Kashiv BioSciences Enters into Exclusive Licensing Agreement with Amneal for Commercialization of a Proposed Biosimilar to XOLAIR® (Omalizumab)

Builds on successful U.S. biosimilar partnership of 2 oncology products (RELEUKO® & FYLNETRA®)

ADL018 is Kashiv’s lead pipeline biosimilar program, currently in Phase III

Kashiv BioSciences, LLC (“Kashiv” or the “Company”) today announced that it has entered into an exclusive licensing agreement for ADL018, a proposed biosimilar to omalizumab referencing XOLAIR®, with Amneal Pharmaceuticals, Inc. (“Amneal”) for the United States.

Omalizumab, which targets free IgE, is a humanized monoclonal antibody. It is an injectable prescription drug used to treat a number of chronic conditions such as severe persistent allergic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), food allergies, and chronic spontaneous urticaria, and is typically administered in a hospital or clinic setting. The biosimilar was developed by Kashiv BioSciences, LLC and is currently in a Phase III clinical trial, which began in the third quarter of 2023.

“We are pleased to partner with Amneal, a leader in commercialization of biologics in the US, on our most advanced pipeline product, ADL018, a proposed biosimilar to XOLAIR®. We are building on our highly productive partnership with the commercial success of RELEUKO® & FYLNETRA®. Kashiv is one of a few companies based in the United States to manufacture and receive marketing authorization of multiple biosimilars. By relentlessly focusing on quality and cost-effective development, Kashiv continues to build upon its strong track record of developing and manufacturing high-quality, affordable biosimilars to improve patients’ lives worldwide,” said Dr. Sandeep Gupta, Chief Executive Officer of Kashiv.

“We are excited to further grow our biosimilar portfolio with the addition of omalizumab and expand into a new therapeutic area beyond oncology. We are building on the strong success of our first commercial biosimilars. Amneal is committed to providing affordable biologic medicines which will increase access and choice to patients and providers, and drive cost savings to the U.S. healthcare system,” said Sean McGowan, Vice President, Biosimilars and Branded Oncology.

According to IQVIA®, U.S. annual sales for XOLAIR® for the 12 months ended April 2024 were approximately $3.2 billion. XOLAIR® is a registered trademark of Novartis AG.

The financial terms of the transaction were not disclosed, and any incremental expenses associated with these products are contemplated within Amneal’s guidance.

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 7+ 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.

About Amneal

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceutical products, primarily within the United States. In its Generics segment, Amneal is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, Amneal is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com.

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