Acanthamoeba Keratitis

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 WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

An ultra-rare, sight-threatening corneal infection, acanthamoeba keratitis causes intense pain and photophobia. Credit: Jo Panuwat D/Shutterstock. Italian ophthalmic company SIFI has received European Commission (EC) approval for AKANTIOR (polihexanide) to treat acanthamoeba keratitis (AK), a rare and severe corneal infection. The asset is the first therapy approved for AK in Europe. AKANTIOR targets both adults and children aged 12 years and above. Its commercial launch is set to begin in Germany in the fourth quarter of 2024, with subsequent rollouts in France, Italy, Romania, Spain, Türkiye and the UK. The launches are contingent on each country’s regulatory and reimbursement processes. See Also: AstraZeneca may pull plug on UK vaccine manufacturing plans Touchlight to supply GMP dbDNA for UK Zika vaccine study SIFI has also partnered with Avanzanite to introduce AKANTIOR in other European markets. AKANTIOR (polihexanide 0.08%) is an anti-amoebic polymer effective against both the trophozoites and cysts stages of acanthamoeba. It can be used as a monotherapy in the form of single-dose eye drops. The US Food and Drug Administration (FDA) granted orphan drug designation for AKANTIOR. An ultra-rare, sight-threatening corneal infection, AK causes intense pain and photophobia. The infection primarily affects those who wear contact lenses and is caused by the acanthamoeba protozoan. SIFI chairman and CEO Fabrizio Chines stated: “The approval represents an important step towards delivering a new global standard of care for patients with AK and builds on 15 years of research and development. “For the first time in Europe, AK patients have an approved therapy, marking a new era in the treatment of this disease, which may lead to blindness. AKANTIOR is the first and only approved medicine for AK, and our team is committed to developing polihexanide in other corneal infectious diseases, such as fungal keratitis, where we obtained orphan drug designation from the European Medicines Agency and the FDA.”

Regeneron has won approval in Europe for its blood cancer T-cell engager odronextamab five months after the FDA rejected the treatment under its accelerated pathway because of the timeline of its confirmatory trial. Five months after the FDA rejected Regeneron’s bid for accelerated approval of its T-cell engager odronextamab because of the immaturity of its confirmatory trial, the European Union has signed off on the treatment for two types of blood cancers.In winning the nod from the European Commission for relapsed or refractory follicular lymphoma (FL) and for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), Ordspono becomes Regeneron’s first approved bispecific antibody. The endorsement covers patients who have undergone two or more lines of systemic therapy.Separately, the EC also granted a first-time approval to SIFI’s Akantior (polyhexanide), which becomes the first therapy to treat the rare corneal infection acanthamoeba keratitis. The sudden, parasitic disorder can cause blindness and primarily affects those who wear soft contact lenses. The Italian company has received orphan drug designation from the FDA for polyhexanide as a potential treatment for both acanthamoeba keratitis and fungal keratitis. Regeneron’s approval was backed by phase 1 and phase 2 trials that provided remarkable data. In the ELM-2 study, patients with FL showed an 80% overall response rate (ORR), with 73% achieving a complete response (CR). The median duration of response (DoR) for the complete responders was 25 months.In the same study, patients with DLBCL who were CAR-T therapy-naïve had a 52% ORR, with 31% reaching CR and having an 18-month median DoR.Despite the results, the FDA sent Regeneron two complete response letters in March, rejecting the company’s application for accelerated approval because its confirmatory trials for odronextamab were not yet underway. The FDA and Regeneron need to agree to timelines of the trials “prior to resubmission,” the company said.The rejection came as the FDA is wrestling with how to adjudicate accelerated approvals. With the recent failures of some FDA-sanctioned drugs, the approval mechanism has come under scrutiny. A recent study published in the Journal of the American Medical Association showed that 80% of drugs approved under the pathway couldn't demonstrate survival benefits after five years.In April, the FDA's Oncology Center of Excellence chief Richard Pazdur, M.D., addressed the issue.“If we really believe that there are no other therapeutic alternatives, then there will be obviously some degree of flexibility,” Pazdur said. “When we do see, however, that there may be accelerated approval with the same class of drugs with the same diseases and with sponsors previously having most of the confirmatory study accrual already completed at the time of accelerated approval, we have to have a level playing field for all of the pharmaceutical companies.” In the case of odronextamab, there are other new treatments from its drug class on the market in the indications. Over the last 15 months, AbbVie and Genmab’s bispecific antibody Epkinly has gained FDA nods for both FL and DLBCL. Meanwhile, Roche has two T-cell engagers on the market: Columvi earned an FDA nod in DLBCL in June, and Lunsumino was approved by the FDA as a treatment for FL in December of 2022.All the endorsements for the therapies have been for third-line use. In clinical trials, each of the companies, including Regeneron, is combining the T-cell engagers with other medicines in attempt to move them into earlier treatment lines.“Ordspono marks the first approval from our bispecific antibody platform, which we hope will increasingly contribute to our growing portfolio of practice-changing medicines for oncology and other diseases,” George Yancopoulos, M.D., Ph.D., Regeneron’s chief scientific officer, said in a release.