Pressemitteilung: Alvotech und STADA erweitern den Zugang zum Adalimumab-Biosimilar in Europa
Ein Dokument
Alvotech und STADA erweitern den Zugang zum Adalimumab-Biosimilar in Europa
- Adalimumab wird in Belgien, Bulgarien, Kroatien, der Tschechischen Republik, Lettland, Rumänien und Slowenien eingeführt und erhöht die Verfügbarkeit von hochkonzentriertem, Zitrat freiem Adalimumab in Europa
- Im Anschluss an die erste Einführung in neun Ländern: Österreich, Estland, Finnland, Frankreich, Deutschland, Litauen, Slowakei, Schweden und Schweiz
- Adalimumab ist das erste eingeführte Produkt, für das Alvotech und STADA im November 2019 eine exklusive strategische Partnerschaft angekündigt haben, die Biosimilar-Kandidaten in den Indikationsgebieten Immunologie, Onkologie und Augenheilkunde umfasst
Reykjavik; Bad Vilbel – 07. Dezember 2022 – Alvotech (NASDAQ: ALVO) und STADA tragen zur Verfügbarkeit von hochwertigen biologischen Behandlungen in Europa bei, indem sie ihre hochkonzentrierte, niedrigvolumige, Zitrat-freie Formulierung von Adalimumab in mehreren europäischen Ländern auf den Markt bringen.
Im Rahmen einer strategischen Partnerschaft liefert Alvotech an STADA Adalimumab Autoinjektoren und vorgefüllte Spritzen mit Arzneimittel und Wirkstoff, die in der vertikal integrierten europäischen Anlage in Reykjavik, Island, hergestellt werden. Nach ersten Markteinführungen seit Juni 2022 vermarktet STADA das Produkt nun über seine lokalen Tochtergesellschaften in sieben weiteren Ländern: Belgien, Bulgarien, Kroatien, Tschechische Republik, Lettland, Rumänien und Slowenien. STADA unterstützt die Markteinführung von Adalimumab in den einzelnen nationalen Märkten durch maßgeschneiderte Aufklärungsmaterialien und spezielle Unterstützungsprogramme für Patienten.
"Für Patienten in ganz Europa besteht ein erheblicher, ungedeckter Bedarf an biologischen Behandlungen für Autoimmunerkrankungen, einschließlich Adalimumab", erklärte Bryan Kim, Head Global Specialty Care, EVP, bei STADA. "Die Einführung in weiteren europäischen Ländern ist ein Beleg für unser Engagement, den Zugang von Patienten zu wichtigen Therapien zu verbessern. Wir freuen uns auf die Zusammenarbeit mit Alvotech, um Patienten und ihren Betreuern hochwertige Biosimilars zur Verfügung zu stellen."
Anil Okay, Chief Commercial Officer von Alvotech, ergänzt: "Wir sind sehr zufrieden mit der Annahme von Adalimumab auf dem europäischen Markt und glauben, dass das patienten-freundliche Design des Autoinjektors, das wir eingeführt haben, den kommerziellen Erfolg unterstützt. Die Partnerschaft mit STADA wird den Zugang zu kosteneffizienten Biologika in innerhalb Europas im Einklang mit unserer gemeinsamen Vision weiter ausbauen."
Im November 2019 gaben STADA und Alvotech eine exklusive Partnerschaftsvereinbarung bekannt, die Biosimilar-Kandidaten für die Indikationen Immunologie, Onkologie und Augenheilkunde umfasst. Alvotech ist in erster Linie für die Entwicklung und Herstellung verantwortlich, während STADA die Vermarktung übernimmt.
Im November 2021 erhielt STADA von der Europäischen Kommission die Marktzulassung fürein hochkonzentriertes Adalimumab, in den 27 EU-Mitgliedstaaten sowie Island, Liechtenstein und Norwegen. Das Biosimilar wurde auch in der Schweiz und im Vereinigten Königreich zugelassen.
Über die STADA Arzneimittel AG
Die STADA Arzneimittel AG hat ihren Sitz im hessischen Bad Vilbel. Das Unternehmen setzt auf eine Drei-Säulen-Strategie bestehend aus Generika, Spezialpharmazeutika und verschreibungsfreie Consumer Healthcare Produkte. Weltweit vertreibt die STADA Arzneimittel AG ihre Produkte in rund 120 Ländern. Im Geschäftsjahr 2021 erzielte STADA einen Konzernumsatz von 3.249,5 Millionen Euro und ein Ergebnis vor Zinsen, Steuern und Abschreibungen (EBITDA) von 776,5 Millionen Euro. Zum 31. Dezember 2021 beschäftigte STADA weltweit 12.520 Mitarbeiter.
About Alvotech
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. 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. 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, the potential approval and commercial launch of its product candidates, the timing of regulatory approvals and market launches, the estimated size of the total addressable market of Alvotech’s pipeline products, and the commercial success of Hukyndra in Europe and other parts of the world. 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 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) 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) Alvotech’s estimates of 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 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 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; (13) Alvotech’s ability, and that of its commercial partners, to execute their commercialization strategy for approved products; (14) Alvotech’s ability to manufacture sufficient commercial supply of its approved products; (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; (17) 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 Company’s business, financial position, strategy and anticipated milestones; and (18) 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.
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Oder besuchen Sie uns im Internet unter www.stada.de/presse
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Oder besuchen Sie uns im Internet unter www.stada.de/investor-relations