Business Wire

Alvotech Initiates Clinical Studies for AVT04, a Proposed Biosimilar to Stelara® (Ustekinumab)

Share

Alvotech, the Iceland-based biosimilar company, today announced that the first patient has been dosed in the comparative, confirmatory efficacy and safety clinical study (AVT04-GL-301) for AVT04, Alvotech‘s proposed biosimilar to the reference product Stelara®. The objective of the study is to demonstrate therapeutic equivalence between AVT04 and Stelara® in terms of safety, efficacy and immunogenicity in patients with moderate-to-severe chronic plaque psoriasis.

The AVT04-GL-301 study is being conducted in five countries in Central and Eastern Europe and it is expected that approximately 530 patients will be enrolled in the study.

In parallel, Alvotech is also conducting a PK similarity study (AVT04-GL-101) to demonstrate equivalent PK endpoints between the proposed biosimilar and the reference product Stelara. The AVT04-GL-101 study, that is also assessing safety and tolerability, is currently ongoing in Australia and New Zealand and is expected to enroll 294 healthy adult volunteers.

Ustekinumab, which is among the highest selling pharmaceutical products in the world, had worldwide sales of $7.7 bn in 2020.

AVT04 is the second proposed biosimilar product from Alvotech entering clinical studies, the first being AVT02, a proposed biosimilar to Humira®. Alvotech is the only known company that has both developed a biosimilar candidate for the high-concentration Humira® and is executing a switching study to support its approval as an interchangeable product.

Róbert Wessman, founder and Chairman of Alvotech, commented:

”As a founder, I am extremely proud to see us enter the second proposed biosimilar product into clinical trials. This brings us closer to our mission to expand patient access to high quality biosimilars at an affordable price.”

Mark Levick, CEO of Alvotech, added:

“We are pleased to have reached this important milestone where the first subjects are being enrolled in clinical trials for AVT04, and we look forward to continuing with recruitment and patient follow-up.

Additionally, the initiation of this clinical program, with two studies running in parallel, reinforces our commitment to improving the efficiency of the clinical development, with the ultimate goal of improving the lives of patients suffering from serious chronic or life-threatening diseases, through faster access to high-quality biosimilars.”

About Alvotech:

Alvotech is a multinational biopharmaceutical company focused on the development and manufacture of high quality biosimilars for global markets. We are specialists in biotechnology, seeking to be a global leader in the biosimilar space by delivering high quality, cost-competitive products and services to our partners and to patients worldwide. Our fully integrated approach, with high-quality in-house competencies throughout the value chain, enables the accelerated development of biosimilar products. Alvotech’s shareholder base includes, among others, Aztiq Pharma, led by founder and Chairman Mr. Robert Wessman, Fuji Pharma from Japan, YAS Holdings form Abu Dhabi, Shinhan from Korea, Baxter Healthcare SA from the US, ATHOS (Strüngmann Family Office) from Germany and CVC Capital Partners and Temasek from Singapore through their participation in Alvogen.

Alvotech‘s initial pipeline contains several monoclonal-antibody and fusion-protein biosimilar candidates aimed at treating autoimmunity, oncology and inflammatory conditions to improve quality of life for patients around the world. For more information, please visit our website, www.alvotech.com or follow us on LinkedIn, Twitter and Facebook.

About AVT04 and AVT02:

AVT04 is a monoclonal antibody (mAb) and a proposed biosimilar to STELARA® (ustekinumab). AVT04 is an investigational compound and has not received regulatory approval in any country. Biosimilarity has not yet been established by regulatory authorities and is not yet claimed.

AVT02 is a monoclonal antibody (mAb) and a proposed biosimilar to HUMIRA® (adalimumab). AVT02 is an investigational compound and has not received regulatory approval in any country. Biosimilarity has not yet been established by regulatory authorities and is not yet claimed.

