- The company's intellectual property ("IP") covers the
formulation and method of use of polihexanide in the treatment of
acanthamoeba keratitis and fungal keratitis
- The patent, already granted in Italy and EurAsian Countries, ensures IP
protection until 2040
- AKANTIOR® will be commercially available in Germany from Oct.
1st
CATANIA, Italy, Sept. 30,
2024 /PRNewswire/ -- SIFI, a leading
international ophthalmic company, announced that is has received a
Notice of Allowance from the European Patent Office
("EPO") for EP4216966. The newly granted patent,
entitled "formulation based on polyhexamethylene biguanide
for use in the treatment of acanthamoeba keratitis
and/or fungal infections" ("Patent"), relates to the novel
formulation of polihexanide in high
concentration, its method of manufacturing and administration
regimen in the treatment of acanthamoeba keratitis
("AK") and fungal keratitis
("FK").
The Patent was already granted in Italy in 2022 (IT102020000027155) and in
Eurasian Countries earlier this year (EA047258). SIFI is seeking
global IP protection through additional patent applications,
including in USA, Canada,
Mexico, South Korea, India, Australia, Japan and China.
The Patent grant follows SIFI's findings in the Phase 3 clinical
trial, where AKANTIOR® (polihexanide 0.08%) demonstrated
an 86% clinical resolution rate in AK, with an average
time-to-cure of approximately 4 months. The Patent also covers the
novel dosing regimen of 16 drops/day for first 5 days, 8 drops/day
for the following 7 days, 6 drops/day for the following 7 days and
4 drops/day until clinical resolution. The proven dosing regimen
represents also a major improvement in patients' quality of life,
as it allows during the initial and most intensive phase of the
treatment daytime-only instillation of a single medicinal product
compared to 24 hourly instillations of up to 3 off-label or
unlicensed drugs used as best supportive care until now.
Following the granting of a marketing authorisation for the
treatment of AK by the European Commission in August, SIFI is
launching AKANTIOR® in Germany,
where the product will be commercially available from Oct. 1st. Additional European markets
will follow based on local early access and reimbursement process
timelines.
"The granting of the European Patent further demonstrates the
innovative profile of our asset for rare corneal infectious
diseases, that are very severe and difficult to resolve." Fabrizio
Chines, Chairman and CEO of SIFI. "The launch of Akantior® in
Germany also marks a significant
milestone in our corporate development, establishing a direct
presence in Europe's largest
pharmaceutical market."
SIFI's polihexanide received two orphan drug designation ("ODD")
from the US Food and Drug Administration for the treatment of
AK and FK, and an additional ODD from the European Medicines
Agency for the treatment of FK.
ABOUT AKANTIOR®: AKANTIOR (polihexanide 0.08%)
is the first approved drug for the treatment of AK 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 (0.08%) concentration which makes it
possible to administer as monotherapy eye drops in single-dose
containers.
ABOUT AK: AK is an ultra-rare, acute, severe parasitic
corneal infection caused by acanthamoeba, a free-living amoeba,
although incidence of AK has been rapidly growing in recent years.
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.
ABOUT SIFI: SIFI is a leading international ophthalmic
company, headquartered in Italy,
featuring an integrated business model, from research &
development to manufacturing and commercialization both in
pharmaceutical and biomedical sectors. Since our foundation in
1935, our mission is to improve people's lives through meaningful
innovation in eye care. SIFI exports to more than 40 Countries
worldwide with a direct presence in major European markets,
Mexico and, through joint
ventures, in China and the United
Arab Emirates. More information available at
www.sifigroup.com
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