Alvotech Initiates Confirmatory Patient Study for AVT16, a Proposed Biosimilar to Entyvio®
Alvotech (NASDAQ: ALVO) has initiated a confirmatory patient study for AVT16, a proposed biosimilar to Entyvio® (vedolizumab). The study aims to demonstrate comparative efficacy, safety, and immunogenicity in participants aged 18-80 with moderate to severe active Ulcerative Colitis. Alvotech is one of only two companies known to have started such a study for an Entyvio biosimilar.
Entyvio, with global sales of about $5.4 billion in the last 12 months until June 30, 2024, is used to treat Ulcerative Colitis and Crohn's disease. The AVT16-GL-C01 study has a double-blind parallel design with two arms, comparing AVT16 to Entyvio.
Alvotech's growing pipeline includes biosimilars targeting autoimmune disease, eye disorders, bone disease, respiratory disease, and cancer. The company expects to file marketing applications for three biosimilar candidates in 2024, with AVT16 being one of six disclosed biosimilar programs in earlier development stages.
Alvotech (NASDAQ: ALVO) ha avviato uno studio confermativo sui pazienti per AVT16, un biosimilare proposto di Entyvio® (vedolizumab). Lo studio mira a dimostrare l'efficacia comparativa, la sicurezza e l'immunogenicità nei partecipanti di età compresa tra 18 e 80 anni con colite ulcerosa attiva da moderata a grave. Alvotech è una delle sole due aziende note ad aver iniziato uno studio di questo tipo per un biosimilare di Entyvio.
Entyvio, con vendite globali di circa $5.4 miliardi negli ultimi 12 mesi fino al 30 giugno 2024, è utilizzato per trattare la colite ulcerosa e la malattia di Crohn. Lo studio AVT16-GL-C01 ha un design parallelo in doppio cieco con due bracci, confrontando AVT16 con Entyvio.
Il crescente portafoglio di Alvotech include biosimilari mirati a malattie autoimmuni, disturbi oculari, malattie delle ossa, malattie respiratorie e cancro. L'azienda prevede di presentare domande di autorizzazione al commercio per tre candidati biosimilari nel 2024, con AVT16 che è uno dei sei programmi di biosimilari divulgati in stadi di sviluppo preliminare.
Alvotech (NASDAQ: ALVO) ha iniciado un estudio confirmatorio en pacientes para AVT16, un biosimilar propuesto para Entyvio® (vedolizumab). El estudio tiene como objetivo demostrar la eficacia comparativa, la seguridad y la inmunogenicidad en participantes de 18 a 80 años con colitis ulcerosa activa de moderada a grave. Alvotech es una de las únicas dos empresas conocidas por haber comenzado un estudio de este tipo para un biosimilar de Entyvio.
Entyvio, con ventas globales de aproximadamente $5.4 mil millones en los últimos 12 meses, hasta el 30 de junio de 2024, se utiliza para tratar la colitis ulcerosa y la enfermedad de Crohn. El estudio AVT16-GL-C01 tiene un diseño paralelo a doble ciego con dos grupos, comparando AVT16 con Entyvio.
El creciente portafolio de Alvotech incluye biosimilares dirigidos a enfermedades autoinmunes, trastornos oculares, enfermedades óseas, enfermedades respiratorias y cáncer. Se espera que la empresa presente solicitudes de marketing para tres candidatos a biosimilares en 2024, siendo AVT16 uno de los seis programas de biosimilares divulgados en etapas de desarrollo inicial.
Alvotech (NASDAQ: ALVO)는 제안된 Entyvio® (vedolizumab)에 대한 바이오시밀러인 AVT16의 확인 환자 연구를 시작했습니다. 이 연구는 중등도에서 중증의 활성 궤양성 대장염 환자(18세에서 80세)를 대상으로 비교 효능, 안전성 및 면역원성을 입증하는 것을 목표로 합니다. Alvotech는 Entyvio 바이오시밀러에 대해 이런 연구를 시작한 유일한 두 개 회사 중 하나입니다.
