Business Wire

AVANZANITE-BIOSCIENCE

Share
Avanzanite Bioscience Reports AKANTIOR® Received Positive CHMP Opinion and Announces Corporate Expansion Into 26 European Countries

Avanzanite Bioscience B.V. (“Avanzanite” or the “Company”), a commercial-stage specialty pharmaceutical company, solely focused on medicines for rare diseases, announced today that the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) issued a positive opinion recommending Marketing Authorisation of AKANTIOR® (polihexanide) for the treatment of acanthamoeba keratitis (“AK”) in adults and children from 12 years of age.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240602312116/en/

To view this piece of content from mms.businesswire.com, please give your consent at the top of this page.

Adam Plich, Founder & CEO, Avanzanite Bioscience B.V. (Photo: Business Wire)

Today’s announcement follows Avanzanite’s licensing and supply agreement with SIFI, a leading Italian ophthalmic healthcare company, that was announced in January 2023, granting Avanzanite the exclusive rights to commercialize AKANTIOR in 26 countries in the European Economic Area and Switzerland.

Avanzanite’s Founder and CEO, Adam Plich, stated, “Avanzanite is a purpose-driven company whose sole mission is to ensure novel medicines reach patients suffering from rare diseases in every market across Europe and beyond. As such, the CHMP positive opinion takes us one step further in our unwavering pursuit of this important goal. No one facing such a monstrous disease should be left behind.” Mr. Plich added, “Through this strategic partnership, Avanzanite is unlocking access to a potential new treatment for those affected by AK in 26 European countries previously unavailable to SIFI.”

This CHMP opinion represents the culmination of more than 15 years of research by SIFI based on a comprehensive data package demonstrating AKANTIOR’s quality, safety, and efficacy. In March 2024, results of the Orphan Drug for Acanthamoeba Keratitis (ODAK) pivotal 135-patient Phase III study were reported and published in Ophthalmology. The trial showed that 86,7% of patients receiving AKANTIOR were cured with a median time to cure of 4,1 months. Furthermore, 66,7% of patients treated with AKANTIOR achieved full vision restoration and only 7,5% required a cornea transplant.

Following the CHMP’s recommendation to approve AKANTIOR for the treatment of AK, the European Commission (EC) will make its final Marketing Authorisation approval decision within approximately 2 months (currently expected in early August 2024). Meanwhile, AKANTIOR remains available through a pre-authorisation distribution program which, to date, has facilitated treatment access to more than 180 patients across 12 European countries.

Following the successful commercialization of Sibnayal®, AKANTIOR will be the second rare disease medicine commercialized by Avanzanite, expanding the company’s footprint across 26 European countries. In February 2023, Avanzanite announced its exclusive distribution agreement with Paris-based specialty pharmaceutical company Advicenne for Sibnayal, approved in the European Union for the treatment of children and adults with distal renal tubular acidosis (dRTA), a rare genetic or acquired kidney disease. Avanzanite’s dedicated team supplies Sibnayal across 8 countries.

ABOUT AVANZANITE BIOSCIENCE: Founded in 2022, Avanzanite is a privately-funded, commercial-stage, specialty pharmaceutical company solely focused on medicines for rare diseases. At Avanzanite we believe all patients should benefit from novel orphan or niche medicines regardless of where they live. Our vision is that no one is left behind when facing a debilitating rare disease. We also believe the people who have dedicated their careers to the research & development of novel orphan or niche medicines deserve to witness their tremendous efforts impacting patients’ lives – the work of these heroes should not lie in vain. We make this happen by acquiring, licensing, or distributing approved or late-stage medicines for rare diseases and commercializing them even where nobody else will. Headquartered in Amsterdam in the Netherlands, Avanzanite has commercial infrastructure and technical operations across Europe. Please visit www.avanzanite.com for additional information.

ABOUT ACANTHAMOEBA KERATITIS (AK): AK is a rare, severe, and progressive parasitic corneal infection caused by Acanthamoeba, a free-living amoeba. Urgent medical intervention is required as the disease often leads to blindness and eye loss. AK often requires single or multiple corneal transplant procedures with comparably low graft survival rates. Patients report unbearable pain and extreme light sensitivity and can rarely work or lead normal lives until symptoms resolve, leaving patients with trauma for life. While still very rare, the incidence of AK has grown rapidly in recent years. AK primarily affects contact lens wearers, accounting for 50% of blindness among them.