Forward Looking Statement

Except for historical information contained herein, the matters set forth in this press release are forward looking statements that are subject to risks and uncertainties that could cause actual results to differ materially. These forward-looking statements are not based on historical facts but rather on our expectations regarding future growth, results of operations, performance, future capital and other expenditures, competitive advantages, business prospects and opportunities. Statements in this press release about our future plans and intentions, results, level of activities, performance, goals or achievements or other future events constitute forward looking statements. There are a number of factors which could cause actual results or developments to differ materially from those expressed or implied by such forward-looking statements. Any of the assumptions underlying forward-looking statements could prove inaccurate or incorrect and therefore any results contemplated in forward-looking statements may not actually be achieved. Nothing contained in these slides and/or the press release of them should be construed as a profit forecast or profit estimate. Wherever possible, words such as “anticipate”, “believe”, “expect”, “may”, “could”, “will”, “potential”, “intend”, “estimate”, “should”, “plan”, “predict”, or the negative or other variations of statements reflect management’s current beliefs and assumptions and are based on the information currently available to our management. Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Alvotech
Corporate Communications
Elisabet Hjaltadottir
E-mail: Alvotech.media@alvotech.com

About Business Wire

Business Wire
Business Wire



Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Personalis, Inc. Publishes New Data Demonstrating a Novel Composite Biomarker NEOPS™ for Predicting Response to Cancer Immunotherapy in Late-Stage Melanoma Patients2.8.2021 22:05:00 CEST | Press release

Personalis, Inc. (Nasdaq: PSNL), a leader in advanced translational genomics and diagnostics for cancer, today announced the publication of its study "Prediction of immunotherapy response in melanoma through combined modeling of neoantigen burden and immune-related resistance mechanisms,"(1) in Clinical Cancer Research, a journal published by the American Association for Cancer Research. The study details the development of the Personalis Neoantigen Presentation Score (NEOPS™), a novel composite biomarker for predicting response to cancer immunotherapy. Enabled by comprehensive tumor immunogenomic profiling from the Personalis NeXT Platform, NEOPS simultaneously models both neoantigen burden and immune-related resistance mechanisms to better predict immunotherapy response in a cohort of late-stage melanoma patients. In this study, NEOPS was more strongly predictive of therapy response than other standard single analyte and investigational biomarkers tested, including tumor mutational b

The Consortium Welcomes Playtech’s Confirmed Recommendation for Its Binding Agreement to Acquire Finalto and Urges Investors to Vote in Favour at the Playtech Adjourned General Meeting on 18 August 20212.8.2021 19:41:00 CEST | Press release

Finalto S.P.V. Ltd, the consortium led by Barinboim Group and backed by Leumi Partners Limited and Menora Mivtachim Group, together with key members of the Finalto Business' management team (together the "Consortium"), welcomes the announcement by Playtech plc (“Playtech”) confirming its recommendation that shareholders vote in favour of the Consortium’s binding agreement for Finalto Group (“Finalto) (the “Binding Agreement”). Playtech announced today that following its engagement with Gopher Investments (“Gopher”) over the past three weeks, it has not received responses from Gopher to a number of its questions and therefore “Playtech has not yet been able to achieve the necessary clarity on Gopher's ultimate ownership and funding structure, source of funds or ability to obtain the required regulatory clearances”. Shareholders should ask why Gopher continues to hide and should also be suspicious of Gopher’s credibility, particularly given that disclosure is crucial when buying a highly

Lenovo Climbs 65 Places to Record #159 On ‘FORTUNE Global 500’ List2.8.2021 17:09:00 CEST | Press release

After achieving historical 2021 fiscal year results, Lenovo has been ranked #159 on FORTUNE’s annual Global 500 List and in the top 20 (#15) of all Technology sector companies cited in the List. Lenovo jumped 65 spots this year to an all-time high ranking due to its record financial results, which saw the Group surge past the US$60 billion revenue mark, and adding more than US$10 billion from the previous fiscal year as all core businesses grew. The Fortune Global 500 is the annual ranking of the largest 500 corporations in the world as measured by total revenue. Together, companies on The Global 500 generated US$31.7 trillion in revenue and US$1.6 trillion in profits in 2020, employ 69.7 million people worldwide and are represented by 31 countries. Lenovo’s updated ranking reflects the company’s clear strategy, product innovation, operational excellence, and global/local footprint within the past year. These results reinforced the company’s resilience and ability to achieve balanced,