전 세계에서 약 $5.4억 달러의 매출을 올린 Entyvio는 궤양성 대장염과 크론병 치료에 사용됩니다. AVT16-GL-C01 연구는 Entyvio와 AVT16을 비교하는 두 가지 그룹을 갖는 이중 맹검 병행 설계로 진행됩니다.
Alvotech의 성장하는 파이프라인에는 자가면역 질환, 안과 질환, 뼈 질환, 호흡기 질환, 암을 목표로 하는 바이오시밀러가 포함되어 있습니다. 회사는 2024년에 세 가지 바이오시밀러 후보에 대한 마케팅 신청서를 제출할 것으로 예상하고 있으며, AVT16은 초기 개발 단계에서 공개된 여섯 개의 바이오시밀러 프로그램 중 하나입니다.
Alvotech (NASDAQ: ALVO) a lancé une étude confirmatoire sur des patients pour AVT16, un biosimilaire proposé à Entyvio® (vedolizumab). L'étude vise à démontrer l'efficacité comparative, la sécurité et l'immunogénicité chez des participants âgés de 18 à 80 ans atteints de colite ulcéreuse active modérée à sévère. Alvotech est l'une des deux seules entreprises connues à avoir lancé une telle étude pour un biosimilaire d'Entyvio.
Entyvio, avec des ventes mondiales d'environ $5,4 milliards au cours des 12 derniers mois jusqu'au 30 juin 2024, est utilisé pour traiter la colite ulcéreuse et la maladie de Crohn. L'étude AVT16-GL-C01 a un design parallèle en double aveugle avec deux bras, comparant AVT16 à Entyvio.
Le portefeuille croissant d'Alvotech comprend des biosimilaires visant des maladies auto-immunes, des troubles oculaires, des maladies osseuses, des maladies respiratoires et le cancer. L'entreprise prévoit de soumettre des demandes de commercialisation pour trois candidats biosimilaires en 2024, AVT16 étant l'un des six programmes de biosimilaires divulgués à des stades de développement précoce.
Alvotech (NASDAQ: ALVO) hat eine bestätigende Patientstudie für AVT16, ein vorgeschlagenes Biosimilars zu Entyvio® (vedolizumab), initiiert. Die Studie zielt darauf ab, die vergleichende Wirksamkeit, Sicherheit und Immunogenität bei Teilnehmern im Alter von 18 bis 80 Jahren mit moderater bis schwerer aktiver Colitis ulcerosa zu demonstrieren. Alvotech ist eines von nur zwei Unternehmen, das bekannt ist, solch eine Studie für ein Entyvio-Biosimilar gestartet zu haben.
Entyvio, mit globalen Umsätzen von etwa $5,4 Milliarden in den letzten 12 Monaten bis zum 30. Juni 2024, wird zur Behandlung von Colitis ulcerosa und Morbus Crohn eingesetzt. Die AVT16-GL-C01-Studie hat ein doppelblindes Paralleldesign mit zwei Armen, die AVT16 mit Entyvio vergleichen.
Das wachsende Portfolio von Alvotech umfasst Biosimilars, die auf Autoimmunerkrankungen, Augenkrankheiten, Knochenerkrankungen, Atemwegserkrankungen und Krebs abzielen. Das Unternehmen plant, 2024 Anträge auf Marktanmeldungen für drei Biosimilar-Kandidaten einzureichen, wobei AVT16 eines von sechs veröffentlichten Biosimilar-Programmen in früheren Entwicklungsphasen ist.
- Initiation of confirmatory patient study for AVT16, a biosimilar to Entyvio®
- Alvotech is one of only two companies known to have started such a study for an Entyvio biosimilar
- Entyvio's global sales reached $5.4 billion in the last 12 months
- Alvotech expects to file marketing applications for three biosimilar candidates in 2024
- Company has a growing pipeline of biosimilars targeting various diseases
- None.
Insights
The initiation of a confirmatory patient study for AVT16, Alvotech's biosimilar candidate to Entyvio® (vedolizumab), is a significant milestone in the company's pipeline development. This study aims to demonstrate comparable efficacy, safety and immunogenicity to the reference product in patients with moderate to severe active Ulcerative Colitis.
Key points to consider:
- Alvotech is among only two companies known to have initiated such a study for an Entyvio biosimilar, potentially positioning them as early movers in this space.
- The global Entyvio market is substantial, with sales of approximately
$5.4 billion in the last 12 months, indicating a large potential market for biosimilars. - Successful development of AVT16 could expand Alvotech's portfolio in the autoimmune disease segment, complementing their existing approved biosimilars for Humira® and Stelara®.
- The company's pipeline progression, with expected filings for three biosimilar candidates in 2024, suggests a robust development strategy that could drive future growth.
While the study initiation is promising, investors should be aware that the development and approval process for biosimilars is complex and time-consuming. The outcome of this study will be important in determining AVT16's potential market entry and Alvotech's future revenue streams in the inflammatory bowel disease market.
Alvotech's initiation of the AVT16 confirmatory patient study represents a strategic move to tap into the lucrative Entyvio® market, which generated approximately
- Market Opportunity: Entering the Entyvio biosimilar space could significantly expand Alvotech's revenue potential, given the large market size for inflammatory bowel disease treatments.
- Competitive Positioning: Being one of only two companies known to have initiated such a study gives Alvotech a potential first-mover advantage in this specific biosimilar market.
- Pipeline Strength: The addition of AVT16 to Alvotech's late-stage pipeline, alongside three expected biosimilar candidate filings in 2024, indicates a robust product development strategy that could drive future growth.
- Diversification: Expanding into new therapeutic areas diversifies Alvotech's portfolio, potentially reducing reliance on existing products and mitigating market risks.
While the news is positive for Alvotech's long-term prospects, investors should consider that biosimilar development involves significant R&D costs and regulatory hurdles. The full financial impact will depend on successful study outcomes, regulatory approvals and eventual market penetration, which are still some years away.
- Alvotech is one of two companies known to have initiated a global or multi-country confirmatory patient study for a biosimilar candidate to Entyvio®
- Sales of Entyvio (vedolizumab) were about
$5.4 billion globally in the last 12 months up to June 30, 2024 - Entyvio is indicated for the treatment of Ulcerative Colitis and Crohn’s disease
REYKJAVIK, Iceland, Sept. 25, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today the initiation of a confirmatory patient study for AVT16, a biosimilar candidate to Entyvio® (vedolizumab). The objective of the study is to demonstrate comparative efficacy, safety, and immunogenicity of AVT16 and Entyvio, in male and female participants 18-80 years old with moderate to severe active Ulcerative Colitis. Alvotech is one of two companies known to have initiated a global or multi-country confirmatory patient study for a biosimilar candidate to Entyvio.
Entyvio (vedolizumab) is indicated for the treatment of adult patients with moderate to severe Ulcerative Colitis, a disease causing inflammation and ulcers in the lining of the bowel, and moderate to severely active Crohn’s disease, a disease causing inflammation of the digestive tract. In the last twelve months until June 30, 2024, combined net revenues worldwide from sales of Entyvio were about US
“We are proud to be able to initiate the confirmatory patient study for AVT16, adding another important biosimilar candidate in clinical development to our pipeline. Alvotech’s growing pipeline and portfolio of marketed biosimilars, leveraging our dedicated comprehensive R&D and manufacturing platform, demonstrates our commitment to improving people’s lives globally by increasing access to cost-effective biologic medicines,” said Joseph McClellan, Chief Science Officer of Alvotech.
The AVT16-GL-C01 multicenter study has a double-blind parallel design with 2 arms. Participants will receive either AVT16 or Entyvio, and all participants will be followed to determine efficacy of the treatment using a standardized score for Ulcerative Colitis disease activity.
Alvotech’s current biosimilars portfolio targets autoimmune disease, eye disorders, bone disease, respiratory disease, and cancer. Two biosimilars, to Humira® (adalimumab) and Stelara® (ustekinumab) are already approved and marketed in multiple global markets. Alvotech expects to file marketing applications for three biosimilar candidates in the course of 2024, while AVT16 is one of six disclosed biosimilar programs in earlier stages of development.
About AVT16
AVT16 is a human monoclonal antibody and a biosimilar candidate to Entyvio® (vedolizumab). Vedolizumab targets and binds specifically to the alpha-4-beta-7 protein, which is preferentially expressed on T helper lymphocytes (white blood cells) which migrate into the gastrointestinal tract and cause inflammation characteristic of Ulcerative Colitis and Chron’s disease [2]. AVT16 is an investigational product and has not received regulatory approval in any country. Biosimiliarity has not been established by regulatory authorities and is not claimed.
About AVT02 (adalimumab)
AVT02 is a monoclonal antibody and has been approved as a biosimilar to Humira® (adalimumab) in over 50 countries globally, including the U.S., Europe, Canada, Australia, Egypt, Saudi Arabia and South Africa. It is currently marketed in the U.S. as SIMLANDI and under private label, in Europe as HUKYNDRA, in Canada as SIMLANDI and in Australia as ADALACIP. Dossiers are also under review in multiple countries globally.
About AVT04 (ustekinumab)
AVT04 is a monoclonal antibody and a biosimilar to Stelara® (ustekinumab). It has been launched in Canada as JAMTEKI, in the EEA as UZPRUVO, and in Japan as USTEKINUMAB BS (F). It has been approved in the U.S. as SELARSDI. Dossiers are also under review in multiple countries globally.
Sources
[1] IQVIA [2] Entyvio product information, EMA.
Use of trademarks
Entyvio is a trademark of Millennium Pharmaceuticals, Inc. Humira is a registered trademark of AbbVie Inc. Stelara is a registered trademark of Johnson & Johnson Inc.
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. Two biosimilars, to Humira® (adalimumab) and Stelara® (ustekinumab) are already approved and marketed in multiple global markets. The current development pipeline includes nine disclosed 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), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Dr. Reddy’s (EEA, UK and US), Biogaran (FR), 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 https://www.alvotech.com.
None of the information on the Alvotech website shall be deemed part of this press release.
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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 its ability to complete clinical patient studies successfully and receive marketing authorization, estimates with respect to its development programs and trials, including design, duration, timing, recruitment costs, screening and enrollment for those trials, including the ongoing AVT16-GL-C01 trial, addressable market size of Alvotech’s biosimilars and biosimilar candidates, Alvotech’s 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 submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, and market launches. 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Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (1) the ability to raise substantial additional funding, which may not be available on acceptable terms or at all; (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 revenue, expenses and profitability; (6) Alvotech’s ability to develop, manufacture and commercialize the products and product candidates in its pipeline; (7) the ability of Alvotech or its partners to enroll and retain patients in clinical studies; (8) the ability of Alvotech or its partners to gain approval from regulators for planned clinical studies, study plans or sites; (9) the ability of Alvotech’s partners to conduct, supervise and monitor existing and potential future clinical studies, which may impact development timelines and plans; (10) 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; (11) the success of Alvotech’s current and future collaborations, joint ventures, partnerships or licensing arrangements; (12) Alvotech’s ability, and that of its commercial partners, to execute their commercialization strategy for approved products; (13) Alvotech’s ability to manufacture sufficient commercial supply of its approved products; (14) the outcome of ongoing and future litigation regarding Alvotech’s products and product candidates; (15) the impact of worsening macroeconomic conditions, including rising inflation and interest rates and general market conditions, conflicts in Ukraine, the Middle East and other global geopolitical tension, on the Company’s business, financial position, strategy and anticipated milestones; and (16) 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. 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CONTACTS
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FAQ
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