Alvotech

  • Alvotech will present two posters and will be featured in an Ignite Talk related to its switching study for ATV02

  • The switch study was conducted to investigate the pharmacokinetics, immunogenicity, efficacy and safety in patients undergoing repeated switches between Humira and AVT02

  • Alvotech is the only known company that has both developed a high concentration biosimilar candidate for Humira and performed a switch study to support interchangeability

REYKJAVIK, Iceland, Nov. 10, 2022 (GLOBE NEWSWIRE) — Alvotech (NASDAQ:ALVO), a global biotechnology company focused on developing and manufacturing biosimilar medicines for patients worldwide, today announced that she will present two posters and be featured in an Ignite Talk related to her switch study for ATV02 at the American College of Rheumatology (ACR) Convergence Conference, to be held in Philadelphia November 10-14, 2022.

Posters and Ignite Talk will provide details of data from Alvotech’s switch study for ATV02, a proposed high strength (100 mg/mL) citrate-free interchangeable biosimilar candidate for Humira® (adalimumab), conducted to study pharmacokinetics (PK), immunogenicity, efficacy and safety in patients undergoing repeated switching between Humira and AVT02.

Alvotech is the only known company that has both developed a high concentration biosimilar candidate for Humira and completed a switching study to support potential regulatory approval as an interchangeable product. Alvotech’s Biological License Application (BLA) for interchangeability between ATV02 and Humira® was accepted by the United States Food and Drug Administration (FDA) in February 2022 and is currently under review by the FDA.

Demonstrating interchangeability of biosimilars with originator products is key to supporting clinical practice by reducing healthcare costs and increasing patient access to biologic therapies. The biosimilarity of AVT02 with Humira was previously evaluated in a Pharmacokinetic study and confirmatory efficacy and safety studywhich supported the biosimilarity assessment of AVT02.

Alvotech’s poster titled “A clinical study designed to support a demonstration of interchangeability between AVT02 and Humira®” will be presented in the Virtual Poster Room on Saturday, November 12, 2022, from 1:00 p.m. to 3:00 p.m. Eastern Time (ET).

A second poster titled “Ex vivo comparative immunogenicity assessment (EVCIA) to determine relative immunogenicity in chronic plaque psoriasis in participants receiving Humira® or undergoing repeated switching between Humira and AVT02will be presented in the Virtual Poster Room on Sunday, November 13, 2022, from 9:00 a.m. to 10:00 a.m. ET.

On Monday, November 14, 2022, at 2:15 p.m. ET, Steve Feldman, MD, Ph.D., Professor of Dermatology, Wake Forest University School of Medicine, will give an Ignite talk on the Downtown Stage titled “A clinical study designed to support a demonstration of interchangeability between AVT02 and the reference adalimumab (Humira®).

Posters and presentation details will be available on the conference platform during the conference. More information on ACR’s Convergence 2022 conference is available here.

About AVT02 (adalimumab)
AVT02 is an approved monoclonal antibody and biosimilar to Humira® (adalimumab) in the EU, UK, Switzerland, Norway, Iceland, Lichtenstein (Hukyndra®) and Canada (Simlandi™). AVT02 files are under review in several countries, including the United States.

About Alvotech

Alvotech is a biotechnology company, founded by Robert Wessman, which is solely focused on developing and manufacturing biosimilar drugs for patients worldwide. Alvotech seeks to be a global leader in the biosimilars space by providing high-quality, cost-effective products and services enabled by a fully integrated approach and extensive in-house capabilities. Alvotech’s current pipeline contains eight biosimilar candidates for the treatment of autoimmune disorders, ocular disorders, osteoporosis, respiratory diseases and cancer. Alvotech has formed a network of strategic business partnerships to provide global reach and leverage local expertise in markets including the United States, Europe, Japan, China and other Asian countries and major parts from South America, Africa and the Middle East. Alvotech’s business partners include Teva Pharmaceuticals, a US subsidiary of Teva Pharmaceutical Industries Ltd. (USA), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), 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, Tutor and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines and South Korea). Each business partnership covers a unique set of product(s) and territories. Except as otherwise provided herein, Alvotech is not responsible for the content of periodic filings, disclosures and other reports made available by its partners. For more information, visit www.alvotech.com. None of the information on Alvotech’s website should be considered part of this press release.

