Amneal Expands Portfolio with Addition of Icosapent Ethyl Acid Soft Gel Capsules

Rhea-AI Summary

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) partners with Strides Pharma Science Limited to commercialize Icosapent ethyl acid soft gel capsules, a product referencing VASCEPA®. The product, in-licensed from Strides, will be launched in the fourth quarter of 2023. Icosapent ethyl is indicated to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. Amneal plans to launch over 40 new products in 2023, including Icosapent ethyl, as part of their portfolio expansion strategy.

Positive

• Partnership with Strides Pharma Science Limited opens up new commercialization opportunities for Amneal Pharmaceuticals, expanding their product portfolio and market reach.
• The addition of Icosapent ethyl acid soft gel capsules aligns with Amneal's plan to launch over 40 new products in 2023, indicating a robust growth strategy.
• The partnership reflects Amneal's commitment to providing essential medicines and expanding their product offerings to benefit patients with severe hypertriglyceridemia.

Negative

• None.

- Partnering with Strides to commercialize recently U.S. FDA approved product

- Represents another new product launch for Amneal in 2023

BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) and Strides Pharma Science Limited (“Strides”) today announced the addition of Icosapent ethyl acid soft gel capsules, a product referencing VASCEPA^®. The product has been in-licensed from Strides, a global pharmaceutical manufacturer, and will be commercialized by Amneal starting in the fourth quarter of 2023.

Icosapent ethyl acid soft gel capsules 0.5g and 1g is an ethyl ester of eicosapentaenoic acid (EPA) that is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.

“We are on-track to launch over 40 new products in 2023,” said Andy Boyer, Executive Vice President, Amneal Generics. “The launch of Icosapent ethyl is another essential medicine that we’ve added to our portfolio.”

“We are thrilled to announce our partnership with Amneal Pharmaceuticals for Icosapent ethyl acid soft gelatin capsules. This partnership is a testament to our commitment to excellence and the pursuit of cutting-edge solutions. By combining our resources, expertise, and shared passion, we are confident that we will achieve remarkable outcomes that benefit not only our organizations but also our valued customer and stakeholders,” said Aditya Kumar, Vice President Business Development, Strides Pharma Science Limited.

Important Safety Information: Adverse effects reported with VASCEPA^® include musculoskeletal pain, peripheral edema, constipation, gout, and atrial fibrillation. For full prescribing information, see package insert located here.

About Amneal

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully integrated global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of approximately 270 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.

About Strides

Strides, listed on the BSE Limited (532531) and National Stock Exchange of India Limited (STAR), is a global pharmaceutical company headquartered in Bengaluru, India. The Company mainly operates in the regulated markets and has an “in Africa for Africa” strategy along with an institutional business to service donor-funded markets. The Company’s global manufacturing sites are located in India (Chennai, Puducherry and two locations in Bengaluru), Singapore, Italy (Milan), Kenya (Nairobi) and the United States (New York). The Company focusses on “difficult to manufacture” products that are sold in over 100 countries. Additional information is available at the Company’s website at www.strides.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, including international expansion; expected or estimated operating results and financial performance; the Company’s growth prospects and opportunities as well as its strategy for growth; product development and launches; the successful commercialization and market acceptance of new products, 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 ability to manage our growth through acquisitions and otherwise; 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 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; our ability to complete the proposed holding company reorganization on the anticipated timeline or at all and to realize the expected benefits of such reorganization; 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 ability to secure satisfactory terms when negotiating a refinancing or other new indebtedness; our dependence on third-party agreements for a portion of our product offerings; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; 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 product liability and other claims against us by consumers and other 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 potential expansion into additional international markets subjecting us to increased regulatory, economic, social and political uncertainties, including recent events affecting the financial services industry; 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 ability to attract, hire and retain highly skilled personnel; 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/20231201265945/en/

Amneal Investor

Anthony DiMeo

Head of Investor Relations

anthony.dimeo@amneal.com



Strides



Badree Komandur

Executive Director - Finance & Group CFO

+91 80 6784 0747



Strides Pharma Science Limited:



CIN: L24230MH1990PLC057062



Regd. Office: 201, ‘Devavrata’, Sector – 17, Vashi, Navi Mumbai – 400 703

Corp. Office: Strides House, Bannerghatta Road, Bengaluru – 560 076



Corporate Communication:



Pallavi Panchmatia : +91 80 6784 0193,

pallavi.panchmatia@strides.com



PR Consultancy:



Fortuna PR

K Srinivas Reddy: +91 90005 27213

srinivas@fortunapr.com



Boni Mukherjee: +91 96186 82208

boni@fortunapr.com

Source: Amneal Pharmaceuticals, Inc.

FAQ

What is the product being commercialized by Amneal Pharmaceuticals in partnership with Strides Pharma Science Limited?

Icosapent ethyl acid soft gel capsules, a product referencing VASCEPA®.

When will the product be launched?

The product is set to be launched in the fourth quarter of 2023.

What is the indication for Icosapent ethyl acid soft gel capsules?

It is indicated to reduce triglyceride levels in adult patients with severe hypertriglyceridemia.

How many new products does Amneal Pharmaceuticals plan to launch in 2023?

Amneal plans to launch over 40 new products in 2023, including Icosapent ethyl.

What is the safety information for VASCEPA®?

Adverse effects reported with VASCEPA® include musculoskeletal pain, peripheral edema, constipation, gout, and atrial fibrillation. For full prescribing information, see package insert located here.