ALT-L9 (aflibercept biosimilar) / Alteogen - LARVOL DELTA

Celltrion and Samsung Bioepis halt the launch of Ilia similar in the US…What’s left is Samchundang Pharmaceutical? (FNTIMES) - "Celltrion and Samsung Bioepis are experiencing setbacks in the US launch of their biosimilar (generic drug) for macular degeneration treatment 'Eylea'....According to an industry source on the 10th, the US Federal Circuit Court of Appeals did not accept Celltrion's request to overturn the decision of the first trial court to ban the launch of Eylea's biosimilar on the 5th (local time)....This has made it unlikely for domestic bio companies to settle in the US market with Opuviz for the time being. Opuviz's material patent in the US expires in May of this year, but its formulation patent expires in June 2027....The company plans to apply for product approval for Ilia biosimilar 'SCD411' to the FDA within this year. Samchundang Pharmaceutical believes that SCD411 can be launched locally starting in the second half of next year....Alteogen will enter the US market after 2027."

Biosimilar launch • Age-related Macular Degeneration • Macular Degeneration • Wet Age-related Macular Degeneration

Alteogen, Eylea High-Dose Formulation Patent Priority Patent Application [Google translation] (Hankyung) - "Alteogen announced on the 26th that it has applied for a formulation patent priority for 'Eylea HD', a high-dose Eylea (ingredient name: aflibercept)...Alteogen previously developed a biosimilar of the product through the 'ALT-L9' project, and has applied for product approval through a subsidiary with the goal of clinical development and commercialization in 2025...It is expected to generate sales of approximately KRW 2 trillion in 2024 and is expected to increase to KRW 7.9 trillion in 2030, showing an average annual growth rate of 65%....This formulation patent priority application is intended to secure rights to the new formulation by focusing on Eylea HD, which has such marketability."

Biosimilar launch • Patent • Sales projection • Macular Degeneration

Alteogen seeks domestic approval for Eylea biosimilar ALT-L9 (Korea Biomedical Review) - "Alteogen...said Friday that it has applied for the domestic marketing authorization of ALT-L9, a biosimilar candidate for Eylea that treats wet age-related macular degeneration (wAMD)....In the 12-country phase 3 study by ALTOS Biologics, ALT-L9 met its primary endpoint and demonstrated therapeutic equivalence to Eylea."

Korea filing • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Altos Biologics Files Approval of Aflibercept Biosimilar (PRNewswire) - "Alteogen...announced on July 1st that its subsidiary, Altos Biologics Inc. has submitted Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for an aflibercept biosimilar ALT-L9, developed by Alteogen. The Phase 3 clinical trial for ALT-L9 commenced with initial clinical trial approval in 2022, involving over 400 subjects across 12 countries. The study compared efficacy, safety, and immunogenicity against Eylea in the indication of wet Age-related Macular Degeneration....The study demonstrated therapeutic equivalence between ALT-L9 and Eylea, prompting the submission of the Marketing Authorization Application. Altos Biologics expects to receive approval from EMA by 2025, aligned with the substance patent expiration, and intends to negotiate License Agreements with potential distributors worldwide."

EMA approval • EMA filing • Wet Age-related Macular Degeneration

[Newspim LaCiro] Alteogen "Applies for item approval for Eylea biosimilar 'ALT-L9' this year" [Google translation] (Newspim) - "As the end of phase 3 clinical trials for 'ALT-L9', a biosimilar to Alteogen's macular degeneration treatment 'Eylea', is nearing completion, Alteogen plans to complete the application for related product approval this year. The plan is to speed up commercialization....The clinical trial for 'ALT-L9' is expected to be completed in the first half of this year, and Alteogen aims to complete the product approval application within the year....'We plan to apply for product approval within the year and prepare for commercialization by next year.'"