Alvotech Forward-Looking Statements
Certain statements contained in this communication may be deemed “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1955, as amended. Forward-looking statements generally relate to future events or the future operating financial performance of Alvotech. For example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities, including ongoing product development, future plans and intentions, results, level of activities, performance, goals or achievements or other future events, regulatory review and interactions, the success of its business partnerships, the potential and timing of approvals and commercial launches of its product candidates, including for AVT02, estimated addressable market size Alvotech’s total pipeline products, and the potential of Alvotech’s pipeline products, including AVT02, to reduce healthcare costs and increase patient access to biological therapies. In some cases, you can identify forward-looking statements by words such as “may”, “should”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential”, “aim” or “continue”, or the negative terms of these terms or variations thereof or similar terminology. These forward-looking statements are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These forward-looking statements are based on estimates and assumptions which, although believed to be reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability and contingencies, many of which are beyond Alvotech’s control. Alvotech. Factors that could 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 brought against Alvotech or others as a result of the business combination between Alvotech Holdings SA, Oaktree Acquisition Corp. II and Alvotech; (2) the ability to maintain stock exchange listing standards; (3) changes in applicable laws or regulations; (4) the possibility that Alvotech may be adversely affected by other economic, business and/or competitive factors; (5) Estimates of Alvotech’s expenses and profitability; (6) Alvotech’s ability to develop, manufacture and commercialize the products and product candidates in its pipeline; (7) actions of regulatory authorities, which may affect the initiation, timing and progress of clinical studies or future regulatory approvals or marketing authorizations; (8) the ability of Alvotech or its partners to recruit and retain patients in clinical studies; (9) the ability of Alvotech or its partners to obtain regulatory approvals for planned clinical studies, study plans or sites; (10) the ability of Alvotech’s partners to conduct, supervise and monitor existing and potential future clinical studies, which may impact development schedules and plans; (11) Alvotech’s ability to obtain and maintain regulatory approvals or clearances for its products; (12) the success of Alvotech’s current and future collaborations, joint ventures, partnerships or license agreements; (13) Alvotech’s ability, and that of its business partners, to execute their strategy to commercialize approved products, including AVT02; (14) Alvotech’s ability to manufacture a sufficient commercial supply of its approved products, including AVT02; (15) the outcome of pending and future litigation regarding Alvotech’s products and product candidates; (16) the potential impact of the ongoing COVID-19 pandemic on FDA review timelines, including its ability to conduct timely inspection of manufacturing sites; and (17) other risks and uncertainties set forth in the sections titled “Risk Factors” and “Caution Regarding Forward-Looking Statements” in documents that Alvotech may from time to time file with or provide to the SEC. There may be additional risks that Alvotech is not currently aware of or that Alvotech currently believes to be immaterial that could also cause actual results to differ from those contained in the forward-looking statements. Nothing in this communication should be taken as a representation by anyone that the forward-looking statements set forth herein will be realized or that any of the results contemplated by 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 undertakes no obligation to update these forward-looking statements or to notify the recipient of any matter of which either becomes aware that may affect any matter referred to in this communication. Alvotech disclaims all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted in this communication and such liability is expressly disclaimed. The recipient agrees not to seek to sue or otherwise hold Alvotech or any of its directors, officers, employees, affiliates, agents, advisers or representatives liable in any respect for the provision of this communication, information contained in this communication, or the omission of any information from this communication.

CONTACTS

Alvotech Investor Relations and Global Communication
Benedikt Stefansson
alvotech.ir[at]alvotech.com