will continue to manage the program until local commercial launch. It is anticipated that patients in the listed countries will be able to access treatment as early as June 2022.
LONDON, UK, June 7th, 2022 – Durbin PLC (“Durbin” or the “Company”), a part of Uniphar Group’s Product Access Division and a leading specialist in the international distribution of specialized pharmaceuticals, and SIFI, a leading international ophthalmic company headquartered in Italy, today announced the opening of an Early Access Program (EAP) supplying Akantior to patients in Germany, France, Italy, Spain and the UK. SIFI have further confirmed that the European Medicines Agency (“EMA”) has validated the Marketing Authorization Application (“MAA”) for AKANTIOR® (polihexanide) for the treatment of acanthamoeba keratitis (“AK”).
Manuela Marrano, SIFI’s Executive Director of Market Access and Regulatory Affairs, stated “SIFI is 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.” The EMA has already granted polihexanide Orphan Drug Designation in this disease.
Dan Piggott, Managing Director of Uniphar Group’s Product Access Division stated “We are incredibly pleased to be working in partnership with SIFI on this important access program. 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. The company 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:
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 at:
Polihexanide@durbinglobal.com
+ 44 (0)20 8869 6500
For Healthcare professionals outside the Durbin EAP countries please contact the Sifi EAP team