From Panasonic i-PRO Sensing Solutions to “i-PRO”, Renewing Its Company Name From April 20222.8.2021 17:00:00 CEST | Press release

Panasonic i-PRO Sensing Solutions Co., Ltd. will renew its company name to "i-PRO Co., Ltd." on April 1, 2022. Our company was established in October 2019 as a business separation from Panasonic Corporation, and we have incorporated the network camera brand "i-PRO" into our company name. With the new brand "i-PRO", we have been developing and delivering products that incorporate various innovations to our customers, with "Extend human senses through technology, to capture moments of truth so the front-line professionals can act." as our brand purpose for our existence in society. With our global headquarters located in Japan, we will continue our daily efforts to innovate and develop a range of products under the global brand name "i-PRO", which will be launched in markets around the world. In advance of it, i-PRO EMEA B.V. will be headquartered in Amsterdam and start operations as of October 1st, 2021, in the transition of its European Security and Industrial Medical Vision (IMV) busi

Technology Innovation Institute Appoints Eminent Technologist Dr Ray O. Johnson as CEO2.8.2021 15:54:00 CEST | Press release

Technology Innovation Institute (TII), the applied research pillar of the Advanced Technology Research Council (ATRC), the overarching advanced technology body in Abu Dhabi responsible for driving research and development for transformative technology outcomes, today announced the appointment of veteran technologist and entrepreneur Dr Ray O. Johnson as Chief Executive Officer. Dr Johnson will work on shaping the strategic direction of the Institute and lead the execution of its growth strategies to achieve operational excellence. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210802005462/en/ Dr Ray O. Johnson, Chief Executive Officer, Technology Innovation Institute (Photo: AETOSWire) Prior to joining TII, Dr Johnson was an Operating Partner at Bessemer Venture Partners, a top-tier American venture capital company that has been part of 130 IPOs in the last 50 years, and before that, he was the Corporate Senior Vice Preside

Esri Signs Goodwill Protocol with Atlas University2.8.2021 14:00:00 CEST | Press release

Esri, the global leader in location intelligence, today announced it signed a protocol to extend cooperation with Atlas University in Istanbul, Turkey, through its distributor, Esri Turkey. In doing so, Atlas University seeks to enable students to learn and develop the application of geospatial technology in all their activities. Atlas University was established in 2018, and it aims to use geographic information system (GIS) solutions in its related units, especially in the Faculty of Engineering and Natural Sciences. For this purpose, the Continuous Education Center (AtlasSEM) in the university will also serve as a GIS base. This center will be allocated to provide training on GIS, using Esri technology, and courses will be included in the online training contents offered by AtlasSEM. Additionally, the institution will jointly conduct research and development activities in the field of GIS. Evaluating the protocol, the president of the Board of Trustees of Atlas University, Dr. Yusuf

H.I.G. Capital to Acquire Quick Restaurants S.A.2.8.2021 13:08:00 CEST | Press release

H.I.G. Capital, LLC (“H.I.G.”), a leading global alternative investment firm with $45 billion of equity capital under management, is pleased to announce that an affiliate has entered into a definitive agreement to acquire Quick Restaurants S.A. (the “Company” or “Quick”) from Burger King France. The transaction is expected to be completed before the end of the year, following regulatory approval. Established in 1971, Quick is one of the leading burger fast food chains. Present in France since 1980, Quick serves more than 36 million meals per year from a network of 107 restaurants. Olivier Boyadjian, Managing Director at H.I.G. Capital commented, “H.I.G.’s investment will support Quick’s management team in its transition to an independent company and further accelerate its expansion with an objective of doubling the size of its network in the coming years.” About H.I.G. Capital H.I.G. is a leading global private equity and alternative assets investment firm with $45 billion of equity ca

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom