AVT23 (omalizumab biosimilar) / Kashiv Biosci, Alvotech, Advanz Pharma - LARVOL DELTA

A Open Label ,Randomized, Balanced, Two-treatment, Single Period, Parallel, Comparative Pharmacokinetic Study in Healthy Subjects (clinicaltrials.gov) - P1 | N=150 | Recruiting | Sponsor: Kashiv BioSciences, LLC

New P1 trial • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

UK Medicines and Healthcare Products Regulatory Agency Confirms Acceptance of Marketing Authorization Application for Proposed Biosimilar to Xolair (omalizumab) (GlobeNewswire) - "Alvotech...today announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted a marketing application for AVT23, a proposed biosimilar to Xolair (omalizumab), a biologic indicated for treatment of severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps. Global sales of Xolair in 2024 were about USD $4.4 billion."

MHRA approval • Sales • Asthma • Chronic Rhinosinusitis With Nasal Polyps

Study to Compare Efficacy Safety and Immunogenicity of ADL-018 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria (clinicaltrials.gov) - P3 | N=600 | Completed | Sponsor: Kashiv BioSciences, LLC | Recruiting ➔ Completed | Trial completion date: Apr 2025 ➔ Dec 2024

Trial completion • Trial completion date • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

PK, PD, Safety & Immunogenicity of ADL-018 Lyo in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=204 | Completed | Sponsor: Kashiv BioSciences, LLC | Recruiting ➔ Completed

Trial completion

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

Kashiv BioSciences Announces Completion of Enrollment for Phase III Clinical Trial of ADL018, a Biosimilar Candidate to XOLAIR (omalizumab) (Businesswire) - "Kashiv BioSciences, LLC today announced the completion of patient enrollment for its Phase III clinical trial of ADL018, a biosimilar candidate to XOLAIR. This pivotal study aims to compare the efficacy, safety, tolerability, and immunogenicity of ADL018 with XOLAIR in patients with chronic idiopathic/spontaneous urticaria (CSU) who remain symptomatic despite taking H1 antagonists."

Enrollment closed • Chronic Spontaneous Urticaria • Immunology • Urticaria

Amneal Expands Biosimilars Portfolio to Eight Products with Addition of Omalizumab Biosimilar (Businesswire) - "Amneal Pharmaceuticals, Inc...today announced the addition of omalizumab, referencing XOLAIR, to its biosimilar pipeline....'We are pleased to partner with Amneal on our most advanced pipeline product, ADL018, a proposed biosimilar to XOLAIR.'"

Licensing / partnership • Asthma • Chronic Spontaneous Urticaria • Immunology • Urticaria

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

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

Alvotech Enters into Exclusive Licensing Agreement with Kashiv BioSciences for Development and Commercialization of a Proposed Biosimilar to Xolair (omalizumab) (GlobeNewswire) - "Alvotech...and Kashiv Biosciences LLC...today announced that they have entered into an exclusive licensing agreement for AVT23 (also called ADL018), a proposed biosimilar to Xolair® (omalizumab), which is currently in clinical development. The agreement covers all 27 countries of the European Union, the UK, Australia, Canada, and New Zealand. Under terms of the agreement, Alvotech will receive an exclusive license to commercialize AVT23, which will be developed and manufactured by Kashiv. Kashiv will receive an upfront payment and is eligible for subsequent milestone payments and royalties."

Licensing / partnership • Asthma • Chronic Spontaneous Urticaria • Dermatology • Immunology • Respiratory Diseases • Urticaria

"$ALVO Alvotech enters into commercialization agreement with Advanz Pharma for proposed biosimilar to Xolair® (omalizumab) https://t.co/FjllEXFy9y" (@stock_titan)

M&A

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

Kashiv BioSciences Enrolls First Patient in Phase III Clinical Study for ADL018, A Biosimilar Candidate to XOLAIR (omalizumab) (Businesswire) - "Kashiv announced completion of a successful global Phase 1 clinical study in healthy volunteers for ADL018 in June 2023....Kashiv BioSciences, LLC...today announced that it has enrolled the first patient in its Phase III clinical study involving ADL018, the Company’s biosimilar candidate to XOLAIR®. The objective of the study is to compare ADL018 and XOLAIR® in terms of efficacy, safety, tolerability, and immunogenicity in patients with chronic idiopathic/spontaneous urticaria (CSU) who remain symptomatic on H1 antihistamine treatment. The study is expected to enroll 600 patients globally in sites across the United States, Europe, and India..."

