Alvotech Enters into Exclusive Licensing Agreement with Kashiv BioSciences for Development and Commercialization of a Proposed Biosimilar to Xolair® (omalizumab)
REYKJAVIK, Iceland and PISCATAWAY, N.J., Oct. 03, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Kashiv Biosciences LLC (“Kashiv”), a fully integrated biopharmaceutical company, today announced that they have entered into an exclusive licensing agreement for AVT23 (also called ADL018), a proposed biosimilar to Xolair® (omalizumab), which is currently in clinical development.
The agreement covers all 27 countries of the European Union, the UK, Australia, Canada, and New Zealand. Under terms of the agreement, Alvotech will receive an exclusive license to commercialize AVT23, which will be developed and manufactured by Kashiv. Kashiv will receive an upfront payment and is eligible for subsequent milestone payments and royalties.
“We are very pleased to enter into this exclusive development and commercialization agreement for omalizumab. This demonstrates how Alvotech can leverage its platform and pursue attractive markets either by developing and manufacturing products in-house, or through in-licensing. Here, we can deploy Alvotech’s market access expertise as well as leveraging our global commercial partnerships,” said Robert Wessman, chairman and CEO of Alvotech.
“We are delighted to partner commercial rights to our omalizumab biosimilar program to Alvotech, a global biosimilar company, for multiple major geographies. With this exclusive development and commercialization agreement, Kashiv continues to build upon its strong track record of developing and manufacturing high-quality biosimilars for commercial partners worldwide. We look forward to continued enrollment of patients in our global Phase III clinical study to expand access to this treatment for patients,” said Dr. Sandeep Gupta, CEO of Kashiv.
Omalizumab is a humanized monoclonal antibody that targets free IgE. Xolair, which contains omalizumab, is indicated for diseases such as severe persistent allergic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP) and chronic spontaneous urticaria . Global sales of Xolair in the last twelve months preceding June 30, 2023, were about $3.7 billion .
AVT23 is a proposed biosimilar to Xolair (omalizumab). AVT23 is an investigational compound and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.
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.
About Kashiv Biosciences, LLC
Kashiv Biosciences, LLC is a fully integrated biopharmaceutical company with global R&D, clinical, regulatory, and manufacturing capabilities for developing biosimilars and other complex products. The Company has a robust pipeline of seven biosimilars, and multiple 505(b)(2) and complex peptide generic products in development. Kashiv is headquartered in Piscataway, NJ with FDA-approved GMP manufacturing facilities in Chicago, IL and state-of-the-art R&D infrastructure in Ahmedabad, India. For more information, visit www.kashivbiosciences.com.
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 https://www.ema.europa.eu/en/documents/product-information/xolair-epar-product-information_en.pdf  Based on latest quarterly filings by F. Hoffmann-La Roche Ltd and Novartis AG. Xolair is a registered trademark of Novartis AG
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