AVT03 (denosumab biosimilar) / Alvotech, Dr. Reddy’s - LARVOL DELTA

Alvotech and Dr. Reddy’s Announce FDA acceptance of Biologic License Application for AVT03, a Proposed Biosimilar to Prolia and Xgeva (GlobeNewswire) - "Dr. Reddy’s Laboratories Ltd...announced that the U.S. Food and Drug Administration (FDA) has accepted a 351(k) Biologic License Application (BLA) submission for AVT03, developed by Alvotech, a proposed biosimilar of Prolia (denosumab) and Xgeva (denosumab)."

FDA filing • Osteoporosis

Multicenter Study in Postmenopausal Women with Osteoporosis, ALVOBOND (clinicaltrials.gov) - P3 | N=532 | Completed | Sponsor: Alvotech Swiss AG | Active, not recruiting ➔ Completed

Trial completion • Osteoporosis • Rheumatology

AVT03 With Xgeva in Healthy Male Subjects (clinicaltrials.gov) - P1 | N=208 | Completed | Sponsor: Alvotech Swiss AG | Active, not recruiting ➔ Completed

Trial completion

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 and Dr. Reddy’s enter into collaboration for commercialization of AVT03 (denosumab), a biosimilar candidate to Prolia & Xgeva in the U.S., Europe and UK (GlobeNewswire) - "Alvotech...and Dr. Reddy’s Laboratories SA, wholly-owned subsidiary of Dr. Reddy’s Laboratories Ltd...announced that the companies have entered into a license and supply agreement for the commercialization of AVT03, Alvotech’s biosimilar candidate to Prolia and Xgeva (denosumab). The collaboration combines Dr. Reddy’s global commercial presence with Alvotech’s proven capabilities in developing biosimilars for markets worldwide."

Licensing / partnership • Metabolic Disorders • Oncology

AVT03 With Prolia in Healthy Male Subjects (clinicaltrials.gov) - P1 | N=209 | Completed | Sponsor: Alvotech Swiss AG | Active, not recruiting ➔ Completed

Trial completion

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 Announces Positive Top-Line Results from a Pharmacokinetic Study for AVT03, a Proposed Biosimilar for Prolia and Xgeva (GlobeNewswire) - "Alvotech...announced...positive top-line results from a pharmacokinetic (PK) study for AVT03...The PK study (AVT03-GL-P01), which assessed the pharmacokinetics, safety, and tolerability of AVT03 compared to Prolia in healthy adult subjects, met its primary endpoints....In the last twelve months before September 30, 2023, reported combined net revenues worldwide from sales of Prolia and Xgeva were over US$6 billion, based on the manufacturer’s reported quarterly sales."

PK/PD data • Sales • Giant Cell Tumor of Bone • Osteoporosis

AVT03 With Prolia in Healthy Male Subjects (clinicaltrials.gov) - P1 | N=209 | Active, not recruiting | Sponsor: Alvotech Swiss AG | Recruiting ➔ Active, not recruiting | Phase classification: PN/A ➔ P1

Enrollment closed • Phase classification

Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND (clinicaltrials.gov) - P3 | N=532 | Active, not recruiting | Sponsor: Alvotech Swiss AG | Trial completion date: Apr 2025 ➔ Oct 2024

Trial completion date • Osteoporosis • Rheumatology

AVT03 With Xgeva in Healthy Male Subjects (clinicaltrials.gov) - P1 | N=208 | Active, not recruiting | Sponsor: Alvotech Swiss AG | Recruiting ➔ Active, not recruiting

Enrollment closed

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

AVT03 With Xgeva in Healthy Male Subjects (clinicaltrials.gov) - P1 | N=206 | Recruiting | Sponsor: Alvotech Swiss AG | Not yet recruiting ➔ Recruiting

Enrollment open • Osteoporosis • Rheumatology

AVT03 With Prolia in Healthy Male Subjects (clinicaltrials.gov) - P=N/A | N=206 | Recruiting | Sponsor: Alvotech Swiss AG | Active, not recruiting ➔ Recruiting

Enrollment open

AVT03 With Xgeva in Healthy Male Subjects (clinicaltrials.gov) - P1 | N=206 | Not yet recruiting | Sponsor: Alvotech Swiss AG

New P1 trial • Osteoporosis • Rheumatology

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

Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND (clinicaltrials.gov) - P3 | N=476 | Active, not recruiting | Sponsor: Alvotech Swiss AG | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2024 ➔ Apr 2025

Enrollment closed • Trial completion date • Osteoporosis • Rheumatology

AVT03 With Prolia in Healthy Male Subjects (clinicaltrials.gov) - P=N/A | N=206 | Active, not recruiting | Sponsor: Alvotech Swiss AG | Recruiting ➔ Active, not recruiting

Enrollment closed

Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND (clinicaltrials.gov) - P3 | N=476 | Recruiting | Sponsor: Alvotech Swiss AG | Not yet recruiting ➔ Recruiting

Enrollment open • Osteoporosis • Rheumatology

"$ALVO Alvotech Initiates Confirmatory Patient Study for AVT03, a Proposed Biosimilar for Prolia® and Xgeva® https://t.co/M6NoEuab1N" (@stock_titan)

Clinical

AVT03 With Prolia in Healthy Male Subjects (clinicaltrials.gov) - P=N/A | N=206 | Recruiting | Sponsor: Alvotech Swiss AG | Not yet recruiting ➔ Recruiting | Phase classification: P1 ➔ PN/A

Enrollment open • Phase classification

"$ALVO Alvotech Initiates a Pharmacokinetic Study for AVT03, a Proposed Biosimilar for Prolia® and Xgeva® https://t.co/ZhHuOtf7Rg" (@stock_titan)

PK/PD data