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

Rhea-AI Summary

Kashiv BioSciences has entered into an exclusive licensing agreement with Amneal Pharmaceuticals for the U.S. commercialization of ADL018, a proposed biosimilar to XOLAIR® (omalizumab).

ADL018 is currently in Phase III clinical trials, which began in Q3 2023. Omalizumab, a monoclonal antibody targeting IgE, is used to treat conditions like severe allergic asthma and chronic rhinosinusitis with nasal polyps.

This collaboration builds on the successful U.S. biosimilar partnership between the two companies for oncology products RELEUKO® and FYLNETRA®.

Annual U.S. sales for XOLAIR® were approximately $3.2 billion as of April 2024. Financial terms of the agreement were not disclosed.

Positive

• Exclusive licensing agreement with Amneal for ADL018 in the U.S. market.
• ADL018 is in Phase III clinical trials, a important step towards market approval.
• The current U.S. market for XOLAIR® is valued at approximately $3.2 billion annually.
• Success builds on previous collaborations for RELEUKO® and FYLNETRA®.
• Potential expansion into new therapeutic areas beyond oncology.

Negative

• No disclosure of financial terms or specific revenue projections.

Financial Analyst

The exclusive licensing agreement between Kashiv BioSciences and Amneal Pharmaceuticals for a proposed biosimilar to XOLAIR® (omalizumab) holds significant financial implications for both companies. XOLAIR® is a major product with annual sales of $3.2 billion in the U.S. as of April 2024. The introduction of a biosimilar could capture a notable market share, potentially generating substantial revenues for Kashiv and Amneal. The partnership builds on the existing success of RELEUKO® and FYLNETRA®, indicating a strong commercial relationship and execution capabilities.

Investors should consider the market dynamics of biosimilars. Unlike generic drugs, biosimilars are clinically equivalent but are not exact copies of their reference products and they often face challenges related to market acceptance, pricing and regulatory requirements. However, the growing acceptance of biosimilars in the U.S. market can provide a promising outlook.

Short-term impacts might be limited due to the ongoing Phase III clinical trials and subsequent regulatory approval process. However, long-term, the successful commercialization of ADL018 could significantly benefit both companies by capturing a share of the multibillion-dollar market for omalizumab, contributing to revenue diversification, especially for Amneal as it expands beyond oncology.

Medical Research Analyst

From a medical research perspective, the licensing agreement for the biosimilar ADL018, which targets free IgE, holds clinical significance for several chronic conditions, including severe persistent allergic asthma, CRSwNP, food allergies and chronic spontaneous urticaria. The ongoing Phase III clinical trial will be important in determining the biosimilar's efficacy and safety compared to XOLAIR®.

For patients and healthcare providers, the introduction of a biosimilar could offer a more cost-effective alternative to XOLAIR®. This is particularly relevant in chronic conditions that require long-term treatment, potentially improving patient access and adherence to therapy. Moreover, with the increasing financial burden of biologic therapies, a successful biosimilar could drive cost savings in the healthcare system.

However, it is essential to consider potential challenges in patient and provider acceptance of biosimilars versus original biologics. Education around the equivalency and safety of biosimilars will be key to achieving a successful market entry.

Market Research Analyst

The move to commercialize a biosimilar to XOLAIR® indicates a strategic expansion for both Kashiv BioSciences and Amneal Pharmaceuticals. By partnering on ADL018, they are venturing into a high-value therapeutic area beyond oncology. The estimated $3.2 billion U.S. market for XOLAIR® presents a lucrative opportunity for market penetration.

Biosimilars typically face less price erosion compared to traditional generics due to their complex manufacturing process and clinical trial requirements. Thus, the financial margins on biosimilars can be more favorable. The success of previous biosimilar products by these companies suggests they are well-positioned to navigate the regulatory and market landscapes.

In the long term, the diversification into areas such as allergic asthma and chronic urticaria can help stabilize and grow revenue streams, reducing reliance on any single therapeutic category. This strategic breadth can also protect against market volatility in individual sectors.

Nevertheless, competition in the biosimilar market is intensifying and sustained investment in marketing and education will be necessary to establish a strong foothold.

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

PISCATAWAY, N.J.--(BUSINESS WIRE)-- 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.

Cautionary Statement on Forward-Looking Statements

Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements.

The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events, including with respect to future market conditions, company performance and financial results, operational investments, business prospects, new strategies and growth initiatives, the competitive environment, and other events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Amneal.

Such risks and uncertainties include, but are not limited to: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to obtain exclusive marketing rights for our products; our revenues are derived from the sales of a limited number of products, a substantial portion of which are through a limited number of customers; the impact of a prolonged business interruption within our supply chain; the continuing trend of consolidation of certain customer groups; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; our dependence on information technology systems and infrastructure and the potential for cybersecurity incidents; our ability to attract, hire and retain highly skilled personnel; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; the risk of claims brought against us by third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to Food and Drug Administration product approval requirements; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; our dependence on third-party agreements for a portion of our product offerings; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; our potential expansion into additional international markets subjecting us to increased regulatory, economic, social and political uncertainties; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; the impact of global economic, political or other catastrophic events; our obligations under a tax receivable agreement may be significant; and the high concentration of ownership of our Class A common stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in Amneal’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in Amneal’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240702506268/en/

Dr. Paras Vasanani

Head of BD&L, Portfolio Strategy

paras.vasanani@kashivbio.com



Anthony DiMeo

VP, Investor Relations & Media

anthony.dimeo@amneal.com

Source: Kashiv BioSciences, LLC

FAQ

What is the recent agreement between Kashiv BioSciences and Amneal Pharmaceuticals?

Kashiv BioSciences has entered into an exclusive licensing agreement with Amneal Pharmaceuticals for the U.S. commercialization of ADL018, a proposed biosimilar to XOLAIR® (omalizumab).

What is ADL018?

ADL018 is a proposed biosimilar to XOLAIR® (omalizumab) developed by Kashiv BioSciences, currently in Phase III clinical trials.

What is the market potential for ADL018?

The U.S. market for XOLAIR® is valued at approximately $3.2 billion annually, indicating significant market potential for ADL018.

How does the agreement benefit Amneal Pharmaceuticals?

The agreement allows Amneal to expand its biosimilar portfolio and enter new therapeutic areas, potentially increasing patient access and driving cost savings in the U.S. healthcare system.

What are the previous successful collaborations between Kashiv and Amneal?

Kashiv and Amneal previously collaborated on the U.S. commercialization of oncology biosimilars RELEUKO® and FYLNETRA®.