Alvotech Announces Positive Top-Line Results from a Pharmacokinetic Study for AVT03, a Proposed Biosimilar for Prolia® and Xgeva®
- Positive top-line results from a pharmacokinetic (PK) study for AVT03
- Assessment of pharmacokinetics, safety, and tolerability of AVT03 compared to Prolia®
- Meeting of primary endpoints in the study
- Prolia® and Xgeva® indicated for the treatment of bone disease
- Combined net revenues worldwide from sales of Prolia and Xgeva over US$6 billion in the last twelve months before September 30, 2023
- None.
Insights
The positive top-line results from Alvotech's pharmacokinetic study for AVT03, a biosimilar candidate to Prolia® and Xgeva®, have significant implications for the company's market position and for the biotech industry as a whole. Biosimilars are essentially generic versions of biologic drugs, offering the same efficacy at potentially reduced costs. Given that the combined net revenues for Prolia and Xgeva exceeded US$6 billion in the last fiscal year, the introduction of a biosimilar could lead to substantial market share acquisition for Alvotech.
From a financial perspective, the successful development of AVT03 could lead to increased revenue streams for Alvotech. The cost-effectiveness of biosimilars is a key factor in their adoption and payers, including insurance companies and government health programs, are likely to support their use to manage healthcare costs. However, it's important to note that the market uptake of biosimilars can be influenced by physician prescribing habits, patient acceptance and the legal landscape regarding patents and exclusivity periods.
The announcement by Alvotech could have a broader economic impact on healthcare spending, particularly in the area of bone disease treatment. With Prolia® and Xgeva® being major players in the osteoporosis and bone metastasis market, the introduction of a biosimilar could drive down drug prices through competition. This is particularly relevant as healthcare systems worldwide are grappling with rising drug costs.
For stakeholders, including patients and healthcare providers, the potential benefits of a new, more affordable treatment option are substantial. However, the long-term impact will depend on the biosimilar's adoption rate, which hinges on the confirmatory efficacy study's results, regulatory approvals and the subsequent commercial strategy employed by Alvotech. If the biosimilar is widely accepted, it could lead to decreased healthcare expenditures for bone disease treatments, which would be a significant benefit for both private and public healthcare payers.
The clinical implications of Alvotech's AVT03 reaching its primary endpoints in a pharmacokinetic study are noteworthy. The study's success indicates that AVT03 has a similar pharmacological profile to the reference drugs Prolia® and Xgeva®, which is a critical step in demonstrating biosimilarity. For a biosimilar to be approved, it must show that there is no clinically meaningful difference in safety, purity and potency compared to the original biologic.
It's also important to consider that biosimilars undergo a rigorous regulatory pathway that includes not only pharmacokinetic studies but also confirmatory efficacy trials. Alvotech's ongoing efficacy study and additional PK comparisons are essential to establish the full profile of AVT03. The outcome of these studies will be crucial for gaining regulatory approval and clinician trust, which in turn will influence the drug's market uptake and competitive landscape.
- The study, which assessed the pharmacokinetics, safety, and tolerability of AVT03 compared to Prolia® in healthy adult subjects, met its primary endpoints
- Prolia® and Xgeva® (denosumab) are indicated for the treatment of bone disease
REYKJAVIK, Iceland, Jan. 29, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today positive top-line results from a pharmacokinetic (PK) study for AVT03, a biosimilar candidate to Prolia® and Xgeva®, which both contain denosumab.
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. A confirmatory efficacy study for AVT03 in patients is currently underway, as well as a PK study comparing AVT03 to Xgeva® in healthy adult subjects.
“We are very pleased with the progress in our AVT03 program. This milestone, and recent positive top-line results from other clinical studies clearly demonstrate our capabilities and the excellence of Alvotech’s biosimilars development 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 presentation, is indicated for prevention of skeletal-related events such as pathological fractures in adults with advanced malignancies involving bone. It is also indicated for the treatment of giant cell tumor in bone. In the last twelve months before September 30, 2023, reported combined net revenues worldwide from sales of Prolia and Xgeva were over US
About AVT03 (denosumab)
AVT03 is a human monoclonal antibody and a biosimilar candidate to Prolia® and Xgeva® (denosumab). Denosumab targets and binds with high affinity and specificity to the RANK ligand membrane protein, preventing the RANK ligand/RANK interaction from occurring, resulting in reduced osteoclast numbers and function, thereby decreasing bone resorption and cancer-induced bone destruction [1]. AVT03 is an investigational product and has not received regulatory approval in any country. Biosimiliarity has not been established by regulatory authorities and is not claimed.
[1] https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/Prolia/prolia_pi.pdf
Use of trademarks
Prolia and Xgeva are registered trademarks of Amgen Inc.
About Alvotech
Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech’s current pipeline includes eight disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), 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 commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.
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Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (1) the outcome of any legal proceedings that may be instituted against Alvotech or others following the business combination between Alvotech Holdings S.A., Oaktree Acquisition Corp. II and Alvotech; (2) the ability to raise substantial additional funding, which may not be available on acceptable terms or at all; (3) the ability to maintain stock exchange listing standards; (4) changes in applicable laws or regulations; (5) the possibility that Alvotech may be adversely affected by other economic, business, and/or competitive factors; (6) Alvotech’s estimates of expenses and profitability; (7) Alvotech’s ability to develop, manufacture and commercialize the products and product candidates in its pipeline; (8) actions of regulatory authorities, which may affect the initiation, timing and progress of clinical studies or future regulatory approvals or marketing authorizations; (9) the ability of Alvotech or its partners to respond to inspection findings and resolve deficiencies to the satisfaction of the regulators; (10) the ability of Alvotech or its partners to enroll and retain patients in clinical studies; (11) the ability of Alvotech or its partners to gain approval from regulators for planned clinical studies, study plans or sites; (12) the ability of Alvotech’s partners to conduct, supervise and monitor existing and potential future clinical studies, which may impact development timelines and plans; (13) Alvotech’s ability to obtain and maintain regulatory approval or authorizations of its products, including the timing or likelihood of expansion into additional markets or geographies; (14) the success of Alvotech’s current and future collaborations, joint ventures, partnerships or licensing arrangements; (15) Alvotech’s ability, and that of its commercial partners, to execute their commercialization strategy for approved products; (16) Alvotech’s ability to manufacture sufficient commercial supply of its approved products; (17) the outcome of ongoing and future litigation regarding Alvotech’s products and product candidates; (18) the potential impact of the ongoing COVID-19 pandemic on the FDA’s review timelines, including its ability to complete timely inspection of manufacturing sites; (19) the impact of worsening macroeconomic conditions, including rising inflation and interest rates and general market conditions, war in Ukraine and global geopolitical tension, and the ongoing and evolving COVID-19 pandemic on the Company’s business, financial position, strategy and anticipated milestones; and (20) other risks and uncertainties set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time to time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. 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CONTACTS
Investor Relations and Media Contact:
Benedikt Stefansson, Senior Director
alvotech.ir@alvotech.com
FAQ
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