- ADVANZ PHARMA secures rights to commercialize Alvotech’s biosimilar candidate for Eylea® in Europe
- ADVANZ PHARMA will leverage its existing specialty and hospital capabilities in Europe to ensure successful market registration, commercialization, and patient access
REYKJAVIK, ICELAND and LONDON, UK (June 18, 2024) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and ADVANZ PHARMA, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the companies have entered into an exclusive partnership agreement regarding the supply and commercialization of Alvotech’s proposed biosimilar to Eylea® (aflibercept). Alvotech is currently developing AVT06, a proposed biosimilar to Eylea® low dose (2 mg) and AVT29 a biosimilar candidate for Eylea® high dose (8 mg).
Eylea® is a widely used biologic for the treatment of eye disorders, including diseases which can lead to vision loss or blindness, such as wet AMD, macular edema, and diabetic retinopathy. In 2023, reported sales of Eylea® in Europe were $2.9 billion [1].
Under the agreement Alvotech will be responsible for development and commercial supply of AVT06 and AVT29 and ADVANZ PHARMA will be responsible for registration and commercialization. ADVANZ PHARMA has exclusive commercialization rights in Europe, except for Germany and France where the rights are semi-exclusive. The commercialization agreement includes an upfront payment to Alvotech with subsequent payments upon certain development and commercialization milestones.
"We value our growing partnership with Advanz Pharma which started early last year and has now been expanded to a total of seven biosimilar candidates. We share a common vision for the growth of the biosimilars market and a strong commitment to providing broader patient access to more affordable biologics,” said Anil Okay, Chief Commercial Officer of Alvotech.
Susanna El-Armale, Chief Corporate Development Officer at ADVANZ PHARMA, said: “We are excited to reinforce our collaboration with Alvotech by adding an impactful and meaningful product to our growing pipeline. This partnership leverages our combined strengths and reinforces ADVANZ PHARMA as a partner of choice for the commercialization of specialty pharmaceuticals in Europe.”
In January 2024 Alvotech announced positive top-line results from a confirmatory patient study evaluating the efficacy, safety, and immunogenicity of AVT06 compared with Eylea® in patients with neovascular (wet) AMD. The study met its primary endpoint, with results demonstrating therapeutic equivalence between Alvotech’s biosimilar candidate and Eylea®.
In February 2023 Alvotech and ADVANZ PHARMA announced that the companies had entered into an exclusive agreement for the commercialization of AVT23, a proposed biosimilar to Xolair® (omalizumab). The agreement covers the European Economic Area, UK, Switzerland, Canada, Australia, and New Zealand. In May 2023 Alvotech and ADVANZ PHARMA announced that the companies had expanded their partnership to include biosimilar candidates to Simponi® (golimumab) and Entyvio® (vedolizumab) and as well as three additional early-stage, undisclosed biosimilar candidates.
About AVT06/AVT29
AVT06/AVT29 is a recombinant fusion protein and a biosimilar candidate to Eylea® (aflibercept), which binds vascular endothelial growth factors (VEGF), inhibiting the binding and activation of VEGF receptors, neovascularization, and vascular permeability [2]. AVT06/AVT29 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.
Sources
[1] IQVIA sales data
[2] https://www.regeneron.com/downloads/eylea_fpi.pdf
Use of Trademarks
Eylea® is a registered trademark of Regeneron Pharmaceuticals 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. Alvotech’s current pipeline includes eight 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), 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.
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About ADVANZ PHARMA
Partner of choice in specialty, hospital, and rare disease medicines. ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients’ lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. Our headquarters are in London, UK. We have commercial sales in more than 90 countries globally and have a direct commercial presence in more than 20 countries, including key countries in Europe, the US, Canada, and Australia, a Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialization partner network. ADVANZ PHARMA’s product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, oncology, CNS, and, more broadly, rare disease medicines. Our ambition is to be a partner of choice for the commercialization of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with biopharma and development companies to bring medicines to patients. We can only achieve this due to our dedicated and highly qualified employees, acting in line with our company values of entrepreneurship, speed, and integrity.
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ADVANZ PHARMA Forward Looking Statements
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