AVT06 (aflibercept low dose biosimilar) / Cipla, Alvotech, Stada, Fuji Pharma, Teva, Polifarma, Advanz Pharma, Servier - LARVOL DELTA

ALVOEYE-D: Clinical Study to Evaluate the Handling and Safety of AVT06 PFS in Subjects With Chorioretinal Vascular Disease (clinicaltrials.gov) - P3 | N=35 | Completed | Sponsor: Alvotech Swiss AG | Active, not recruiting ➔ Completed

Trial completion • Wet Age-related Macular Degeneration

Alvotech Reports Record Results for 2024 and Provides Business Update (GlobeNewswire) - "Product revenue was $273.5 million for the year ended December 31, 2024, compared to $48.7 million for the same period in the prior year. Revenue for the year ended 31 December 2024, consisted of product revenue from sales of AVT02 in select European countries and Canada, launch of AVT02 in the U.S., and the launches of AVT04 in Canada, Japan and select European markets....The license and other revenue of $216.2 million was primarily attributable to the achievement of key research and development milestones during 2024: $6.6 million for the approval of AVT04 in Europe, $16.8 million for the CTA submission for AVT16, a total of $34.4 million for the MAA submissions with the EMA for...AVT05, and AVT06, $39.1 million for the CES completion of...and $56.4 million for the CES completion of AVT05."

Commercial • Sales • Age-related Macular Degeneration • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ophthalmology • Ulcerative Colitis • Wet Age-related Macular Degeneration

Comparative Efficacy and Safety of Candidate Biosimilar AVT06 and Reference Product Aflibercept (ARVO 2025) - P3 | "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Clinical • Age-related Macular Degeneration • Diabetic Retinopathy • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Handling and Safety of Candidate Biosimilar AVT06 PFS in Participants with Chorioretinal Vascular Disease (ARVO 2025) - P3 | "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Clinical • Ophthalmology

Alvotech and Teva Announce Filing Acceptance of U.S. Biologics License Application for AVT06, a Proposed Biosimilar to Eylea (aflibercept) (GlobeNewswire) - "Alvotech...and Teva Pharmaceuticals...announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06, Alvotech’s proposed biosimilar to Eylea (aflibercept), a biologic used to treat eye disorders, including diseases which can lead to vision loss or blindness. The process to obtain regulatory approval is anticipated to be completed in the fourth quarter of 2025....In January 2024, Alvotech announced positive top-line results from a confirmatory clinical study (AVT06-GL-C01) comparing the efficacy, safety, and immunogenicity of AVT06 with Eylea in patients with neovascular (wet) AMD."

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

Alvotech Reports Financial Results for the First Nine Months of 2024 (GlobeNewswire) - "Research and development (R&D) expenses: R&D expenses were $131.1 million for the nine months ended September 30, 2024, compared to $152.8 million for the same nine months of 2023. The decrease was primarily driven by a one-time charge of $18.5 million relating to the termination of the co-development agreement with Biosana for AVT23 recognized during the nine months of 2023, a decrease of $4.3 million primarily related to programs which have completed clinical phase (i.e., AVT02 and AVT04 programs), a decrease of $6.0 million related to programs for which the clinical phase is substantially completed (i.e. AVT03, AVT05, and AVT06), and overall lower headcount and other R&D expenses of $11.4 million, partially offset by a $17.4 million increase in direct program expenses mainly due to AVT16 that is in clinical phase."

Commercial • Age-related Macular Degeneration • Asthma • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ophthalmology • Psoriasis • Ulcerative Colitis • Wet Age-related Macular Degeneration

Clinical Study to Compare Efficacy and Safety of AVT06 and EU-Eylea (ALVOEYE) (clinicaltrials.gov) - P3 | N=413 | Completed | Sponsor: Alvotech Swiss AG | Active, not recruiting ➔ Completed

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

European Medicines Agency Confirms Acceptance of Marketing Application for AVT06, a Proposed Biosimilar to Eylea (aflibercept) (GlobeNewswire) - "Alvotech...today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT06, Alvotech’s proposed biosimilar to Eylea (aflibercept). The process to obtain marketing authorization could be completed in the third quarter of 2025."

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

Alvotech and Advanz Pharma Sign Commercialization Agreement for Proposed Biosimilar to Eylea LD/HD in Europe (GlobeNewswire) - "Alvotech...announced that the companies have entered into an exclusive partnership agreement regarding the supply and commercialization of Alvotech’s proposed biosimilar to Eylea (aflibercept). Alvotech is currently developing AVT06, a proposed biosimilar to Eylea low dose (2 mg) and AVT29, a biosimilar candidate for Eylea high dose (8 mg)....Under the agreement, Alvotech will be responsible for development and commercial supply of AVT06 and AVT29, and Advanz Pharma will be responsible for registration and commercialization."