Enrollment open • Trial completion • Asthma • Chronic Spontaneous Urticaria • Immunology • Urticaria

Study to Compare Efficacy Safety and Immunogenicity of ADL-018 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria (clinicaltrials.gov) - P3 | N=600 | Recruiting | Sponsor: Kashiv BioSciences, LLC | Active, not recruiting ➔ Recruiting

Enrollment open • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Study to Compare Efficacy Safety and Immunogenicity of ADL-018 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria (clinicaltrials.gov) - P3 | N=600 | Active, not recruiting | Sponsor: Kashiv BioSciences, LLC | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Study to Compare Efficacy Safety and Immunogenicity of ADL-018 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria (clinicaltrials.gov) - P3 | N=600 | Not yet recruiting | Sponsor: Kashiv BioSciences, LLC | Trial completion date: Jun 2024 ➔ Apr 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

To Compare the PK, PD, Safety & Immunogenicity of ADL-018 in Healthy Subjects (clinicaltrials.gov) - P1 | N=306 | Completed | Sponsor: Kashiv BioSciences, LLC | Recruiting ➔ Completed | Trial primary completion date: Jun 2023 ➔ Feb 2023

Trial completion • Trial primary completion date

Kashiv Biosciences Announces Successful Phase 1 Study Results of ADL018, A Biosimilar Candidate to Xolair (omalizumab) (Businesswire) - P1 | N=306 | NCT05413161 | Sponsor: Kashiv BioSciences, LLC | "Kashiv Biosciences, LLC...announced that ADL018, a biosimilar candidate to Xolair^® (omalizumab), completed a successful global Phase 1 clinical study in healthy volunteers....'We are looking forward to initiating dosing in the global Phase 3 study soon in chronic spontaneous urticaria (CSU) patients'....According to IQVIA®, worldwide and U.S. annual sales for Xolair® for the 12 months ended December 2022 were ~$4.0 billion and $2.8 billion, respectively....'For all comparisons of primary endpoints (AUCinf and Cmax), the 90% confidence intervals (CIs) of the geometric least squares means ratio were fully contained within the pre-defined equivalence margin of 0.80-1.25. The IgE levels, safety profiles and immunogenicity were also comparable among the three treatment groups'."

P1 data • Sales • Trial status • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

PK, PD, Safety & Immunogenicity of ADL-018 Lyo in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=204 | Recruiting | Sponsor: Kashiv BioSciences, LLC | Trial completion date: Mar 2023 ➔ Aug 2023 | Trial primary completion date: Feb 2023 ➔ Jul 2023

Trial completion date • Trial primary completion date

To Compare the PK, PD, Safety & Immunogenicity of ADL-018 in Healthy Subjects (clinicaltrials.gov) - P1 | N=306 | Recruiting | Sponsor: Kashiv BioSciences, LLC | Trial primary completion date: Apr 2023 ➔ Jun 2023

Trial primary completion date

Study to Compare Efficacy Safety and Immunogenicity of ADL-018 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria (clinicaltrials.gov) - P3 | N=600 | Not yet recruiting | Sponsor: Kashiv BioSciences, LLC

New P3 trial • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

To Compare the PK, PD, Safety & Immunogenicity of ADL-018 in Healthy Subjects (clinicaltrials.gov) - P1 | N=306 | Recruiting | Sponsor: Kashiv BioSciences, LLC | Trial primary completion date: Jan 2023 ➔ Apr 2023

Trial primary completion date

PK, PD, Safety & Immunogenicity of ADL-018 Lyo in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=204 | Recruiting | Sponsor: Kashiv BioSciences, LLC | Not yet recruiting ➔ Recruiting

Enrollment open

PK, PD, Safety & Immunogenicity of ADL-018 Lyo in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=204 | Not yet recruiting | Sponsor: Kashiv BioSciences, LLC

New P1 trial

To Compare the PK, PD, Safety & Immunogenicity of ADL-018 in Healthy Subjects (clinicaltrials.gov) - P1 | N=306 | Recruiting | Sponsor: Kashiv BioSciences, LLC | Not yet recruiting ➔ Recruiting

Enrollment open