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
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

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

ABP Publishing Exceeded 500 Audiobooks in Its Catalogue, and Sales Are Forecasted to Grow 30% in 202129.7.2021 10:30:00 CEST | Press release

ABP Publishing announces its audiobook catalogue exceeded 500 titles. The European publisher go on to say that they are forecasting a 100% increase in titles (1000 titles) by 2024. In addition, a 30% increase in total sales is predicted before the end of 2021, continuing a five-year trend of growth. There are plans to publish 17% more titles in 2022 and continue growing the catalogue to meet their 100% increase target by 2024. To meet these targets, ABP Publishing plans to expand its presence gradually in markets it entered recently, such as Turkey, Japan, Korea, and Spain. Additionally, it will continue to work with local authors, particularly in Germany and France. "For the last three years, ABP Publishing has shown solid growth in sales and production. It means that we managed to create an effective system of acquiring rights to high-potential books and externalizing them into good quality audiobooks. I believe the combination will help us achieve our main aim during the next three

Henley & Partners: Investment Migration: “We Need More, Not Less Immigration of People Who Contribute Positively to Society”29.7.2021 10:00:00 CEST | Press release

Henley & Partners Chairman Dr. Christian H. Kaelin says the significant worldwide expansion of investment migration, by which affluent individuals invest in other countries to acquire residence or citizenship, is simply unstoppable. Speaking at The World Ahead Gala Dinnerhosted by The Economist in Athens last week, Dr. Kaelin stated that all over the world countries have realized the importance of residence and citizenship to attract much-needed foreign direct investment, debt-free capital, talented entrepreneurs, and experienced investors. Dr. Kaelin, who is widely considered the pioneer and one of the world’s foremost experts in investment migration, shared the stage with Ireland’s Minister for Finance and President of the Eurogroup, Paschal Donohoe, and Greece’s Minister of Finance, Christos Staikouras, at the annual event to discuss the year ahead with government and business leaders. Further accelerated by the need to alleviate the financial distress following the Covid-19 pandemi

Katherine Alexakis Appointed to Chief Financial Officer of euNetworks29.7.2021 10:00:00 CEST | Press release

euNetworks Group Limited (“euNetworks”), a Western European bandwidth infrastructure company, today announced the appointment of Katherine Alexakis to the leadership team, taking up the role of Chief Financial Officer. This appointment is effective 6 September 2021, at which time Katherine will also join the Board of Directors as an Executive Director. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210729005060/en/ Brady Rafuse, CEO of euNetworks (Photo: Business Wire) Katherine joins euNetworks after 15 years working at Goldman Sachs International in London, where she held several roles across the European Equities business. She most recently served as a Managing Director within European Equity Research, sitting on the European Investment Review Committee and leading the European Tactical Research Group. Katherine was also responsible for merchandising the research product across the Securities division. Previously, Katheri

Onera raises €10.5M in Series B funding29.7.2021 10:00:00 CEST | Press release

Onera Health, a leader in sleep diagnostic and monitoring solutions, closed the Series B funding round today, which brought the total funding raised to date above the €24M mark. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210729005036/en/ The model is wearing the head and chest patch of Onera STS innovative PSG system. (Photo: Business Wire) Led by Innovation Industries in close collaboration with Invest-NL and with existing investors Jazz Pharmaceuticals, imec.xpand, BOM and 15th Rock, the company intends to use the funds to execute clinical studies and further commercialize its sleep diagnostics and monitoring products in Europe and the United States. Onera has recently obtained the CE mark for its first product, an innovative polysomnography (PSG) system that brings the gold-standard quality of a hospital diagnostic system directly to a user’s home. “We’re going to leverage the funding to conduct progressively larger s

Prokarium Appoints Uz Stammberger as Chief Medical Officer to Drive Clinical Development in Oncology29.7.2021 10:00:00 CEST | Press release

Prokarium, a biopharmaceutical company pioneering the oncology field of microbial immunotherapy, today announced the appointment of Uz Stammberger, MD, as Chief Medical Officer. In the role, Dr. Stammberger will lead the advancement of Prokarium’s oncology pipeline into the clinic. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210729005044/en/ Uz Stammberger, MD, Chief Medical Officer of Prokarium (Photo: Business Wire) “Uz brings extensive clinical experience to Prokarium’s team having spent more than two decades in oncology drug development and research,” said Kristen Albright, PharmD, Chief Executive Officer of Prokarium. “We are thrilled to welcome Uz onboard as we expand our clinical portfolio into oncology, and I look forward to working together on the development of our next generation immuno-oncology pipeline.” “Prokarium’s unique technology based on live, attenuated bacteria is a promising and powerful strategy for

BehavioSec Expands Portfolio and Opens Market Access with Another Industry First29.7.2021 09:00:00 CEST | Press release

BehavioSec, industry pioneer and technology leader for behavioral biometrics and continuous authentication, today announced that it has extended its patented technology and BehavioSense platform into a SOC/ISO compliant, hosted-version and a cloud-native, SaaS version. These new versions will help more organizations meet compliance and cloud mandates, support frictionless multi-factor authentication (MFA), and gain access to the market’s most advanced behavioral biometrics technology – which until now – has only been employed within the world’s largest banks, e-Identity providers, and online retailers. According to the recent July release of the 2021 Gartner ® Market Guide for Online Fraud Detection, “The convergence between online fraud detection (OFD), identity proofing and authentication continues with many organizations applying OFD capabilities to mitigate risk in identity proofing and authentication events.” The report further adds, “Banks are becoming increasingly comfortable wi

SES Enters Multi-transponder Agreement with NewSpace India Limited via SES-829.7.2021 08:58:00 CEST | Press release

SES announced today that it had entered into a multi-transponder agreement for its SES-8 satellite with NewSpace India Limited (NSIL), a Central Public Sector Enterprise (CPSE) under Department of Space (DoS) based in Bengaluru, India. The nine-transponder capacity agreement on SES-8 at 95 degrees East will be used to support India’s thriving direct-to-home (DTH) market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210728006179/en/ SES Enters Multi-transponder Agreement with NewSpace India Limited via SES-8 (Photo: Business Wire) Deepak Mathur, Executive Vice President of Sales at SES Video, said, “Satellite TV and the programmes it brings hold a very important role for Indian TV viewers. We are honoured to be able to provide continued support and satellite capacity needed to support DTH operations in the country in collaboration with NSIL." Follow us on: Read our Blogs > Visit the Media Gallery > About SES SES has a bold