Kashiv BioSciences Enters Into Exclusive Licensing Agreement With Amneal For Commercialization Of A Proposed Biosimilar To XOLAIR

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.