ABOUT AKANTIOR®: AKANTIOR (polihexanide) is an anti-amoebic polymer that has been granted Orphan Drug Designation (ODD) by both the European Medicines Agency ("EMA") and Food and Drug Administration ("FDA") for AK. It acts on both the trophozoites and cysts of the protozoan Acanthamoeba. It is formulated at a unique high 0.8 mg/ml dose strength which makes it possible to administer through a validated and standardized, day-only protocol as monotherapy eye drops in single-dose containers. Polihexanide is also being developed by SIFI for the treatment of fungal keratitis for which indication it also has FDA ODD.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240602312116/en/

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com
DK

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

The Coca-Cola Company Names New Leader for Europe Operating Unit18.7.2025 21:00:00 CEST | Press release

The Coca-Cola Company today announced that Luisa Ortega will become president of the Europe operating unit effective Sept. 1, succeeding Nikos Koumettis, who will retire in 2026 after a 25-year career with the company. Koumettis will remain with the company through Feb. 28, 2026, as a senior advisor. He will also serve on the board of directors of Hindustan Coca-Cola Beverages Pvt. Ltd., a company-owned bottler in India. Ortega joined Coca-Cola in 2019 and currently serves as president of the Africa operating unit. In this role, she leads a complex business that operates across 54 markets. Koumettis has led the Europe operating unit since it was created in 2021. “Luisa has done an outstanding job leading our African business, where our system has continued to make major investments to serve growing markets on the continent,” said Henrique Braun, Executive Vice President and Chief Operating Officer of The Coca-Cola Company. “As head of Europe, she will bring great international experien

NFL Running Back Derrick Henry Joins Amazfit as Athlete Ambassador18.7.2025 15:00:00 CEST | Press release

Henry to utilize Amazfit products to optimize health, recovery and performance as he enters his 10th NFL season Amazfit, a leading global smart wearables brand owned by Zepp Health (NYSE: ZEPP), announced Baltimore Ravens running back Derrick Henry as the newest elite athlete to join its growing roster of ambassadors. Known for his rare combination of speed and strength, Henry will utilize Amazfit wearables to power every phase of his training, recovery and sleep as he prepares for his 10th NFL season. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250718322498/en/ Derrick Henry is the newest elite athlete to join Amazfit's growing roster of ambassadors. As one of the most prolific running backs of his generation, Henry has amassed an impressive array of accolades during his career, including NFL Offensive Player of the Year, two rushing titles, and five Pro Bowl selections. With Amazfit as his official smart wearable partne

Qualcomm Announces Quarterly Cash Dividend18.7.2025 15:00:00 CEST | Press release

Qualcomm Incorporated (NASDAQ: QCOM) today announced a quarterly cash dividend of $0.89 per common share, payable on September 25, 2025, to stockholders of record at the close of business on September 4, 2025. About Qualcomm Qualcomm relentlessly innovates to deliver intelligent computing everywhere, helping the world tackle some of its most important challenges. Building on our 40 years of technology leadership in creating era-defining breakthroughs, we deliver a broad portfolio of solutions built with our leading-edge AI, high-performance, low-power computing, and unrivaled connectivity. Our Snapdragon® platforms power extraordinary consumer experiences, and our Qualcomm Dragonwing™ products empower businesses and industries to scale to new heights. Together with our ecosystem partners, we enable next-generation digital transformation to enrich lives, improve businesses, and advance societies. At Qualcomm, we are engineering human progress. Qualcomm Incorporated includes our licensin

MultiBank Group Confirms $MBG Token Listings on MEXC and Gate.io on TGE Day in Addition to MultiBank.io and Uniswap18.7.2025 14:34:00 CEST | Press release

MultiBank Group, the world’s largest & most regulated financial derivatives institution, is proud to announce that its highly anticipated $MBG Token will be listed on two new major global cryptocurrency exchanges — MEXC and Gate.io — on the day of its official Token Generation Event (TGE), July 22, 2025, in addition to MultiBank.io and Uniswap. The $MBG Token will go live on: MultiBank.ioGate.ioMEXCUniswap This new dual listing will allow millions of users across both exchanges to seamlessly access and trade $MBG using their existing accounts, ensuring immediate market participation at launch. The Token Generation Event (TGE) is now approaching following the successful completion of two pre-sale rounds, where MultiBank Group issued 7 million tokens in Round 1 and 3 million tokens in Round 2 — both of which sold out within minutes. Naser Taher, Chairman and Founder of MultiBank Group said “With $MBG, we’re introducing a utility token built to deliver real-world value, transparency, and

SLB Announces Second-Quarter 2025 Results18.7.2025 12:50:00 CEST | Press release

Revenue of $8.55 billion increased 1% sequentially and decreased 6% year on year GAAP EPS of $0.74 increased 28% sequentially and decreased 4% year on year EPS, excluding charges and credits, of $0.74 increased 3% sequentially and decreased 13% year on year Net income attributable to SLB of $1.01 billion increased 27% sequentially and decreased 9% year on year Adjusted EBITDA of $2.05 billion increased 2% sequentially and decreased 10% year on year Cash flow from operations was $1.14 billion and free cash flow was $622 million Board approved quarterly cash dividend of $0.285 per share SLB (NYSE: SLB) today announced results for the second-quarter 2025. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250716727689/en/ The exterior of the SLB headquarters in Houston, Texas. Second-Quarter Results(Stated in millions, except per share amounts)Three Months EndedChangeJun. 30, 2025Mar. 31, 2025Jun. 30, 2024SequentialYear-on-yearReve

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye