SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the Month of May 2023
Commission File Number: 001-41421
(Translation of registrants name into English)
9, Rue de Bitbourg,
Grand Duchy of Luxembourg
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
☒ Form 20-F ☐ Form 40-F
INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
Incorporation by reference
This Report on Form 6-K (this Report) of Alvotech (the Company), including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934 (the Exchange Act) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act.
On May 4, 2023, Alvotech announced the initiation of a confirmatory patient study for AVT05, a proposed biosimilar for Simponi® and Simponi Aria® (golimumab). A copy of the announcement is furnished as Exhibit 99.1 to this Report on Form 6-K.
|99.1||Press Release dated May 4, 2023.|
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|Date: May 4, 2023||By:||/s/ Tanya Zharov|
|Name: Tanya Zharov|
|Title: General Counsel|
Alvotech Initiates Confirmatory Patient Study for AVT05,
a Proposed Biosimilar for Simponi® and Simponi Aria®
The clinical study will compare AVT05 and Simponi® in patients with moderate to severe rheumatoid arthritis
REYKJAVIK, ICELAND (May 4, 2023) Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today the initiation of Alvotechs confirmatory patient study for AVT05, a biosimilar candidate to Simponi® and Simponi Aria® (golimumab). The objective of the clinical study is to compare the efficacy, safety, and immunogenicity of AVT05 and Simponi® in adult patients with moderate to severe rheumatoid arthritis.
It is a pleasure to be able to mark another clinical milestone in our biosimilars development pipeline, said Joseph McClellan, Chief Scientific Officer. Alvotechs platform approach allows us to diversify and develop multiple product candidates in parallel. This is part of our strong commitment to improve patient lives by expanding access to affordable biologics globally.
The AVT05 confirmatory patient study (https://clinicaltrials.gov/ct2/show/NCT05842213) is a randomized, double-blind, 2-arm multicenter study comparing the efficacy, safety, and immunogenicity of subcutaneous AVT05 and EU-approved Simponi in patients with moderate to severe rheumatoid arthritis. The primary outcome measure will be to demonstrate comparative efficacy of AVT05 with Simponi at week 16 based on change from baseline on a standardized Disease Activity Standard score (DAS28-CRP) which assesses the severity of rheumatoid arthritis using clinical and laboratory data. In January 2023 Alvotech announced the initiation of a pharmacokinetic study for AVT05.
In the twelve months up to April 2023, combined net revenues worldwide from sales of Simponi and Simponi Aria were over $2.1 billion, based on reported sales by the manufacturer of the reference product .
Source: Johnson & Johnson quarterly reports.
AVT05 is a biosimilar candidate for Simponi and Simponi Aria (golimumab). Golimumab is a monoclonal antibody that inhibits tumor necrosis factor alpha (TNF alpha), a cytokine protein in the body. Elevated TNF alpha levels have been implicated in several chronic inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. AVT05 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.
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102 Reykjavĺk, Iceland
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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. Alvotechs 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. Alvotechs commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU and select other territories), 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.
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, Alvotechs 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 satisfactory responses to the FDAs inspection findings and resolution of other deficiencies conveyed following the inspection of Alvotechs manufacturing site, the potential approval and commercial launch of its product candidates, the timing of regulatory approval and market launches, and the estimated size of the total addressable market of Alvotechs pipeline products. In some cases, you can identify 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 Alvotechs control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (1) the outcome of any
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102 Reykjavĺk, Iceland
|Phone +354 422 4500|| |
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 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) Alvotechs estimates of expenses and profitability; (6) Alvotechs 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 respond to inspection findings and resolve deficiencies to the satisfaction of the regulators; (9) the ability of Alvotech or its partners to enroll and retain patients in clinical studies; (10) the ability of Alvotech or its partners to gain approval from regulators for planned clinical studies, study plans or sites; (11) the ability of Alvotechs partners to conduct, supervise and monitor existing and potential future clinical studies, which may impact development timelines and plans; (12) Alvotechs ability to obtain and maintain regulatory approval or authorizations of its products, including the timing or likelihood of expansion into additional markets or geographies; (13) the success of Alvotechs current and future collaborations, joint ventures, partnerships or licensing arrangements; (14) Alvotechs ability, and that of its commercial partners, to execute their commercialization strategy for approved products; (15) Alvotechs ability to manufacture sufficient commercial supply of its approved products; (16) the outcome of ongoing and future litigation regarding Alvotechs products and product candidates; (17) the potential impact of the ongoing COVID-19 pandemic on the FDAs review timelines, including its ability to complete timely inspection of manufacturing sites; (18) 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 Companys business, financial position, strategy and anticipated milestones; and (19) 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 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
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102 Reykjavĺk, Iceland
|Phone +354 422 4500|| |