Approval • Trial completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Alteogen commercializes - recruits key talent for development of follow-up pipeline [Google translation] (Pharm News) - "Alteogen is conducting clinical trials for approval of two SC formulation treatments using Hybrozyme™ platform technology, as well as Eylea^® biosimilar ALT-L9, which is in the final phase 3 global clinical trial, and is being clinically conducted by a partner company in China. We are pursuing commercialization around 2025 for various products, including Herceptin^® biosimilar ALT-L2, which has completed Phase 3."

Commercial • Trial completion • Age-related Macular Degeneration • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Macular Degeneration • Oncology • Ophthalmology • Solid Tumor • Wet Age-related Macular Degeneration

Alteogen, Eylia biosimilar 'ALT-L9' patent registration in Taiwan…"Secure the company's own competitiveness" (Pax Economic TV) - "Alteogen...announced on the 4th that it has registered a Taiwanese patent for the pre-filled syringe (pre-filled syringe) formulation of Eylia biosimilar ALT-L9. Eylea is a blockbuster macular degeneration treatment with sales of about 12 trillion won worldwide, and close to 10 companies are developing biosimilars in line with the substance patent expiration starting in 2024."

Patent • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Alteogen establishes quality headquarters in preparation for pipeline commercialization [Google translation] (Asia Economy) - "bio company alteogen...announced...that it had newly established a quality headquarters. This is because not only the technology-exported human hyaluronidase (ALT-B4) but also the Eylea biosimilar (ALT-L9) each entered global phase 3 clinical trials, and the importance of production and quality has increased ahead of commercialization."

Clinical • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Altos Biologics, a Subsidiary of Alteogen, Completed Patient Enrollment in Global Phase 3 Clinical Trial of Eylea Biosimilar in Neovascular Age-related Macular Degeneration (PRNewswire) - "Alteogen Inc...provided a patient enrollment update for the company's ongoing Phase 3 study of ALT-L9 for the treatment of neovascular age-related macular degeneration (wet AMD)....'We plan to complete the product approval by the first half of 2025 as biologics license application (BLA) will be submitted to the relevant health authorities in early 2024.'"

Enrollment closed • Regulatory • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Alteogen decides to register European patent for Eylia biosimilar culture process (News Farma) - "Alteogen Co., Ltd...announced...that it had received a patent registration decision for the Eylea biosimilar 'ALT-L9' culture process from the European Intellectual Property Office....Alteogen Eylia biosimilar ALT-L9 is undergoing global phase 3 clinical trials for 444 patients in 12 countries by subsidiary Altos Biologics. It plans to complete patient registration by March 2023 and launch items in line with the opening of the European market in the first half of 2025."

Enrollment status • Launch Europe • Patent • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Alteogen, U.S. Patent Registration for Manufacturing Method for Eylea's 'ALT-L9' [Google translation] (Hankyung) - "Alteogen announced...that it had received a patent grant decision (NOA) from the US Patent and Trademark Office for the culture method of 'ALT-L9', a biosimilar of Eylea. This patent is about a culture method required for ALT-L9 to have similarity to Eylea....Altos Biologics, a subsidiary of Alteogen, is conducting global phase 3 clinical trials for ALT-L9. It plans to complete clinical registration by March next year. The goal is to launch it in Europe in line with the expiration of the European patent in the first half of 2025."

Launch Europe • Patent • Regulatory • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Ministry of Food and Drug Safety approves five clinical trials including biosimilar of 'Eylia', a treatment for macular degeneration [Google translation] (Health Korea News) - "The Ministry of Food and Drug Safety approved five clinical trials...including a biosimilar of 'Eylia', a macular degeneration treatment of Bayer, a German bio company. Alteogen received approval for a phase 3 clinical trial for 'ALT-L9', a biosimilar of 'Eylea', through INC Research South Korea, a clinical trial consignment agency. The efficacy and safety of 'ALT-L9' in 40 Korean patients with neovascular age-related macular degeneration will be compared and evaluated with 'Eylea'. The implementation institutions are 7 hospitals including Pusan ​​National University Hospital."

