AVT16 (vedolizumab biosimilar) / Alvotech, JAMP Pharma, Advanz Pharma - LARVOL DELTA

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

Pilot Study of AVT16 in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: Alvotech Swiss AG | Active, not recruiting ➔ Completed

Trial completion

Study to Investigate Comparative Efficacy, Safety and Immunogenicity Between AVT16 and Entyvio (clinicaltrials.gov) - P3 | N=748 | Recruiting | Sponsor: Alvotech Swiss AG | Not yet recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

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

Alvotech Initiates Confirmatory Patient Study for AVT16, a Proposed Biosimilar to Entyvio (GlobeNewswire) - "Alvotech...announced today the initiation of a confirmatory patient study for AVT16, a biosimilar candidate to Entyvio (vedolizumab). The objective of the study is to demonstrate comparative efficacy, safety, and immunogenicity of AVT16 and Entyvio, in male and female participants 18-80 years old with moderate to severe active Ulcerative Colitis. Alvotech is one of two companies known to have initiated a global or multi-country confirmatory patient study for a biosimilar candidate to Entyvio."

Patent • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Study to Investigate Comparative Efficacy, Safety and Immunogenicity Between AVT16 and Entyvio (clinicaltrials.gov) - P3 | N=748 | Not yet recruiting | Sponsor: Alvotech Swiss AG

New P3 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Pilot Study of AVT16 in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=18 | Active, not recruiting | Sponsor: Alvotech Swiss AG | Recruiting ➔ Active, not recruiting

Enrollment closed

Pilot Study of AVT16 in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Alvotech Swiss AG | Not yet recruiting ➔ Recruiting

Enrollment open

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

Pilot Study of AVT16 in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Alvotech Swiss AG

New P1 trial

Alvotech And Advanz Pharma Extend Partnership To Commercialize Five Proposed Biosimilars In Europe (Market Screener) - "Advanz Pharma...and Alvotech announced that they entered an exclusive partnership agreement regarding supply and commercialization of five biosimilars in Europe, with Alvotech responsible for the development and commercial supply of the biosimilars, and Advanz responsible for registration and commercialization in Europe. Per the announcement, the agreement includes proposed biosimilars to SIMPONI® (golimumab) and ENTYVIO® (vedolizumab) and three undisclosed, early stage biosimilar candidates. According to IQVIA, the current market for these five biosimilars covered by the agreement, within the markets covered by the agreement, exceeds $4 billion."

Licensing / partnership • Immunology

Alvotech and JAMP Pharma Expand Exclusive Partnership Adding Two Biosimilar Candidates for Canadian Market, Bringing New Options for Patients in Specialty Care (GlobeNewswire) - "Alvotech...and the JAMP Pharma Group...announced today that the companies have expanded their exclusive partnership to commercialize biosimilars developed and manufactured by Alvotech, by adding two biosimilar candidates from Alvotech’s pipeline: AVT16 a biosimilar for an immunology product and AVT33, a biosimilar for an oncology product....Alvotech will be responsible for the development and commercial supply of the biosimilar candidates. In exchange for milestone payments and future sales royalties, JAMP Pharma will receive exclusive rights to commercialize Alvotech’s biosimilars in Canada, leveraging JAMP Pharma’s strong sales, marketing capabilities and experience in successfully commercializing new biosimilars in the fast-growing Canadian market."

Licensing / partnership • Immunology • Oncology