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

Clinical Study to Compare Efficacy and Safety of AVT06 and EU-Eylea (ALVOEYE) (clinicaltrials.gov) - P3 | N=413 | Active, not recruiting | Sponsor: Alvotech Swiss AG | Trial completion date: Jan 2025 ➔ Oct 2024

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

Alvotech Reports Financial Results for First Quarter of 2024 and Provides a Business Update (GlobeNewswire) - "Product revenue was $12.4 million for the three months ended March 31, 2024, compared to $15.7 million for the same three months of 2023. Revenue for the three months ended March 31, 2024, consisted of product revenue from sales of AVT02 in select European countries and Canada, launch of AVT02 in the U.S and launch of AVT04 in Canada....R&D expenses were $49.9 million for the three months ended March 31, 2024, compared to $50.9 million for the same three months of 2023. The slight decrease was primarily driven by a one-time charge of $18.5 million relating to the termination of the co-development agreement with Biosana for AVT23 recognized during the three months of 2023, and a $17.8 million increase in direct program expenses mainly from five biosimilar candidates, AVT03, AVT05, AVT06, AVT16 and AVT23 that are in clinical phase."

Commercial • Age-related Macular Degeneration • Asthma • Crohn's disease • Immunology • Inflammatory Bowel Disease • Metabolic Disorders • Ophthalmology • Respiratory Diseases • Ulcerative Colitis • Wet Age-related Macular Degeneration

ALVOEYE-D: Clinical Study to Evaluate the Handling and Safety of AVT06 PFS in Subjects With Chorioretinal Vascular Disease (clinicaltrials.gov) - P3 | N=35 | Active, not recruiting | Sponsor: Alvotech Swiss AG | Recruiting ➔ Active, not recruiting

Enrollment closed • Wet Age-related Macular Degeneration

Alvotech Reports Financial Results for Full Year 2023 and Provides a Business Update (GlobeNewswire) - "Cost of product revenue: Cost of product revenue was $160.9 million for the year ended December 31, 2023, as a result of the successful launch of AVT02 in select European countries, Canada and Australia....Research and Development (R&D) Expenses: R&D expenses were $210.8 million for the year ended December 31, 2023, compared to $180.6 million for the same period in the prior year. The increase was primarily driven by a charge of $18.5 million relating to the termination of the co-development agreement with Biosana for AVT23, and a $42.5 million increase in direct program expenses mainly from three biosimilar candidates, AVT03, AVT05 and AVT06, that entered clinical development in 2022."

Commercial • Age-related Macular Degeneration • Asthma • Crohn's disease • Immunology • Inflammatory Bowel Disease • Metabolic Disorders • Ophthalmology • Psoriasis • Respiratory Diseases • Ulcerative Colitis • Wet Age-related Macular Degeneration

ALVOEYE-D: Clinical Study to Evaluate the Handling and Safety of AVT06 PFS in Subjects With Chorioretinal Vascular Disease (clinicaltrials.gov) - P3 | N=35 | Recruiting | Sponsor: Alvotech Swiss AG | Not yet recruiting ➔ Recruiting

Enrollment open • Wet Age-related Macular Degeneration

ALVOEYE-D: Clinical Study to Evaluate the Handling and Safety of AVT06 PFS in Subjects With Chorioretinal Vascular Disease (clinicaltrials.gov) - P3 | N=35 | Not yet recruiting | Sponsor: Alvotech Swiss AG | Initiation date: Nov 2023 ➔ Mar 2024 | Trial primary completion date: Feb 2024 ➔ May 2024

Trial initiation date • Trial primary completion date • Wet Age-related Macular Degeneration

Alvotech Clinical Study Results Demonstrate Therapeutic Equivalence between Biosimilar Candidate AVT06 and Reference Product Eylea (aflibercept) (Alvotech Press Release) - P3 | N=413 | ALVOEYE (NCT05155293) | Sponsor: Alvotech Swiss AG | "Alvotech...today announced positive top-line results from a confirmatory clinical study for AVT06, Alvotech’s proposed biosimilar to Eylea^® (aflibercept)....The AVT06-GL-C01 confirmatory clinical study is a randomized, double-masked, parallel-group, multicenter, therapeutic equivalence study evaluating the efficacy, safety, and immunogenicity of AVT06 compared with Eylea in patients with neovascular (wet) AMD. The primary outcome measure was change from baseline to Week 8 in Best-Corrected Visual Acuity (BCVA). The study met its primary endpoint, with results demonstrating therapeutic equivalence between Alvotech’s biosimilar candidate and Eylea."

