• ADL018 (omalizumab biosimilar) is Kashiv’s most advanced stage biosimilar candidate, after receiving FDA approval for Releuko® and Fylnetra® in 2022.
• Kashiv announced completion of a successful global Phase 1 clinical study in healthy volunteers for ADL018 in June 2023.

Kashiv BioSciences, LLC (“Kashiv” or the “Company”) today announced that it has enrolled the first patient in its Phase III clinical study involving ADL018, the Company’s biosimilar candidate to XOLAIR^®. The objective of the study is to compare ADL018 and XOLAIR^® in terms of efficacy, safety, tolerability, and immunogenicity in patients with chronic idiopathic/spontaneous urticaria (CSU) who remain symptomatic on H1 antihistamine treatment. The study is expected to enroll 600 patients globally in sites across the United States, Europe, and India (NCT05774639).

Dr. Sandeep Gupta, CEO of Kashiv, said:

“We are pleased to announce enrollment of the first patient in our global Phase III study for ADL018. This is an important step in bringing Kashiv’s third biosimilar to market and further demonstrates the robust capabilities of our integrated R&D and manufacturing platform. By relentlessly focusing on quality and cost-effective development, we aim to continue advancing our deep pipeline of affordable biosimilars to improve patients’ lives worldwide.”

Dr. Chandramauli Rawal, COO of Kashiv, added:

“The initiation of our Phase III study for ADL018 is yet another milestone in our continuous effort to develop high-quality biosimilars. It is also a testament to countless hours of hard work and preparation from our talented team. We are confident in our ability to execute this important study in a timely manner and look forward to continued recruitment and patient follow-up.”

About ADL018

ADL018 is a humanized monoclonal antibody that inhibits the binding of IgE to the high-affinity IgE receptor (FcεRI) on the surface of mast cells and basophils. It is being developed as a biosimilar candidate to XOLAIR^® (omalizumab), an injectable prescription medicine approved to treat CSU in people 12 years of age and older who continue to have hives that are not controlled with H1 antihistamine treatment. Omalizumab is also approved to treat moderate to severe persistent asthma in people 6 years of age and older whose asthma symptoms are not well controlled with asthma medicines called inhaled corticosteroids; and chronic rhinosinusitis with nasal polyps in people 18 years of age and older.

ADL018 has the same pharmaceutical form, dosage strength, route of administration and dosing regimen as United States and European Union (EU)-approved omalizumab. Global sales of XOLAIR^® in the last twelve months preceding June 30, 2023 were about $3.7 billion [1].

About Chronic Spontaneous Urticaria

Chronic spontaneous urticaria, formerly also known as chronic idiopathic urticaria and chronic urticaria, is a common condition that has major detrimental effects on patients’ quality of life, with sleep deprivation and psychiatric comorbidity being frequent. It also has a large impact on society in terms of direct and indirect health care costs as well as reduced performance at work and in private life. At any time, 0.5-1% of the population suffers from the disease (point prevalence). In most patients, an underlying cause cannot be identified making a causal and/or curative treatment difficult. Nonsedating H₁-antihistamines are the mainstay of symptomatic therapy, but treatment with licensed doses relieves symptoms effectively only in < 50% of patients.

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 & 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.

[1] 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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