New P3 trial • Age-related Macular Degeneration • Ophthalmology

Alteogen, Eylea similar prefilled syringe formulation PCT application [Google translation] (Digital Today) - "Alteogen filed an international patent cooperation treaty (PCT) application for the prefilled syringe (pre-filled injection) formulation of 'ALT-L9', a biosimilar candidate for 'Eylea' (ingredient name aflibercept)...The Eylea prefilled syringe formulation is in the form of filling a glass syringe, but Alteogen uses plastic."

Patent • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Prolonged Russia-Ukraine crisis, the reason why K-Bio clinical trials sparked [Google translation] (Money Today) - "...is pursuing a global phase 3 clinical trial of 'ALT-L9', a drug candidate for wet macular degeneration , chose to exclude Russia and Ukraine for now. Initially, clinical trials were scheduled to be conducted at 100 clinical institutions in 20 countries, including Korea, Russia and Ukraine, but the plan is to prioritize other countries as the situation is not favorable."

Clinical • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

“Higher target price if Alteogen ALT-L9 copyright contract is reached“ Hyundai Motor Securities [Google translation] (Sedaily) - "'The ALT-L9 phase 1 clinical intangible capitalization is estimated at about 10 billion won'. Hyundai Motor Securities announced...that it would raise its target price once Alteogen (196170)'s 'ALT-L9' contract for the copyright and 'ALT-B4' technology export are completed."

Commercial • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Randomized, Phase 3, Double Masked, Parallel Group, Multicenter Study to Compare the Efficacy and Safety of ALT L9 Versus Eylea® (clinicaltrialsregister.eu) - P3 | N=444 | Ongoing | Sponsor: Altos Biologics Inc.

New P3 trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Clinical Study of ALT-L9 to Determine Safety, Efficacy and Pharmacokinetics in Neovascular AMD (clinicaltrials.gov) - P1; N=28; Completed; Sponsor: Alteogen, Inc.; Not yet recruiting ➔ Completed

Clinical • Trial completion • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Alteogen, "We will negotiate technology export contracts with 4 global pharmaceutical companies" [Google translation] (Financial News) - "Alteogen plans to negotiate a technology export contract with four global pharmaceutical companies...Alteogen will participate in the '40th JP Morgan Healthcare Conference and Biotech Showcase 2022' held online from the 10th to the 13th (local time) in San Francisco, USA. do. At this event, the company plans to sign a non-disclosure agreement (CDA) and a material transfer agreement (MTA) with four of the world's top 10 pharmaceutical companies and negotiate a full-fledged technology export contract. Alteogen is also scheduled to hold a meeting with leading global pharmaceutical companies to sign a marketing partner contract for the Eylea biosimilar ALT-L9."

Clinical • Licensing / partnership • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Park Soon-jae, CEO of Alteogen, "Promoting phase 3 clinical trials for macular degeneration treatment in 22 countries" [Google translation] (Hankyung) - "Alteogen plans to conduct phase 3 clinical trials of ALT-L9 at 100 medical institutions in 22 countries early next year. ALT-L9 is a biosimilar of Eylea, a macular degeneration treatment, which was jointly developed by Bayer of Germany and Regeneron of the United States and generated sales of about 9.3 trillion won last year."

New P3 trial • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Pipeline therapies for neovascular age related macular degeneration. (PubMed, Int J Retina Vitreous) - "Prior treatments have included focal laser therapy, verteporfin (Visudyne, Bausch and Lomb, Rochester, New York) ocular photodynamic therapy, transpupillary thermotherapy, intravitreal steroids and surgical excision of choroidal neovascular membranes. Currently, the major therapies in AMD focus on the VEGF-A pathway, of which the most common are bevacizumab (Avastin; Genentech, San Francisco, California), ranibizumab (Lucentis; Genentech, South San Francisco, California), and aflibercept (Eylea; Regeneron, Tarrytown, New York)...Cheaper alternatives, including ranibizumab biosimilars, include razumab (Intas Pharmaceuticals Ltd., Ahmedabad, India), FYB 201 (Formycon AG, Munich, Germany and Bioeq Gmbh Holzkirchen, Germany), SB-11 (Samsung Bioepsis, Incheon, South Korea), xlucane (Xbrane Biopharma, Solna, Sweden), PF582 (Pfnex, San Diego, California), CHS3551 (Coherus BioSciences, Redwood City, California). Additionally, aflibercept biosimilars under development include..."

