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The study, which evaluated the pharmacokinetics, safety, and tolerability of AVT03 compared to Prolia® in healthy adult subjects, met its number one endpoint.
Prolia® and Xgeva® (denosumab) are indicated for the remedy of bone diseases
Alvotech (NASDAQ: ALVO), a global biotechnology company focused on the development and production of biosimilars for patients around the world, announced positive first-line effects from a pharmacokinetic (PK) study of AVT03, a biosimilar candidate from Prolia® and Xgeva®. any of which involve denosumab.
The pharmacokinetic study (AVT03-GL-P01), which evaluated the pharmacokinetics, protection, and tolerability of AVT03 compared to Prolia® in healthy adult subjects, met its primary endpoints. A study is currently underway to verify the efficacy of AVT03 in patients, as well as a pharmacokinetic study comparing AVT03 with Xgeva® in healthy adult subjects.
“We are very pleased with the progress of our AVT03 program. This milestone and the recent positive effects of other clinical studies clearly demonstrate our functions and the excellence of Alvotech’s biosimilar progression platform,” said Joseph McClellan, Chief Scientific Officer.
Prolia (denosumab) is indicated for the treatment of osteoporosis in postmenopausal women and for bone loss in adult men and women at increased risk of fracture. Xgeva, which is also denosumab but in a different form, is indicated for the prevention of skeletal-related diseases. Occasions as pathological fractures in adults with complex malignancies affecting the bones. It is also indicated for the treatment of giant mobile bone tumors. In the twelve months to September 30, 2023, combined international net income was reported from the sales of Prolia and Xgeva. It amounted to more than $6 billion, based on quarterly sales reported through the manufacturer.
About AVT03 (denosumab) AVT03 is a human monoclonal antibody and a biosimilar candidate for Prolia® and Xgeva® (denosumab). Denosumab targets and binds with maximum affinity and specificity to the membrane protein of the RANK ligand, avoiding the RANK/RANK ligand interaction. resulting in relief in the number and function of osteoclasts, reducing bone resorption and cancer-induced bone destruction [1]. AVT03 is an investigational product and has not obtained regulatory approval in any country. Biosimilarity has not been demonstrated through regulatory governance and is not claimed.
[1] https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/Prolia/prolia_pi.pdf
Prolia and Xgeva are registered by Amgen Inc.
About AlvotechAlvotech is a biotechnology company founded by Robert Wessman and focused solely on the development and production of biosimilar medicines for patients around the world. Alvotech seeks to become a global leader in biosimilars by offering high-quality, cost-effective products and services, made possible through fully incorporated technology and extensive in-house capabilities. Alvotech’s existing portfolio includes eight disclosed biosimilar applicants intended for the treatment of autoimmune diseases, eye disorders, osteoporosis, respiratory diseases and cancer. Alvotech has formed a network of strategic business partnerships to deliver global success and leverage local expertise in markets such as the United States, Europe, Japan, China and other Asian countries and major parts of South America, Africa and the Middle East. Alvotech’s commercial components are Teva Pharmaceuticals, a US subsidiary of Teva Pharmaceutical Industries Ltd. (USA), STADA Arzneimittel AG (EU), Fuji Pharma Co. , Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia). and New Zealand), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co. , Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co. , Ltd. (Thailand, Vietnam, Philippines and South Korea). Each business component covers a unique set of products and territories. Unless otherwise indicated, Alvotech disclaims all responsibility for the content of periodic documents, disclosures and other reports made through its components. For more information, visit www. alvotech. com. None of the data on Alvotech’s online page will be considered part of this press release.
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