Amneal Expands Biosimilars Portfolio to Eight Products with Addition of Omalizumab Biosimilar

Rhea-AI Summary

Amneal Pharmaceuticals has expanded its biosimilar portfolio to include omalizumab, a biosimilar referencing XOLAIR®. Omalizumab is used to treat chronic conditions like severe allergic asthma and chronic urticaria. Developed by Kashiv BioSciences, this biosimilar is currently in a Phase III clinical trial initiated in Q3 2023. With this addition, Amneal's biosimilar portfolio now includes eight products, covering a new therapeutic area beyond oncology. The U.S. annual sales for XOLAIR® reached approximately $3.2 billion as of April 2024. Financial terms were not disclosed, but the associated costs are accounted for in Amneal's guidance.

Positive

• Amneal's biosimilar portfolio expands to eight products.
• Introduction of omalizumab extends the portfolio into allergy treatments.
• Omalizumab biosimilar is in Phase III clinical trials as of Q3 2023.
• U.S. annual sales of XOLAIR® are approximately $3.2 billion.

Negative

• None.

Insights

Medical Research Analyst

The inclusion of omalizumab in Amneal's biosimilar portfolio represents a significant expansion into allergy treatments, diversifying beyond their traditional focus on oncology. Omalizumab, a humanized monoclonal antibody, targets free immunoglobulin E (IgE) and is used for conditions like severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps. As it is still in Phase III clinical trials, its future commercial success hinges on the outcomes of these trials and subsequent FDA approval.

If successful, introducing an omalizumab biosimilar could provide a more cost-effective alternative to the branded drug XOLAIR®, potentially capturing a significant share of the market, given the high annual sales figures of $3.2 billion for XOLAIR®. This could translate to improved patient access and affordability in the U.S. healthcare system. However, the competitive landscape for biosimilars is intense and Amneal will need to navigate regulatory, production and market penetration challenges effectively.

Financial Analyst

From a financial perspective, the addition of omalizumab to Amneal's portfolio could bolster the company's revenue streams, particularly if the biosimilar captures even a 10 market share of the $3.2 billion annual sales of XOLAIR®. This move aligns with Amneal's strategy to expand its biosimilar offerings, which could help mitigate risks associated with market reliance on a few key products.

Given that the financial terms of the transaction were not disclosed and incremental expenses are accounted for in Amneal's guidance, investors should monitor upcoming earnings reports for more details on the financial impact. The success of this initiative will largely depend on market acceptance and competitive positioning. The absence of disclosed financial terms also suggests the need for cautious optimism.

Builds on U.S. biosimilar portfolio of seven products with three commercial and four in pipeline

8^th biosimilar expands portfolio into allergy treatments, a new therapeutic area

BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the addition of omalizumab, referencing XOLAIR^®, to its biosimilar pipeline.

Omalizumab is a humanized monoclonal antibody which targets free immunoglobulin E (IgE). 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. It 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 excited to further grow our biosimilar pipeline 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.

“We are pleased to partner with Amneal 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^® and FYLNETRA^®, and advancement of additional peg-filgrastim programs. 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.

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 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, the Company 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, the Company 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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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 the Company. 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 the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’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/20240701356353/en/

Contact

Anthony DiMeo

VP, Investor Relations & Media

anthony.dimeo@amneal.com

Source: Amneal Pharmaceuticals, Inc.

FAQ

What recent addition to its biosimilar portfolio did Amneal Pharmaceuticals announce?

Amneal Pharmaceuticals announced the addition of omalizumab, a biosimilar referencing XOLAIR®.

What conditions is the omalizumab biosimilar used to treat?

The omalizumab biosimilar is used to treat severe persistent allergic asthma, chronic rhinosinusitis with nasal polyps, food allergies, and chronic spontaneous urticaria.

When did the Phase III clinical trial for the omalizumab biosimilar begin?

The Phase III clinical trial for the omalizumab biosimilar began in the third quarter of 2023.

What is the significance of the omalizumab biosimilar addition to Amneal's portfolio?

The addition of the omalizumab biosimilar expands Amneal's portfolio into allergy treatments, covering a new therapeutic area beyond oncology.

What are the U.S. annual sales for XOLAIR®?

The U.S. annual sales for XOLAIR® were approximately $3.2 billion for the 12 months ended April 2024.