Journal • Review • Age-related Macular Degeneration • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Alteogen Announces Final Results of Domestic Phase 1 'Eylea Similar' [Google translation] (Biospectator) - P1, N=30; NCT04058535; Sponsor: Alteogen, Inc.; "Alteogen announced...results of the domestic phase 1 clinical top-line of 'ALT-L9', an Amilia biosimilar. According to the final report, the safety and efficacy of ALT-L9 in this phase 1 clinical trial were similar to those of Eylea...Specifically, at 12 weeks of drug administration, the average change compared to before administration was ALT-L9 3.50±5.24 (p=0.0267) and Eylea 2.86±9.69 (p=0.0256), and there was no difference between the two groups...Alteogen plans to conduct follow-up global phase 3 clinical trials in 13 countries, including Korea, Japan, and Europe, and plans to enter phase 3 clinical trials in the fourth quarter of this year or the first quarter of next year. The global phase 3 clinical trial will be conducted under a contract with Syneos Health, a clinical trial contracting company (CRO). As a result, product approval is targeted for 2025."

New P3 trial • P1 data • Regulatory • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Korean drugmakers speed up clinical trials of Eyelea biosimilars (Korea Biomedical Review) - "The product patent of Eyelea, jointly developed by Regeneron Pharmaceuticals and Bayer, will expire in 2024 in East Asia, 2025 in Europe, and 2028 in the U.S...Samsung Bioepis has been conducting global phase 3 clinical trials of SB15 since July 2020...It will conduct the clinical trials in 10 countries, including Korea and the U.S., and complete them by the end of February 2022...ALT-L9. The company plans to develop the drug through its subsidiary Altos Biologics and commercialize the biosimilar in Europe by 2025...Samchundang Pharm has speeded up its phase 3 clinical trials of SCD411. The company targets U.S. and Japanese approval in 2023."

Biosimilar launch • BLA • Japanese regulatory • Patent • Trial completion date • Age-related Macular Degeneration • Diabetic Macular Edema • Ophthalmology

Alteogen completes phase 1 clinical trial of Eylea biosimilar (Korea Biomedical Review) - "Alteogen...has completed phase 1 clinical trial of ALT-L9... treats macular degeneration, for the first time in Korea...Alteogen conducted its first local clinical trial of the biosimilar at four hospitals -- Seoul Asan Medical Center, Samsung Seoul Hospital, Seoul National University Bundang Hospital, and Samsung Medical Center...The test result showed that no drug-related adverse effects were observed in Eylea and ALT-L9."

Trial completion • Diabetic Macular Edema • Ophthalmology

Catch’Ilia Biosimilar’… advanced competition (Business Watch) - "Alteogen completed the administration of ILLIA biosimilar 'ALT-L9' to patients in phase 1 clinical trials in Korea. In particular, in order to proceed with the global phase 3 clinical trial of 'ALT-L9' at the end of this year..."

New P3 trial • Ophthalmology

Proliferative Diabetic Retinopathy: Anti-VEGF or Vitrectomy for Vitreous Hemorrhage? (Physician’s Weekly) - '"Vitreous hemorrhage from retinal neovascularization is a frequent occurrence of proliferative diabetic retinopathy and can cause acute, severe vision loss,' wrote researchers from the DRCR Retina Network, led by Andrew N. Antoszyk, MD..."

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