Uniphar’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.
Uniphar Access
Uniphar’s access team prides itself on being experts in optimizing access, transforming lives and accelerating product development. We harness the capabilities, infrastructure and experience of Uniphar’s diversified pharmaceutical services, leveraging more than 55 years of building success with 200+ multinational clients.
Our highly experienced team deliver best-in-class access programs with a personal touch and true passion for patient outcomes. We leverage our extensive therapy area experience, local and global launch expertise to deliver pre-approval product access, while providing medical affairs strategies tailored to your market. Our commercial team launch assets, fully commercialize in-licensed therapies and manage established brands using innovative digital and in-person solutions to deliver success.
As part of Uniphar’s Pharma division, access, medical and commercial work together to unlock access to innovative therapies and optimize value while improving patient outcomes around the world.
We provide tailored specialist services and solutions for our clients’ changing needs throughout every stage of the product lifecycle. A publicly traded company with €2b revenue, 3,500 employees and active in more than 160 countries, Uniphar is dedicated to improving patient access to medicines worldwide.
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.
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 Uniphar EAP team:
info-acccess@uniphar.com
+ 44 (0)20 8869 6500