Full Press Release Details
Confirms Acceptance of Application for AVT04, a Proposed Biosimilar to Stelara (ustekinumab)
Reykjavik, Iceland & Bad Vilbel, Germany
February 9, 2023 Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and global pharmaceutical company STADA
Arzneimittel (STADA) today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT04, Alvotech s proposed biosimilar to Stelara
(ustekinumab). The companies anticipate that the EMA could recommend approving a marketing authorization for AVT04 as soon as in the second half of 2023.
We are pleased to be able to move closer to making AVT04 available to patients in Europe, said Joseph McClellan, Chief Scientific Officer of
Alvotech. Our goal is to meet an increasing need for broader access to affordable biologic medicines and Alvotech s end-to-end biosimilars platform is
designed to support the development and manufacture of multiple products simultaneously.
The EMA s acceptance for filing marks a key
milestone in making an additional treatment option for inflammatory conditions available to patients and physicians in Europe, commented STADA s Head of Specialty, Bryan Kim. Authorization for ustekinumab would add to STADA s
extensive range of six approved biosimilars in Europe, a portfolio that includes a high-concentration, citrate-free of adalimumab brought to market through our strategic partnership with Alvotech.
Executive Board: Peter Goldschmidt (CEO) / Simone Berger / Miguel Pagan Fernandez / Boris D bler
Chairman of the Supervisory Board: Dr. G nter von Au
In November 2019, Alvotech and STADA announced a strategic partnership to commercialize eight biosimilar candidates
developed by Alvotech in Europe. As of December 2022, the companies had launched marketing and sales of the first biosimilar in the partnership, high-concentration adalimumab, in 16 countries in Europe.
In May 2022, Alvotech announced that a confirmatory clinical, safety and efficacy study for AVT04 had met its primary endpoint, in demonstrating
therapeutic equivalence between Alvotech s biosimilar candidate and the reference product in patients with moderate to severe chronic plaque-type psoriasis. Earlier in May 2022, Alvotech also announced positive top-line results from a pharmacokinetic (PK) similarity study for AVT04.
About AVT04 (ustekinumab)
AVT04 is a monoclonal antibody and a biosimilar candidate to Stelara (ustekinumab). Ustekinumab binds
to two cytokines, IL-12 and IL-23, that are involved in inflammatory and immune responses [1]. AVT04 is an
investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.
About STADA Arzneimittel AG
STADA Arzneimittel AG is headquartered in Bad Vilbel, Germany. The company focuses on a three-pillar strategy consisting of generics, specialty pharma and non-prescription consumer healthcare products. Worldwide, STADA Arzneimittel AG sells its products in approximately 120 countries. In financial year 2021, STADA achieved group sales of EUR 3,249.5 million and
reported earnings before interest, taxes, depreciation and amortization (EBITDA) of EUR 776.5 million. As of 31 December 2021, STADA employed 12,520 people worldwide.
Executive Board: Peter Goldschmidt (CEO) / Simone Berger / Miguel Pagan Fernandez / Boris D bler
Chairman of the Supervisory Board: Dr. G nter von Au
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 contains eight 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), 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.
Forward Looking Statements
Certain statements in this
communication may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements generally relate to future events or the future financial
operating performance of Alvotech and may include, for example, Alvotech s expectations regarding competitive advantages, business prospects and opportunities including pipeline 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 commercial partnerships, including its partnership with STADA, potential milestone and royalty payments, the potential
approval and commercial launch of its product candidates, the timing of regulatory approvals and market launches, including in Europe, and the estimated size of the total addressable market of Alvotech s pipeline products, and the commercial
success of AVT04, in Europe and other parts of the world, Alvotech s ability to improve global access to affordable biologics, and the effect of biosimilars on inflationary pressures for healthcare systems. In some cases, you can identify
Executive Board: Peter Goldschmidt (CEO) / Simone Berger / Miguel Pagan Fernandez / Boris D bler
Chairman of the Supervisory Board: Dr. G nter von Au
forward-looking statements by terminology such as may , should , expect , intend ,
will , estimate , anticipate , believe , predict , potential , aim or continue , or the negatives of these terms or variations of them or similar terminology.
Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are
based upon estimates and assumptions that, while considered 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.
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) changes in applicable laws or regulations; (3) the possibility that Alvotech may be adversely affected by other economic, business, and/or competitive factors;
(4) Alvotech s estimates of expenses and profitability; (5) Alvotech s ability to develop, manufacture and commercialize the products and product candidates in its pipeline, including AVT04; (6) actions of regulatory authorities,
which may affect the initiation, timing and progress of clinical studies or future regulatory approvals or marketing authorizations; (7) the ability of Alvotech or its partners to respond to inspection findings and resolve deficiencies to the
satisfaction of the regulators; (8) the ability of Alvotech or its partners to enroll and retain patients in clinical studies; (9) the ability of Alvotech or its partners to gain approval from regulators 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 timelines and plans; (11) Alvotech s ability to obtain and
maintain regulatory approval or authorizations of its products, including AVT04, including the timing or likelihood of expansion into additional markets or geographies; (12) the success of Alvotech s current and future collaborations,
joint ventures, partnerships or licensing arrangements, including the partnership with STADA; (13) Alvotech s ability, and that of its commercial partners, to execute their commercialization strategy for approved products, including AVT04;
(14) Alvotech s ability to manufacture sufficient commercial supply of its approved products, including AVT04; (15) the outcome of ongoing and future litigation regarding Alvotech s products and product candidates; (16) 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; and (17) 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. Alvotech
Executive Board: Peter Goldschmidt (CEO) / Simone Berger / Miguel Pagan Fernandez / Boris D bler
Chairman of the Supervisory Board: Dr. G nter von Au
disclaims any and 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 from this communication and such liability is expressly disclaimed. The recipient agrees that it shall not seek to sue or otherwise hold Alvotech or any of its directors, officers, employees,
affiliates, agents, advisors, or representatives liable in any respect for the provision of this communication, the information contained in this communication, or the omission of any information from this communication.
Alvotech Investor Relations and Global
Benedikt Stefansson, Director
E-Mail: alvotech.ir[at]alvotech.com
STADA information for journalists:
Arzneimittel AG Media Relations
61118 Bad Vilbel Germany
Phone: +49 (0) 6101 603-165
Fax: +49 (0) 6101 603-215
E-Mail: press@stada.de
Or visit us on the Internet at www.stada.com/press
STADA information for capital market participants:
STADA Arzneimittel AG Investor & Creditor Relations
Phone: +49 (0) 6101 603-4689
Fax: +49 (0) 6101 603-215
Or visit us on the Internet at www.stada.com/investor-relations
Executive Board: Peter Goldschmidt (CEO) / Simone Berger / Miguel Pagan Fernandez / Boris D bler
Chairman of the Supervisory Board: Dr. G nter von Au