Kashiv Biosciences LLC (“Kashiv”), a fully integrated biopharmaceutical company, and Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that they have entered into an exclusive licensing agreement for ADL018 (also called AVT23), a proposed biosimilar to Xolair® (omalizumab), which is 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 ADL018, 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 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 are actively evaluating commercial partners for other major geographies to maximize the potential of this drug. 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.

“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.

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 [1]. Global sales of Xolair in the last twelve months preceding June 30, 2023, were about $3.7 billion [2].

About ADL018

ADL018 is a proposed biosimilar to Xolair (omalizumab). ADL018 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.

Contacts

Kashiv
Dr. Paras Vasanani
Head of BD&L, Portfolio, Strategy
paras.vasanani@kashivbio.com

Alvotech

Senior Director of Investor Relations and Global Communication
Benedikt Stefansson
alvotech.ir@alvotech.com

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