P3 data: top line • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Alvotech Reports Financial Results for First Six Months of 2023 and Provides Business Update (GlobeNewswire) - "Cost of product revenue: Cost of product revenue was $67.9 million for the six months ended June 30, 2023, as a result of the successful launch of AVT02 in select European countries and Canada....R&D expenses were $99.6 million for the six months ended June 30, 2023, compared to $86.9 million for the same six months of 2022. The increase was primarily driven by a one-time charge of $18.5 million relating to the termination of the co-development agreement with Biosana for AVT23, and a $24.6 million increase in direct program expenses mainly from three biosimilar candidates, AVT03, AVT05 and AVT06, that entered clinical development in 2022."

Commercial • Age-related Macular Degeneration • Asthma • Crohn's disease • Immunology • Inflammatory Bowel Disease • Metabolic Disorders • Ophthalmology • Psoriasis • Respiratory Diseases • Ulcerative Colitis • Wet Age-related Macular Degeneration

Clinical Study to Compare Efficacy and Safety of AVT06 and EU-Eylea (ALVOEYE) (clinicaltrials.gov) - P3 | N=413 | Active, not recruiting | Sponsor: Alvotech Swiss AG | Recruiting ➔ Active, not recruiting | Trial primary completion date: Aug 2023 ➔ Dec 2023

Enrollment closed • Trial primary completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

ALVOEYE-D: Clinical Study to Evaluate the Handling and Safety of AVT06 PFS in Subjects With Chorioretinal Vascular Disease (clinicaltrials.gov) - P3 | N=35 | Not yet recruiting | Sponsor: Alvotech Swiss AG

New P3 trial • Wet Age-related Macular Degeneration

Clinical Study to Compare Efficacy and Safety of AVT06 and EU-Eylea (ALVOEYE) (clinicaltrials.gov) - P3 | N=444 | Recruiting | Sponsor: Alvotech Swiss AG | Trial completion date: Dec 2023 ➔ Dec 2024

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

Alvotech Reports Financial Results for First three Months of 2023 and Provides Business Update (GlobeNewswire) - "R&D expenses were $50.9 million for the three months ended March 31, 2023, compared to $47.1 million for the same three months of 2022...and a $10.5 million increase in direct program expenses mainly from three biosimilar candidates, AVT03 and AVT06, that entered clinical development in 2022 and AVT05 that entered clinical development in 2023. These increases were partially offset by a decrease in spending of $13.8 million primarily related to programs for which the clinical activities were winding down. In addition, there was a reclassification of pre-commercial manufacturing activities of $12.4 million, that were previously recognized as R&D expense, which are now being recognized as cost of product revenue, in conjunction with the Company’s commercial launch of AVT02."

Commercial • Age-related Macular Degeneration • Crohn's disease • Immunology • Inflammatory Bowel Disease • Oncology • Ophthalmology • Osteoporosis • Ulcerative Colitis • Wet Age-related Macular Degeneration

Alvotech enters into commercialization agreement with Polifarma for proposed biosimilar to Eylea (aflibercept) (GlobeNewswire) - "Alvotech...announced that it has entered into an exclusive agreement with Polifarma Ilac San. ve tic. A.S. ('Polifarma') for the commercialization in Turkey of AVT06, a proposed biosimilar to Eylea® (aflibercept)....According to the agreement, Alvotech will be responsible for development and manufacture, while Polifarma will handle market registration and commercialization."

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

Clinical Study to Compare Efficacy and Safety of AVT06 and EU-Eylea (ALVOEYE) (clinicaltrials.gov) - P3 | N=444 | Recruiting | Sponsor: Alvotech Swiss AG | Trial primary completion date: Feb 2023 ➔ Jun 2023

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

Clinical dose of AVT06 vehicle and drug product show no increased toxicity compared with reference aflibercept in primary retinal cells in vitro (ARVO 2023) - "Purpose Reference product (RP) aflibercept (Eylea®) is a soluble decoy VEGF-A receptor which reduces angiogenesis and vascular permeability, lessening vascular inflammation and leukocyte infiltration and downstream vision loss in several macular related diseases. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Preclinical • Ophthalmology

Clinical Study to Compare Efficacy and Safety of AVT06 and EU-Eylea (ALVOEYE) (clinicaltrials.gov) - P3 | N=444 | Recruiting | Sponsor: Alvotech Swiss AG | Not yet recruiting ➔ Recruiting

Enrollment open • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration